Associate Director, Regulatory Affairs CMC

AbbVie Inc.Waltham

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

To be successful in this role, you should possess a strong background in regulatory affairs, particularly within the biopharmaceutical sector. A Bachelor's degree in a relevant field is required, with a preference for advanced degrees. You should have extensive experience (typically 8+ years) in regulatory submissions and a solid understanding of CMC regulations, as well as the ability to effectively communicate complex information to diverse audiences.

About the job

Join AbbVie as an Associate Director in Regulatory Affairs with a focus on Chemistry, Manufacturing, and Controls (CMC). In this pivotal role, you will lead cross-functional teams to ensure compliance with regulatory requirements while advancing our innovative therapies. As a leader, you will drive the development of CMC submission strategies, collaborate with internal and external stakeholders, and support the overall regulatory strategy for our product pipeline.

About AbbVie Inc.

AbbVie is a global biopharmaceutical company committed to developing innovative medicines that address some of the world's most complex health challenges. Our mission is to leverage our expertise in science and technology to provide solutions that improve the quality of life for patients worldwide. With a robust pipeline and a commitment to excellence, AbbVie is at the forefront of healthcare innovation.

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Associate Director/Director of Analytical & GMP Quality Assurance Operations

Crescent Biopharma

Full-time|On-site|Waltham, MA

At Crescent Biopharma, we aspire to transform the landscape of oncology by developing cutting-edge therapies tailored for cancer patients. Our innovative pipeline includes a leading PD-1 x VEGF bispecific antibody, alongside state-of-the-art antibody-drug conjugates. By harnessing diverse therapeutic modalities and established targets, we aim to expedite the…

Mar 10, 2026

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Director of Global Quality Assurance in GCP/GLP

Zenas Bio

Full-time|On-site|Waltham, MA

About the Role Zenas Bio is looking for a Director of Global Quality Assurance with expertise in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). This leader will guide the company’s quality assurance activities and maintain compliance with regulatory standards. Key Responsibilities Oversee global quality assurance processes related to GCP and GLP. Ensure all practices meet current regulatory requirements and industry standards. Location This position is based in Waltham, MA.

Apr 14, 2026

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Director of Clinical Quality Assurance

Oruka Therapeutics

Full-time|$213K/yr - $240K/yr|Remote|Waltham, Massachusetts, United States

About Us:At Oruka Therapeutics (Nasdaq: ORKA), we are pioneering innovative biologics aimed at transforming the treatment landscape for chronic skin disorders. Our mission is to empower individuals battling chronic skin conditions, such as plaque psoriasis, by providing them with the utmost freedom from their ailments, achieving significant disease clearance through infrequent dosing, potentially just once or twice yearly. Our proprietary collection of antibodies, meticulously crafted by Paragon Therapeutics, targets the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory conditions. To learn more, visit www.orukatx.com.As we expand our core team, we are on the lookout for exceptional talent across various functional areas—individuals who seek more than just employment, but rather a chance to be part of something transformative. We value passion for making a difference and contributions to fostering an engaged, inclusive, and positive workplace culture.Job Title: Director of Clinical Quality AssuranceLocation: Remote; candidates located in the Waltham, MA area are preferred.Role Overview:The Director of Clinical Quality Assurance will provide strategic leadership and oversight for Oruka's clinical development initiatives, focusing primarily on Good Clinical Practice (GCP) and associated quality systems that support clinical trials. This role will establish, enhance, and oversee clinical quality processes appropriate to each phase, ensuring comprehensive supervision of clinical trial execution and vendor performance while preparing for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.This position will collaborate closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure compliance with GCP, relevant global regulations, internal procedures, and protocol requirements throughout the clinical trial lifecycle. The Director of Clinical QA will proactively contribute quality insights, support continuous improvement initiatives, and help cultivate a quality-centric culture as the organization progresses with its pipeline.Key Responsibilities:Clinical Quality Oversight: Ensure compliance with GCP and applicable regulatory requirements for new and ongoing clinical studies.

