Quality Control Lead – Raw Materials & Packaging

About the role

The Quality Control Lead is responsible for overseeing all QC activities related to raw materials and primary packaging materials in a pharmaceutical manufacturing environment. This senior position ensures timely testing, approval, and release of materials while maintaining compliance with GMP, pharmacopeial standards, and regulatory requirements across multiple sites.

Key responsibilities

• Lead QC activities for raw materials (APIs, excipients, solvents), ensuring effective sampling, testing, review and approval against approved specifications and pharmacopeial standards (USP, EP, BP, JP).
• Review and approve raw material test results, Certificates of Analysis and analytical data, applying appropriate testing strategies such as full testing, reduced testing or skip‑lot where applicable.
• Maintain GMP, data integrity (ALCOA+) and site SOP compliance, keeping documentation inspection‑ready for material testing and release.
• Act as Subject Matter Expert during regulatory inspections and audits, supporting risk assessments related to material quality and supply continuity.
• Lead investigations for out‑of‑specification, out‑of‑trend and deviation events, assess impact on in‑process and finished products, and drive timely CAPA implementation.
• Support change control activities for suppliers, specifications and analytical methods, and collaborate with QA, Procurement, Supply Chain, Warehouse and Regulatory Affairs.
• Coach, develop and allocate workload for raw material analysts and specialists, identifying training needs and ensuring competency development.
• Provide technical oversight across all sites, harmonising QC performance and driving improvement initiatives to enhance quality, testing efficiency and cost optimisation.

Required profile

• Proven experience leading QC teams in a pharmaceutical or related manufacturing setting.
• Strong ability to coach, develop and allocate work for analysts while ensuring GMP compliance.
• Experience conducting supplier qualification, vendor audits and supporting regulatory inspections.
• Capability to manage investigations, change control and CAPA processes effectively.

Required skills

• GMP compliance
• Pharmacopeial standards (USP, EP, BP, JP)
• Analytical testing and data interpretation
• Data integrity principles (ALCOA+)
• Regulatory inspection support
• Risk assessment
• CAPA implementation
• Change control management