Manager II, Clinical Quality Assurance

Hello Tarsan!We appreciate your interest in the Manager II, Compliance position. Please take a moment to examine the details below. If this role aligns with your career aspirations, we encourage you to discuss your qualifications with your current manager and HR business partner. If everything aligns, we invite you to apply, and our Talent Acquisition team w…

Hello, and thank you for your interest in the Quality Compliance Manager II position at itcss! We encourage you to review the details below. If this role aligns with your career aspirations, please discuss with your current manager and HR business partner to see if your qualifications match. If all goes well, we invite you to apply, and our Talent Acquisition team will reach out for an interview to learn more about you.- Your Human Resources TeamAbout the Role:The Quality Compliance Manager II plays a crucial role in supporting the Product Quality Complaint program, ensuring all complaints are addressed in compliance with Good Manufacturing Practices (GMPs) and health authority regulations. This position will also support Annual Product Reviews and assist in various Quality Management System (QMS) areas as needed, such as audits, inspections, change control, document control, and corrective action and preventive action (CAPA).Key Responsibilities:Manage the product complaint program throughout its lifecycle, including:Initiating Product Complaint InvestigationsCollaborating with Call Center staff for complaint intakeFollowing up with complainants as neededParticipating in Weekly Product Complaint MeetingsDrafting response letters to complainantsReviewing and closing Product Complaint investigationsContributing data to Annual Product ReviewsPreparing monthly metrics and management presentationsSupporting regulatory inspections or partner audits as necessaryAuthoring, revising, or approving controlled documentsStay abreast of regulatory changes and proactively adjust systems and procedures to ensure compliance with company policies and regulations.Monitor and escalate product complaints appropriately, including expedited complaints.Foster strong relationships, cooperation, and alignment with internal Quality partners.Compile Annual Product Reviews, ensuring timely data submission from collaborating departments.Assist with product recalls or field alerts as needed.

About the Role The Compliance Manager II will collaborate closely with the Compliance Department to design, implement, and uphold a robust Compliance Program that fosters a company-wide ethos of ethics and compliance, while ensuring adherence to applicable regulatory standards including the Office of Inspector General (OIG) Guidance, U.S. Sentencing Guidelines, and Department of Justice guidance. As an integral member of a collaborative team, you will play a vital role in the continuous improvement of all facets of the Tarsus Compliance Program. Key Responsibilities: Lead the execution of the comprehensive transparency reporting process, ensuring compliance with federal and state reporting requirements by collaborating with internal stakeholders to facilitate accurate data collection and review, managing vendor relationships, conducting training sessions, and maintaining supporting systems for timely submissions. Ensure compliance with federal and state healthcare laws and regulations by monitoring regulatory changes and collaborating with internal teams to assess impacts, implement controls, and align with company policies. Develop and sustain reporting tools, dashboards, and outputs related to transparency reporting and operational compliance, ensuring high standards of data quality and accuracy. Partner with the Compliance Data Analytics Lead to support analytics initiatives and explore opportunities to leverage data analytics and emerging technologies, such as AI, to enhance processes and operational efficiency. Optimize and manage relationships with external vendors involved in transparency reporting and related systems, focusing on data quality, performance, and process enhancements. Assist the Compliance Officer with various projects and tasks as required. Provide continuous support for the company by addressing employee inquiries and concerns.

About the Role:The Quality Compliance Manager II plays a vital role in overseeing the Product Quality Complaint program, ensuring that all complaints are managed in strict adherence to Good Manufacturing Practices (GMPs) and the expectations of health authorities. This position will also contribute to the Annual Product Reviews and support various Quality Management System (QMS) areas as needed, such as audits, inspections, change control, document control, and corrective actions.Key Responsibilities:Manage the entire product complaint process from initiation to resolution, including:Initiating Product Complaint InvestigationsCollaborating with Call Center staff for complaint intakeDirectly following up with complainants when necessaryParticipating in weekly product complaint meetingsDrafting response letters for complainantsReviewing and closing product complaint investigationsContributing complaint data to Annual Product ReviewsPreparing monthly metrics and management review presentationsAssisting with regulatory inspections and audits, as requiredAuthoring and revising controlled documentsStay abreast of the regulatory landscape to proactively enhance systems and procedures for effective complaint management.Ensure proper monitoring and escalation of product complaints, including those requiring expedited attention.Foster effective collaboration and alignment within the Quality team and across internal partners.Compile and ensure timely delivery of data for Annual Product Reviews, including:Coordinating with contributing departmentsPreparing necessary product complaint metricsDelivering the final report on scheduleAssist with recalls or field alerts as necessary.Conduct mock recalls and support other Quality Management Systems, including Document Control, Change Control, and CAPA.Perform any additional duties assigned by department management.