Apr 9, 2026

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Associate Director/Director of Analytical Development and Validation - Tech Operations (Biologics)

Oruka Therapeutics

Full-time|$182K/yr - $240K/yr|Hybrid|Remote; Waltham, Massachusetts, United States

About Us:Oruka Therapeutics (Nasdaq: ORKA) is pioneering innovative biologic therapies aimed at transforming the treatment landscape for chronic skin conditions. Our mission is to empower individuals suffering from chronic skin diseases, such as plaque psoriasis, by providing unprecedented freedom from their ailments through treatments administered as infrequently as once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies developed by Paragon Therapeutics, targeting the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory disorders. For more details, visit www.orukatx.comAs we fortify our core team, we are on the lookout for exceptional talent across various domains. We seek individuals who are not just looking for employment, but are eager to contribute to a larger purpose. If you are passionate about making a significant impact and are keen on fostering an engaged, inclusive, and positive workplace culture, we want to hear from you.Job Title: Associate Director/Director of Analytical Development and Validation - Tech Operations (Biologics)Location: Hybrid – Waltham, MA. Candidates are expected in the office 3 days a week. Remote considerations may apply.Role Overview:The Associate Director/Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities that support the development, validation, and lifecycle management of biologic drug products, particularly monoclonal antibodies. This position will oversee method validation and comparability initiatives essential for BLA/MAA submissions, process modifications, and commercial readiness, collaborating closely with CMC, Quality, Regulatory Affairs, and external partners.The ideal candidate is a proactive leader with extensive experience in analytical method validation, device functional testing, and regulatory frameworks for late-stage biologics. You will guide teams through intricate technical and compliance milestones, making this a highly visible role within the CMC team. Join our expanding organization and play a crucial part in supporting multiple programs’ analytical activities, facilitating the release of supplies for clinical trials, and preparing for commercialization in the US, Canada, and EU.

Apr 10, 2026

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Associate Director of Sales Operations

Deciphera Pharmaceuticals, Inc.

Full-time|On-site|Waltham

Deciphera Pharmaceuticals, Inc. is on the lookout for a seasoned Associate Director of Sales Operations to spearhead and enhance our field-facing operational strategies. This pivotal role will support the establishment of a high-performing Commercial field team, particularly focused on facilitating a successful brand launch. The successful candidate will ensure compliance, efficiency, and data-driven insights within field operations across our Hematology Franchise, playing a crucial role in ensuring operational readiness for product launches and ongoing excellence initiatives in the field.Key ResponsibilitiesFormulate and implement field operations strategies that align with both commercial and medical objectives.Manage field technology platforms including CRM systems, roster management, and reporting tools in collaboration with the IT department.Oversee territory design, roster management, and alignment processes to ensure compliance with coverage models.Coordinate onboarding operations with Training, HR, and Compliance teams.Direct the creation of field reports, dashboards, KPI tracking, and business insights.Ensure all field operations processes adhere to FDA, OIG, and corporate compliance standards.Lead continuous improvement initiatives aimed at enhancing scalability, efficiency, and quality.Collaborate effectively across functions including Sales, Marketing, Medical, Compliance, IT, HR, Legal, and Finance.

Feb 25, 2026

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Associate Director of Clinical Operations

Oruka Therapeutics

Full-time|$182K/yr - $208K/yr|Hybrid|Waltham, Massachusetts, United States

Oruka Therapeutics is developing biologics designed to change the treatment landscape for chronic skin conditions such as plaque psoriasis. The company focuses on long-lasting relief for patients, aiming for outcomes like disease clearance with infrequent dosing. Their pipeline includes proprietary antibodies created by Paragon Therapeutics, targeting the underlying causes of dermatologic and inflammatory diseases. More details about their work can be found at www.orukatx.com. Role overview The Associate Director of Clinical Operations will manage the setup and execution of clinical trials, supporting the Director of Clinical Operations within a specific therapeutic area. This position oversees multiple studies, combining strategic planning with day-to-day operational involvement to keep clinical programs on track and within budget. Responsibilities include handling operational details, anticipating challenges, and implementing solutions to ensure trial progress. The role requires someone who can move between leadership and hands-on work, maintaining a player/coach mindset throughout. What you will do Oversee all phases of clinical trial setup and execution across several studies Support the Director of Clinical Operations in a designated therapeutic area Balance strategic planning with direct, hands-on involvement in daily operations Identify and resolve operational challenges to maintain study timelines and budgets Requirements Demonstrated integrity and sound judgment in clinical operations Ability to shift between high-level oversight and direct involvement as needed Strong commitment to study goals and a collaborative approach Adaptability and resourcefulness in a biotech setting This hybrid role is based in Waltham, Massachusetts, with an expectation of three days onsite each week. The team values learning, growth, and a positive, inclusive culture.

