Lead - Quality Control And Quality Assurance

Role & responsibilities

• Lead and oversee Quality Assurance and Quality Control functions at the site.
• Ensure compliance with GMP, regulatory requirements, and quality standards.
• Drive site-wide Quality Management Systems, CAPA, deviations, change controls, OOS/OOT, investigations and validation.
• Lead and coordinate regulatory inspections, customer audits and compliance activities.
• Ensure continuous USFDA inspection readiness and effectively manage regulatory audits.
• Provide strategic quality leadership and ensure product quality and patient safety.
• Lead, mentor and develop the QA/QC team.
• Collaborate with Manufacturing, Engineering, R&D and Regulatory Affairs teams to resolve quality and compliance issues.
• Drive continuous improvement and strengthen the site's quality culture.

Preferred candidate profile

• 15+ years of relevant experience in pharmaceutical manufacturing.
• Strong and balanced exposure to both QA and QC functions.
• Candidates from API / Bulk Drugs / Pharma Manufacturing backgrounds are preferred.
• Strong experience in USFDA audits and regulatory inspections.
• Excellent knowledge of GMP and Quality Management Systems.
• Proven experience in team leadership and quality function management.
• M.Sc. / Ph.D. in Chemistry, Pharmaceutical Sciences or a relevant discipline.

Interested candidates can apply on [email removed] or only calls on [phone removed].