Senior Scientist - Quality Assurance Function Lead

About the role

The QAFL serves as a site-level Quality Compliance and Inspection Leader, with primary accountability for regulatory and client inspection readiness, Quality System compliance, and sustained GMP control. The role acts as the primary QA focal point for regulators and clients, while ensuring effective oversight of project quality execution, deviation management, and continuous improvement of the Quality Management System (QMS).

Key responsibilities

• Lead and manage the full lifecycle of regulatory authority and client inspections/audits, including pre-inspection readiness, on-site inspection hosting, and post-inspection activities

• Act as the primary site focal point for regulatory authorities and client audits, ensuring consistent, compliant, and confident representation of the site Quality System and GMP operations

• Own and lead the site Self-Inspection Program, including establishing risk-based self-inspection strategy, developing annual inspection plans, and coordinating cross-functional self-inspection activities

• Perform systematic trend analysis of audit, inspection, self-inspection, deviation, and CAPA data to identify recurring compliance issues and systemic weaknesses

• Monitor global and local regulatory requirements and inspection trends (e.g. FDA, EMA, HSA, PIC/S, ICH)

• Act as the primary quality liaison for clients, responsible for daily quality communication, conducting quality meetings, and providing client audit support

• Oversee and track project-related quality events, including deviations, change controls, and CAPAs

• Monitor GMP production batch progress and coordinate cross-functional resources to support on-time, compliant execution

• Serve as a trusted compliance advisor to site leadership and functional teams on inspection readiness, regulatory and audit risks, and Quality System enhancements

• Perform other compliance-related duties and special assignments as directed by management

About you

• Bachelor's degree or above in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related discipline

• 10–15 years (or level-appropriate) experience in QA Compliance, Quality Systems, or Regulatory Compliance

• Proven experience hosting and managing regulatory inspections (FDA, EMA, HSA, PIC/S) and client audits

• Demonstrated ownership of site self-inspection programs

• Hands-on experience managing CAPAs, audit/inspection responses, and regulatory commitments

• Strong knowledge of GMP regulations: FDA 21 CFR 210/211, EU GMP, PIC/S, ICH Q7/Q9/Q10

• Solid understanding of QMS, inspection readiness, and risk-based compliance approaches

• Strong inspection hosting, communication, and stakeholder-management skills

• Ability to identify systemic issues and drive sustainable improvements

• Excellent technical writing skills (audit reports, inspection responses, CAPAs)