Apr 22, 2026

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Senior Director of R&D Quality Assurance (GCP-GLP-GvP)

Crescent Biopharma

Full-time|On-site|Waltham, MA

Join Crescent Biopharma as a Senior Director of R&D Quality Assurance!Crescent Biopharma is on a mission to revolutionize oncology by developing cutting-edge therapies for cancer patients. Our clinical-stage pipeline showcases our leading program, a PD-1 x VEGF bispecific antibody, alongside innovative antibody-drug conjugates. Through the strategic utilization of diverse modalities and established therapeutic targets, we aim to swiftly propel potentially transformative treatments, whether as standalone therapies or in combination regimens targeting a variety of solid tumors.As a key leader in our Quality organization, the Senior Director, R&D Quality (GCP–GLP–GvP) will deliver both strategic and hands-on leadership in Quality Assurance across clinical and nonclinical domains.

Apr 30, 2026

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Director of Market Access Pricing & Analytics

Deciphera Pharmaceuticals, Inc.

Full-time|On-site|Waltham

As the Director of Market Access Pricing & Analytics, you will play a pivotal role within our US Market Access team. This leadership position is essential for delivering impactful insights that shape our pricing, contracting, and reimbursement strategies. You will leverage advanced analytics, strategic acumen, and cross-functional collaboration to support key business decisions aimed at enhancing patient access. In this role, you will identify opportunities, evaluate risks, align stakeholders, and translate data into actionable strategies to achieve our market access objectives.

Feb 9, 2026

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Director of Clinical Operations

Deciphera Pharmaceuticals, Inc.

Full-time|On-site|Waltham

Role Overview:The Director of Clinical Operations plays a pivotal role in ensuring that clinical stage programs meet both strategic and operational objectives in compliance with set timelines, budgets, and quality standards. This leadership position is vital in guiding the Clinical Operations team, shaping clinical program strategies, and fostering collaboration and transparency across multiple functions. The Director will work closely with both internal stakeholders and external partners to facilitate high-quality clinical trial execution within the dynamic landscape of a small-to-midsize biotech organization.Key Responsibilities:Program Strategy & Leadership (35%)Formulate and implement clinical program strategies that are aligned with corporate objectives. Lead the Clinical Operations team to optimize the allocation of resources across various programs.Clinical Trial Oversight (25%)Ensure that clinical trials are meticulously defined, planned, and executed in accordance with GCP, ICH, and FDA regulations. Monitor study timelines, budgets, and quality metrics to drive operational excellence.Regulatory & Documentation Support (15%)Assist in drafting key regulatory documents, ensuring that clinical program outputs meet submission requirements and regulatory standards.Vendor & CRO Management (15%)Oversee and manage Contract Research Organizations (CROs), vendors, and external partners to ensure that performance, deliverables, and financial accountability align with expectations.Team Development & Collaboration (10%)Cultivate a collaborative environment within Clinical Operations and exemplify leadership values. Encourage transparent communication, accountability, and operational discipline across the department.Other duties as assigned.

Dec 19, 2025

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Senior Manager, Global Quality Assurance in Technical Operations

Zenas BioPharma

Full-time|$140.8K/yr - $176K/yr|On-site|Waltham, MA

Zenas BioPharma is a pioneering biopharmaceutical company at the forefront of developing and commercializing transformative therapies for patients suffering from autoimmune diseases. Our strategic approach combines a seasoned leadership team with a rigorous process for acquiring and developing innovative product candidates globally. We are focused on delivering superior clinical benefits to patients affected by autoimmune disorders. We are advancing two late-stage flagship molecules: obexelimab and orelabrutinib. Obexelimab is our lead candidate, a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, aimed at inhibiting the activity of pathogenic B cells without causing depletion. This innovative therapy offers a self-administered subcutaneous injection regimen, addressing chronic autoimmune diseases effectively. Orelabrutinib, on the other hand, is a highly selective oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). We also have promising earlier-stage programs, including a preclinical oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor.We are on the lookout for exceptional talent who share our dedication to improving patient outcomes and possess a proven track record in global product acquisition, development, and commercialization. Joining Zenas provides an opportunity to thrive in a dynamic learning environment where individual and organizational success is paramount as we aspire to become a global leader in immunology and autoimmune disease management. Our core values—Transparency, Relationships, Urgency, Excellence, and Innovation—drive us toward TRUE Innovation!Position Summary:As the Senior Manager of Global Quality Assurance for Technical Operations, you will report directly to the Director of Global Quality Assurance for Medical Devices and Combination Products. This strategic role encompasses hands-on quality oversight for late clinical-stage and commercial manufacturing activities at Zenas BioPharma’s Contract Manufacturing Organizations (CMOs). You will ensure the highest standards of GMP compliance across our global operations, facilitate regulatory submissions and inspections, and drive continuous improvement initiatives alongside internal teams and external manufacturing partners. Your responsibilities will include overseeing batch manufacturing and testing, process validation, and ensuring inspection readiness to maintain robust product quality throughout the development lifecycle.