Hello Tarsan,Thank you for your interest in this exciting opportunity! We encourage you to review the details below. If this role aligns with your career aspirations, we recommend connecting with your current manager and HR Business Partner to discuss how your skills and experiences match. If all is well, please submit your application, and our Talent Acquisition team will reach out to arrange an interview to learn more about you.- Your Human Resources TeamAbout the PositionWe are seeking a dedicated Manager II for Scientific & Medical Communications to spearhead our medical communications initiatives. You will report directly to the Senior Director of Scientific and Medical Communications and will collaborate extensively across all medical affairs functions. We are looking for a detail-oriented individual with exceptional project management skills who is analytical, innovative, and enjoys creating scientific content.Key ResponsibilitiesDesign and execute medical communication strategies, working collaboratively with cross-functional teams to ensure consistent messaging.Develop, review, and finalize external-facing medical content and educational resources in accordance with the medical communication strategy.Assist in generating posters and presentations for conferences both domestically and internationally.Oversee publication projects, including editorial assistance, article writing, quality assurance, and coordination of submission processes.Provide training and education on posters and presentations for medical congresses.Support medical information, congress activities, and advisory board initiatives.Manage project-related tasks concerning internal contracting and content review processes, including contracting and MLR.

Join Artech Information Systems LLC as a Compliance Consultant, where you will play a crucial role in ensuring our clients adhere to regulatory standards and internal policies. This position will challenge you to utilize your expertise in compliance frameworks and enhance our clients' operational integrity.

Join AbbVie, a global biopharmaceutical company, as a Tariff Classification Supervisor in our Global Trade Compliance team. In this vital role, you will oversee tariff classification operations, ensuring compliance with international trade regulations and optimizing import/export processes. Your expertise will help us navigate complex tariff systems and maintain the integrity of our supply chain.

Position OverviewJoin field.ai as the Director of Export Control and Technology Compliance, where you will play a pivotal role in establishing and leading our compliance framework for defense-adjacent and commercial technology initiatives. In this dynamic position, you will be responsible for the classification, protection, and access management of technical data, software, and systems in alignment with U.S. export regulations and government contract stipulations. This hands-on role requires strategic acumen and operational execution, collaborating closely with leadership across Engineering, IT, Legal, Human Resources, and Program teams to facilitate swift development while upholding rigorous compliance standards.

Join AbbVie, a global biopharmaceutical company, as a Tariff Classification Supervisor within our Global Trade Compliance team. In this pivotal role, you will oversee tariff classification processes, ensuring compliance with international trade regulations and optimizing our import and export activities. Your expertise will directly contribute to our mission of delivering innovative solutions to patients worldwide.

Thank you for your interest in the Accounts Payable Manager II position at itcss. If this role aligns with your career aspirations, we encourage you to discuss your qualifications with your current manager and HR Business Partner before applying. Our Talent Acquisition team is looking forward to learning more about you during the interview process.- Your Human Resources TeamAs the Accounts Payable Manager II, reporting to the Senior Director of Corporate Controller, you will spearhead the accounts payable operations, ensuring efficiency in vendor maintenance, purchase order processing, and invoice management. Ideal candidates are adept at handling multiple tasks in a dynamic environment and possess a keen attention to detail. Strong prioritization, problem-solving, and time management skills are essential, as well as the ability to meet deadlines. This role requires excellent communication skills, engaging with all departments within the organization.Key Responsibilities Include:Leading and managing the accounts payable teamOverseeing the creation of purchase orders from fully executed contracts in line with company policyFacilitating the processing of invoices for payment, including 2-way and 3-way matching, account coding, data entry, and approvals within the accounting systemAdministering weekly payment batches and handling ad hoc payments as requiredManaging the Concur system and travel policy coordinationActing as the administrator for company programs such as Uber and DoorDashOverseeing the credit card programProviding training on systems including NetSuite and ConcurMaintaining the vendor master file within NetSuite in collaboration with ProcurementReviewing invoices for proper documentation and approvals prior to paymentMonitoring the accounts payable inbox for purchase order requests and invoicesOffering customer service support to internal departments and vendors regarding accounts payable inquiriesMaintaining 1099 data for vendors and assisting with annual filingReconciling vendor statements and correcting discrepancies as necessary

