Quality Operations Manager

Talentmark are recruiting for a Quality Operations-Manager, to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, on a permanent basis.

Role:

This role is responsible for-Quality Operations and Quality Assurance activities, ensuring GMP compliance and quality system support for the manufacture, packaging, testing, storage, and distribution of marketed drug products.
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Key duties will include:

• Ensure quality system procedures and processes meet corporate, regulatory, and industry requirements and promote site adherence to them.
• Support site compliance activities, including implementation of new GMP requirements and inspection readiness programs.
• Support and (where required) lead Quality Operations planning and provide QA oversight for QC and Production activities to enable timely batch review, release, and distribution.
• Perform batch review of site and non-site manufactured batch records, as required.
• Monitor and report Quality Management System performance metrics and KPIs. Input and lead Quality Management Review meetings (as required.)
• Represent Quality Operations during regulatory inspections, customer audits, and third-party audits and support internal and external audit programs.
• Lead the Product Quality Review (PQR) program, including trend analysis and reporting.
• Author, review, and approve SOPs and other quality documentation such as PQRs, deviations, complaints, investigations, CAPAs, change controls, and qualification/validation documentation.
• Maintain and enhance the TrackWise Quality Management System, ensuring compliance with GxP and electronic records requirements.
• Deliver GMP and quality systems training, coaching, and mentoring to site personnel.

• Educated to degree level or above in a science discipline with extensive previous experience in a Quality Management or Quality Assurance leadership role within the pharmaceutical industry.
• Extensive knowledge of Quality Assurance, Quality Systems, GMP, GDP, and pharmaceutical manufacturing and packaging processes.
• Experience with overseeing, maintaining and improving Quality Management Systems.
• Strong understanding of global GMP regulations and guidelines, with the ability to interpret, implement, and maintain compliance requirements.
• Proven ability to build effective relationships and collaborate across functions, sites, affiliates, and external partners.
• Strong communication and influencing skills, with the ability to engage stakeholders at local, regional, and global levels.