QA Specialist

The QA Specialist will play a critical role in supporting External Quality Assurance Operations for late-stage programs (gene therapy), ensuring compliance with company procedures, Quality Agreement, and regulatory requirements.  This role will be responsible for reviewing and approving internal and external quality events, batch records, and notifications.  The ideal candidate will have strong attention to detail, a collaborative mindset, and a solid understanding of GMP principles in a pharmaceutical or biotech manufacturing environment.

Responsibilities :

Deviation Management :

Review and assess internal and external deviations related to manufacturing, and testing.

Ensure thorough root cause analysis and effective CAPA implementation.

Collaborate with stakeholders to drive timely closure and continuous improvement.

On-Site QA Operations (when necessary, at Contract Organization) :

Perform executed batch record review ensuring completeness, accuracy, and compliance with regulatory expectations.

Provide real-time QA support during manufacturing and aseptic processing operations, including oversight of critical steps and data integrity verification.

Change Control & Notifications :

Review and approve change controls and notifications, ensuring appropriate risk assessments and impact evaluations are conducted.

Ensure changes are implemented in a controlled and compliant manner, aligned with internal program milestones and regulatory commitments

Cross-Functional Collaboration :

Partner with Manufacturing, MS&T, QC, Regulatory Affairs, and Supply Chain to ensure alignment on quality expectations and timely issue resolution.

Continuous Improvement :

Contribute to the development and refinement of QA procedures, templates, and best practices tailored to support GMP operations.

Identify and implement process improvements to enhance compliance and operational efficiency.

Requirements / Qualifications :

Bachelor’s degree in a scientific discipline (e.g., Biology, Biochemistry, Biotechnology, Engineering) or equivalent experience.

8+ years of relevant experience in a GMP-regulated environment, preferably with biologics or gene therapy products.

Experience with Quality oversight of contract manufacturing organization (CMO).

Strong understanding of cell and gene therapy manufacturing processes, including aseptic techniques and plasmid production.

Experience with risk assessments, batch record review and change control using Veeva / TrackWise Quality System.

Strong knowledge of root cause analysis (RCA) tools with experience leading complex investigations.

Familiarity with regulatory requirements (FDA, EMA, ICH) for advanced therapy medicinal products (ATMPs).

Excellent communication, organizational, and analytical skills.

Ability to work independently and collaboratively in a dynamic, fast-paced environment.