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.

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.

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 197861 in all correspondence.