Innovative BioPharmapany – Senior QA Specialist
OverviewThis role provides Quality Assurance (QA) oversight for externally manufactured pharmaceutical products. The position ensures thatmercial bulk and finished products are manufactured, tested, released, and distributed in fullpliance with cGMP and global regulatory requirements. A key focus is managing and influencing external contract manufacturers while maintaining high-quality standards. Occasional travel may be required.
Key Responsibilities:Vendor & Product Quality Oversight
1. Serve as the primary QA contact for assigned products within global and international quality operations.
2. Build and maintain strong working relationships with contract manufacturing sites.
3. Lead quality‑related discussions with external partners, including topics such as deviations, OOS results,plaints, change controls, documentation, and processes.
4. Drive continuous improvement initiatives and ensure timelypletion of investigations, CAPAs, and quality actions.
Documentation &pliance
5. Review and approve master batch records and executed batch records for GMP and regulatorypliance.
6. Oversee and manage change controls, including initiation, QA assessment, tracking, and escalation.
7. Support and approveplaint investigations associated with external vendors.
8. Review and negotiate contractor documentation such as validation protocols/reports, deviation reports, and OOS investigations.
9. Lead or contribute to Annual Product Quality Reviews.
Quality Systems & Audits
10. Draft, review, and negotiate Quality Agreements with external contractors.
11. Participate in internal self‑inspections and external audits of CMOs and distributors.
12. Maintain QA documentation, logs, and databases.
13. Support regulatory inspections (, FDA, EMA).
14. Contribute to the development and maintenance of Pharmaceutical Quality Systems, SOPs, policies, and standards.
Required Skills &petencies
15. Strong knowledge of global cGMP/GDP regulations (US, EU, international).
16. Ability to balance business needs with robust scientific and quality decision‑making.
17. Excellent analytical and problem‑solving skills.
18. Strong relationship‑building skills to influence both internal and external stakeholders.
19. Effectivemunication, organisational, and project‑management abilities.
20. Proficiency with standardputer applications.
Qualifications & Experience
21. Bachelor’s degree (or equivalent) in a scientific discipline.
22. 5+ years of QA experience within the pharmaceutical industry.
23. Solid technical understanding of pharmaceutical manufacturing, QC, QA, and regulatory environments.
24. Experience supporting FDA/EMA inspections.
25. Proven experience working with external manufacturers or overseeing contract manufacturing operations.
#4770814 - Alex Speakman