Role: Senior Quality Assurance and Compliance Specialist
Reporting to: Head of Quality Assurance and Compliance
Role and responsibilities:

Own and continuously improve the Quality Management System, driving updates and efficiencies rather than simply supporting them.
Lead the management of customer complaints and other non-conformances, including root cause analysis and CAPA ownership through to close-out.
Lead change control management, ensuring changes are appropriately assessed, documented and implemented in line with regulatory requirements.
Own the development, review and updating of policies and standard operating procedures, ensuring they remain current and fit for purpose.
Act as a key point of contact for customer questionnaires and health, safety, security, environment, quality and regulatory queries relating to products and services.
Lead the internal audit programme, including risk assessment, scheduling, fieldwork, reporting and follow-up, and take ownership of audit outcomes.
Lead and facilitate quality and HSSEQ audits, including hosting external and regulatory audits where required.
Partner with the Q&C team and wider business to ensure the client meets all regulatory obligations across its products, services and industries served, providing subject matter expertise where needed.
Mentor and support the development of other Q&C team members, sharing knowledge and best practice.
Deputise for the Head of Quality Assurance and Compliance as required.
Take on additional responsibilities assigned by Management from time to time.

Experience & competencies:

Relevant third-level qualification in a science, quality or related discipline.
Minimum 5+ years' experience in a quality assurance and/or compliance role within pharma or an allied regulated industry, ideally including some experience leading audits, projects or process improvements.
Strong working knowledge of quality management systems, deviations, CAPA, change control and root cause analysis.
Proven ability to manage multiple priorities and competing deadlines in a fast-paced regulated environment.
Confident liaising with and influencing external stakeholders including customers, suppliers and regulators.
Track record of building strong, collaborative working relationships across teams.
Experience supporting or mentoring junior colleagues, particularly within a Q&C function.
Excellent verbal, written and interpersonal communication skills, with the ability to present to and influence senior stakeholders.
Lean Six Sigma or similar process improvement qualification an advantage.
Proficient in the Microsoft package.

Quality Assurance Specialist