Job Description:
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
