We are looking for an experienced and dynamic Manager / Senior Manager Corporate Quality Assurance to strengthen our Corporate QA function and support quality governance across manufacturing sites and external partners.
The ideal candidate should have 13-18 years of experience in the pharmaceutical industry, with robust exposure to European regulatory requirements, EU GMP, regulatory inspections/audits, Quality Management Systems and people management. Experience in handling or supporting European customer/regulatory audits and working in a corporate/CQA environment will be preferred.
Role & responsibilities
- Lead Corporate QA activities and ensure effective implementation of GMP and Quality Management Systems across sites.
- Manage European regulatory and EU GMP compliance requirements.
- Lead/support European regulatory, customer and GMP audits, including audit preparation, responses and CAPA closure.
- Drive QMS elements including Deviation, CAPA,
Change Control, OOS/OOT, QRM, PQR/APQR and Supplier/CMO Quality Management.
- Provide corporate QA oversight and support quality governance across manufacturing sites.
- Lead, mentor and develop the QA team and effectively manage cross-functional stakeholders.
Preferred candidate profile
- 1318 years of pharmaceutical QA experience.
- Currently at Manager/Senior Manager level with demonstrated people-management experience.
- Strong European regulatory / EU GMP exposure.
- Hands-on European audit-facing experience is essential/preferred.
- Corporate QA (CQA) exposure preferred.
- Excellent communication, leadership, analytical and stakeholder-management skills.
Interested candidates may share their updated CV with relevant European audit and CQA experience.