Apr 3, 2026

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Associate Director, Pharmacovigilance Scientist

Deciphera Pharmaceuticals, Inc.

Full-time|On-site|Waltham

As the Associate Director of Pharmacovigilance, you will play a crucial role in ensuring the safety and efficacy of our pharmaceutical products. You will lead a team dedicated to monitoring and evaluating adverse drug reactions, while also collaborating closely with regulatory bodies to uphold our commitment to patient safety. Your expertise will contribute significantly to our ongoing efforts in drug development and post-marketing surveillance. Join us in making a difference in the lives of patients around the world.

Apr 6, 2026

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Associate Director of Access Strategy

Sobi

Full-time|On-site|Waltham

As the Associate Director of Access Strategy at Sobi, you will play a pivotal role in shaping the strategies that enhance patient access to our innovative therapies. This position requires a strategic thinker who is passionate about improving healthcare accessibility and is adept at navigating the complexities of the healthcare landscape. You will work closely with cross-functional teams to develop and implement access strategies that align with our organizational goals and promote patient-centric outcomes.

Apr 30, 2026

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Associate Director, Regulatory Affairs CMC

AbbVie Inc.

Full-time|On-site|Waltham

Apr 30, 2026

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Quality Assurance Engineer in Manufacturing

Xometry

Full-time|$84K/yr - $109K/yr|On-site|Waltham, MA

At Xometry (NASDAQ: XMTR), we empower the industries of today and tomorrow by connecting visionary thinkers with manufacturers capable of turning their ideas into reality. Our digital marketplace equips manufacturers with the essential tools to expand their businesses while providing Fortune 1000 companies seamless access to global manufacturing capabilities.We are on the lookout for dynamic Quality Engineers to join our team and support our rapid growth. Are you someone who thrives in challenging environments? Do you aspire to revolutionize an industry? If your strength lies in prioritizing tasks and communicating effectively, then this role could be your next great adventure.As a Quality Assurance Engineer, you will collaborate with a fast-paced team of engineering experts to address quality assurance challenges for customized parts. You will also assist the Senior Director in developing our quality systems in line with corporate policies and AS9100 standards.

Feb 2, 2026

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Associate Director of Program Leadership & Management

Deciphera Pharmaceuticals, Inc.

Full-time|On-site|Waltham

Deciphera Pharmaceuticals is excited to invite applications for the role of Associate Director of Program Leadership & Management. In this pivotal position, you will provide exceptional leadership and strategic direction to our Development and Commercial Program Teams. Collaborating closely with the Program Lead, you will be instrumental in advancing programs from early to late-phase clinical development and lifecycle management. The ideal candidate will exhibit a comprehensive understanding of drug development, thrive in ambiguous situations, and possess outstanding communication skills to foster effective collaboration within program teams and across the organization.This role demands a high level of cross-functional teamwork, engaging with both internal and external partners. You will be responsible for leading daily program management activities, including the formulation and implementation of the program's Integrated Development Strategy. A deep understanding of overall program strategy and critical path activities, as well as risk identification and mitigation planning, is essential.Key ResponsibilitiesStrategic Partnership with the Program Lead (50%)Collaborate with the Program Lead to develop and execute strategic, integrated development plans through effective leadership of Program Teams.Provide clear guidance on product development requirements to align with the expectations of external customers and business stakeholders.Monitor program progress and related KPIs, identifying gaps and risks while offering strategic recommendations.Support the execution and ongoing reassessment of development strategies in line with the overall corporate strategy.Operational Excellence Across Program Teams (50%)Facilitate program team meetings to ensure productive and efficient discussions.Ensure timely and clear communication of program strategies and progress to relevant stakeholders.Coordinate the integration of sub-teams to enhance the effectiveness of Program Teams.