As a pivotal member of our Quality Assurance team, the Manager II, Quality Assurance will report directly to the Associate Director of Quality Assurance. This crucial role entails the meticulous review and management of manufacturing deviations and laboratory out-of-specification (OOS) reports, along with the assessment of manufacturing-related change controls in alignment with Tarsus’ Quality Management System (QMS). The Manager II will also take charge of authoring Annual Product Reviews, interpreting and trending analytical data, approving Certificates of Analysis, reviewing manufacturing batch records, and determining product disposition.Key Responsibilities:Evaluate and authorize vendor change controls.Scrutinize vendor documents such as Master Batch Records and Master Packaging Records.Review product specifications for compliance.Assess and approve deviations and OOS reports.Conduct data analysis and trend evaluations.Author Annual Product Reviews to ensure product integrity.Revise and author Quality Assurance Procedures as necessary.Examine new master manufacturing records and process validation protocols.Review and approve test records and Certificates of Analysis.Evaluate executed manufacturing and packaging batch records.Complete batch record review forms for product disposition.Finalize product disposition forms and Certificates of Compliance.Engage in internal operations discussions.Collaborate with Tarsus’ manufacturing partners and testing laboratories.

Thank you for your interest in the Manager II, Clinical Quality Assurance position at itcss! We encourage you to explore the details below. If you believe this role aligns with your career aspirations, please discuss with your current manager and HR business partner to assess your qualifications. Should everything align, we invite you to apply, and our Talent Acquisition team will reach out to you for an interview. We look forward to getting to know you!- Your Human Resources TeamAbout the RoleAs the Manager II of Clinical Quality Assurance, reporting to the Director of Clinical Quality Assurance, you will play a pivotal role in overseeing clinical quality support and the management of the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) supplier qualification program.The ideal candidate will be instrumental in preparing the company for inspections, providing training, and ensuring compliance with current ICH GCP E6 guidance and relevant regulations.Key Responsibilities:Deliver daily clinical quality support and training to ensure compliance with regulatory requirements and internal policies.Manage GCP/GLP/GVP internal and supplier audits, including maintaining the qualification program's audit schedule within the Quality Management System (QMS).Conduct supplier audits and prepare reports as necessary.Compile audit responses and evaluate implementation evidence.Assist in the development of quality systems and processes in the Clinical Quality domain.Review and approve QMS records (deviations, CAPAs, change controls, etc.) for completeness and adherence to SOPs and regulations.Support remediation and corrective action plans, ensuring resolution of quality issues.Assist in reviewing Clinical Quality Management Plans (CQMPs) for trials and vendor performance.Manage clinical training curricula and assist in creating tools to track quality metrics.Support risk assessments and conduct periodic reviews of clinical trial systems (e.g., CTMS, TMF).Collaborate with Quality Management to maintain compliance with various standards.

We are seeking an experienced and detail-oriented Accounts Payable Manager II to join our dynamic finance team at TarsusRx. Reporting directly to the Senior Director of Corporate Controller, you will spearhead the accounts payable function, ensuring efficiency and accuracy in vendor maintenance, purchase order processing, and invoice management. Your ability to juggle multiple tasks in a fast-paced environment will be crucial. Strong attention to detail, effective prioritization, problem-solving capabilities, and time management skills are essential for success in this role. Additionally, excellent communication skills are required, as you will interact with various departments across the organization.Key Responsibilities:Lead and manage the accounts payable team, fostering a collaborative and productive work environment.Oversee the creation of purchase orders in compliance with company policies based on fully executed contracts.Coordinate invoice processing for payments, ensuring accurate 2-way and 3-way matching, account coding, data entry, and necessary approvals within the accounting system.Administer weekly payment batches, including ad hoc payments as necessary.Manage the Concur system and enforce travel policies throughout the business.Serve as the administrator for company programs such as Uber, DoorDash, and UnitedPassPlus.Oversee the credit card program and maintain the vendor master file in NetSuite in collaboration with Procurement.Review invoices for appropriate documentation and approval prior to payment.Monitor the accounts payable inbox for purchase order requests, invoices, and correspondence.Provide exceptional customer service and support to both internal departments and vendors regarding accounts payable inquiries.Maintain 1099 data for vendors and assist with annual filing requirements.Reconcile vendor statements and address discrepancies as needed.Support the accounts payable close process as part of the overall financial period close process.Contribute to SOX 404(b) compliance efforts, including maintaining accurate process documentation and audit-ready support for accounts payable activities.Assist with special projects as required.

