Pharmaceuticals & Biotechnology
7 Jul
Quality Site Head
About the Role
We are seeking a high-caliber Executive Quality Leader to take ultimate accountability for our manufacturing site’s Quality Operations. You will architect, govern, and continuously elevate a robust, documented Quality Management System (QMS) ensuring all pharmaceutical products are manufactured and supplied in flawless compliance with cGMP, international standards, and national regulatory guidelines. As a core member of the leadership team, you will act as the final site authority on product disposition, compliance strategy, and operational risk management.
Key Responsibilities
Batch Release & Technical Authority: Hold ultimate regulatory accountability for the final release or rejection of all materials and finished products, serving as the final decision-maker on complex deviations, OOS/OOT investigations, or potential rework procedures.
Audit & Regulatory Frontline: Lead the preparation, hosting, and successful execution of all health authority inspections and external partner audits; oversee the site's annual self-inspection matrix and direct timely CAPA closeouts.
Validation & Qualification Governance: Approve and oversee all site validation master plans, ensuring engineering, facility, process, cleaning, utility, and computerized system validation (CSV) workflows strictly adhere to global guidelines.
Financial & Resource Stewardship: Own and manage the Quality Operations annual OPEX and CAPEX budgets, ensuring optimal resource allocation and efficient cost-of-quality tracking.
Risk & Change Governance: Drive the site’s Change Control panel and Quality Risk Management (QRM) policies, reviewing and signing off on all high-impact changes, technical complaints, and site recall strategies.
Executive Metrics & Leadership: Establish and track site Quality KPIs, reporting performance trends directly to corporate executive councils while leading, mentoring, and building technical competency for a team of 5 senior QA/QC managers.
What We Are Looking For
Experience: 15+ years of heavy operational experience within pharmaceutical manufacturing plants, with at least 7 to 10 years spent in high-level Quality leadership roles managing QA, QC, and Validation functions.
Technical Portfolio: Extensive background across diverse dosage forms (solids, liquids, sterile/non-sterile production loops) coupled with deep, uncompromised command of local regulatory frameworks and international standards (FDA expectations, EU GMP, WHO, and ICH guidelines).
Qualifications: Bachelor’s degree in Pharmacy, Chemistry, or Chemical Engineering is required. A Master's degree (MBA, Industrial Pharmacy, or Quality Systems) along with Lean Six Sigma or Lead Auditor certifications is highly desirable.
Leadership Presence: A strategic decision-maker with exceptional crisis management instincts, strong budget-handling capabilities, and a proven track record of driving a robust quality culture across large industrial operations.