Nov 17, 2025

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Associate Director, CMC-Pharma Product Group

AbbVie Inc.

Full-time|On-site|Waltham

Join AbbVie as an Associate Director in our CMC-Pharma Product Group, where you will play a pivotal role in leading cross-functional teams to drive the development and manufacturing of high-quality pharmaceutical products. Your expertise will be crucial in ensuring compliance with regulatory standards and enhancing our product portfolio.

May 1, 2026

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Director of Supply Chain Operations at elevatebio | Waltham

elevatebio

Full-time|On-site|Waltham, Massachusetts, United States

Role Overview elevatebio is hiring a Director of Supply Chain Operations in Waltham, Massachusetts. This leadership role guides the strategic planning and daily execution of supply chain activities. The position focuses on building efficient processes, maintaining operational integrity, and supporting the company's mission in biotechnology. Key Responsibilities Lead supply chain strategy and initiatives across the organization Work closely with teams from different functions to optimize workflows Drive improvements in productivity and process efficiency Ensure quality and reliability throughout all supply chain operations Location This role is based in Waltham, Massachusetts, United States.

Apr 16, 2026

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Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)

Oruka Therapeutics

Full-time|$175K/yr - $200K/yr|Hybrid|Waltham, Massachusetts, United States

About Us:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing innovative biologics aimed at revolutionizing the treatment of chronic skin disorders. Our mission is to empower patients suffering from conditions such as plaque psoriasis by providing opportunities for significant disease clearance with minimal dosing frequency, potentially just once or twice a year. Leveraging a unique portfolio of advanced antibodies engineered by Paragon Therapeutics, we target the fundamental mechanisms contributing to plaque psoriasis and other dermatologic and inflammatory conditions. Learn more about our vision at www.orukatx.com.As we expand our core team, we are seeking passionate professionals who aspire to be part of a transformative journey, not just a job. If you are eager to make a positive impact and contribute to a vibrant, inclusive company culture, we want to hear from you.Job Title: Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)Location: Hybrid – Waltham, MA, with a requirement to be in-office 3 days a week.Position Overview:We are looking for a dynamic and skilled leader in Manufacturing Science and Technology (MSAT) to spearhead downstream late-stage and pivotal optimization, scale-up, and transfer of manufacturing processes. In this role, you will be responsible for process development, troubleshooting production challenges, data analysis, and ensuring adherence to regulatory standards to uphold product quality. The successful candidate will play a critical role in late-stage drug substance manufacturing and process validation activities to support BLA submissions. This position requires adaptability in a fast-paced environment, along with the ability to draft high-quality reports, finalize source documents, and actively participate in regulatory submissions. Join us as a vital member of a growing team dedicated to advancing best-in-class biotherapeutics.

Mar 30, 2026

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Associate Director of Financial Planning & Analysis

Crescent Biopharma

Full-time|On-site|Waltham, MA

The Associate Director of Financial Planning & Analysis at Crescent Biopharma is based in Waltham, MA. This role plays a key part in shaping financial planning at both the corporate and program levels, with a focus on budgeting and forecasting. Role overview This position partners with teams across the company, including R&D and Program Management. The Associate Director helps guide financial decisions that support Crescent Biopharma’s strategic goals and ongoing projects. What you will do Lead corporate and program-level budgeting and forecasting processes Collaborate with cross-functional teams to provide financial insight and analysis Support strategic planning by delivering accurate financial data and recommendations Location This role is located in Waltham, MA.

Apr 21, 2026

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Associate Director of Statistical Programming - Permanent Hybrid Role

ClinChoice

Full-time|Hybrid|United States

Are you looking for an opportunity to work closely with a single sponsor while benefiting from the stability and growth opportunities provided by a global CRO? Join our team at ClinChoice, where we believe it's the best of both worlds. ClinChoice is actively seeking an Associate Director of Statistical Programming for a permanent position in a hybrid work model. This role offers a unique chance to lead crucial statistical strategies within a vibrant and fast-paced environment. This position is hybrid, preferably requiring candidates to travel to our client’s location in Waltham, MA. We are looking for a seasoned Associate Director of Programming to spearhead programming initiatives, develop scalable processes, and guarantee the delivery of high-quality outputs for regulatory submissions.

Feb 5, 2026

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