Quality Assurance Manager, GCP at Sobi | San Diego

SobiSan Diego

On-site Full-time

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Experience Level

Experience

Qualifications

Required Qualifications:University degree in Life Sciences or a related field. A minimum of 5 years of experience within the pharmaceutical industry, specifically in Clinical Quality Assurance or operational clinical trial conduct, with GCP audit and/or Quality Assurance experience. Technical Skills:In-depth knowledge of applicable ICH GCP guidelines, industry best practices, and FDA, EMA, and ROW regulatory requirements. Understanding of quality assurance principles and practices. Documented education and experience in QA systems, with a preference for auditing experience. Soft Skills:Detail-oriented with a results-driven approach. Exceptional interpersonal and communication skills.

About the job

Overseeing quality assurance and design activities related to GCP/GCLP.
Providing guidance and support on GCP/GCLP and GPP-related activities throughout Sobi, including audits, inspections, and risk assessments associated with BLA/NDA/IND/CTA submissions globally.
Facilitating the collection of data necessary for the audit program risk assessment.
Supporting clinical study-related quality activities across Sobi.
Ensuring the qualification of global and local ESP in GCP regulated areas according to Sobi procedures.
Collaborating with relevant stakeholders across the Sobi organization.

Key Responsibilities:

Manage the GCP audit process to ensure excellence throughout the audit lifecycle.
Assess and approve GCP deviations and related CAPAs from a quality perspective.
Prepare regular status reports on audits, trending deviations, and CAPAs to uphold quality oversight.
Contribute to GCP audit risk assessments according to SOPs.
Actively engage with cross-functional teams on GxP and Quality requirements, ensuring proper qualification of GCP service providers.
Serve as the QA representative during GCP inspections and promote a continuous quality mindset across Sobi.
Develop and review GCP QA-related processes under the global framework.

About Sobi

At Sobi, we embrace diversity and encourage applicants from all backgrounds. We believe that innovative therapies can improve lives, and our team is the heart of our mission. We are dedicated to the development and delivery of therapies that enhance the lives of individuals with rare diseases. Our dynamic and collaborative culture fosters creativity and teamwork, making every day at Sobi rewarding. Here are just a few reasons to join our team:Competitive compensation. Generous time off policy. Opportunities for professional development through conferences. Commitment to work-life balance. Supportive, team-oriented environment.

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