Greetings, and thank you for your interest in the Manager II, Quality Assurance (Commercial) position at Tarsus Pharmaceuticals! If you believe this role aligns with your career aspirations, please engage with your current manager and HR Business Partner to discuss your qualifications. If all aligns, we encourage you to apply, and our Talent Acquisition team will reach out for an interview to learn more about you.- Your Human Resources TeamIn this role, reporting to the Associate Director of Quality Assurance, you will play a pivotal role in managing the review and processing of manufacturing Deviations and Laboratory Out of Specification (OOS) cases, as well as overseeing manufacturing-related Change Controls within Tarsus’ Quality Management System (QMS). Your responsibilities will also include authoring Annual Product Reviews, analyzing and trending analytical data, approving Certificates of Analysis, and conducting thorough reviews of manufacturing batch records and product disposition.Key Responsibilities:Approve Vendor Change ControlsAssess vendor documentation such as Master Batch Records and Master Packaging RecordsReview SpecificationsEvaluate and approve Deviations and OOS casesAnalyze and trend data for quality assuranceWrite Annual Product ReviewsDraft and revise relevant Quality Assurance ProceduresReview new proposed master manufacturing records and related process validation protocolsReview and approve Test Record Review Forms and Certificates of AnalysisOversee the review and approval of executed manufacturing and packaging batch recordsComplete Batch Record Review Forms for batch dispositionFinalize Product Disposition Forms and Certificates of ComplianceEngage in internal operations discussionsParticipate in meetings and discussions with Tarsus' manufacturing partners and testing laboratoriesAttributes for Success:Preferred Bachelor's Degree with over 8 years of experience in the Pharmaceutical IndustryMinimum of 5 years in Pharmaceutical Quality AssuranceMeticulous attention to detailProficient technical abilities across various platformsStrong knowledge of Microsoft Office, including charts and graphsASQ Certification is preferred

Join WithumSmithBrown as a Corporate Tax Manager, where you will play a pivotal role in overseeing and managing corporate tax compliance for a diverse portfolio of clients. In this dynamic position, you will leverage your expertise to develop strategies that ensure compliance with tax regulations while optimizing tax positions. Your analytical skills will be vital in identifying tax planning opportunities and providing guidance on complex tax matters.

Terran Orbital Corporation is hiring an Environmental, Health & Safety (EHS) Manager based in Irvine, CA. This role centers on building and maintaining a workplace where safety and sustainability come first. What you will do Oversee compliance with all environmental, health, and safety regulations relevant to the company’s operations. Develop and implement safety protocols to protect employees and the facility. Lead initiatives that foster a strong safety culture across the organization. Role focus The EHS Manager acts as a guide for the company’s safety efforts, ensuring that policies and practices support a safe and sustainable workplace. This position works closely with teams to promote awareness and adherence to safety standards.

Join our dynamic team at Able Services as a Facilities Technician II. In this role, you will be responsible for maintaining and repairing a variety of facility systems and equipment, ensuring a safe and efficient environment. If you have a passion for hands-on work and the ability to troubleshoot various mechanical and electrical systems, we want to hear from you!

Join AbbVie as a Marketing Manager I/II specializing in Surgical Eye Care, where you will play a pivotal role in driving our marketing strategies and executing innovative campaigns that resonate in the healthcare sector. Collaborate with cross-functional teams to enhance product visibility and ensure alignment with our business goals. Your expertise will be critical in analyzing market trends and consumer insights to develop impactful marketing initiatives.

Join our dynamic team at CRB as a Cost Control Analyst II, where your analytical skills will support the financial management of various projects. In this position, you will be tasked with creating and overseeing project labor and expense plans, utilizing accounting and project management systems to forecast costs, and ensuring the accuracy of billing and financial reports. The successful candidate will work closely with project teams to implement cost control practices and enhance financial outcomes.Key ResponsibilitiesDesign and oversee project labor and expense plans.Conduct cost forecasting using advanced accounting and project management tools.Ensure precise and timely processing of project and client billing.Perform thorough financial reviews of assigned projects.Engage regularly with the cost control team, Project Directors/Managers, and field personnel to reinforce financial protocols and ensure adherence to internal policies.