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