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
