Senior Quality Manager

Senior Quality Manager

My client is seeking an experienced Senior Quality Manager to provide strategic and operational leadership for Quality Assurance activities at a regulated pharmaceutical manufacturing site. This role is critical to ensuring products are manufactured, tested, and released in full compliance with global regulatory expectations while supporting long-term site and business objectives.

Key Responsibilities

• Provide oversight of core QA operations, including IPQA, validation, training, document control, batch certification, and material release.
• Ensure ongoing compliance with cGMP, ICH, FDA, EMA, and other global regulatory requirements.
• Act as a key quality representative during regulatory inspections, customer audits, and supplier audits.
• Review and approve quality documentation such as SOPs, protocols, validation plans, and reports.
• Drive data integrity, right-first-time performance, and robust quality decision-making across operations.

• Develop and deliver QA objectives aligned with the site long-range plan and overall quality strategy
• Partner closely with Manufacturing, Regulatory Affairs, R&D, and Supply Chain to support commercial production, new product introductions, and lifecycle management.
• Lead risk assessments and ensure proactive mitigation of quality and compliance risks.

• Lead, coach, and develop a multi-level QA organisation including managers, supervisors, associates, and contractors.

Requirements

• Proven leadership experience in Quality Assurance within a regulated pharmaceutical manufacturing environment.
• Strong working knowledge of global regulatory standards (FDA, EMA, ICH, cGMP).
• Demonstrated success leading inspections and audits.
  
  
• Excellent communication and stakeholder-management skills, with the ability to influence at all levels.
• Strong analytical, problem-solving, and decision-making capabilities.
• Ability to balance compliance, operational efficiency, and business priorities in a fast-paced environment