Quality Operations Manager

Talentmark; Welwyn; On-site; GBP 75,000 - 95,000; Full time

Job summary

Talentmark in Hatfield, Hertfordshire is seeking a Quality Operations Manager to lead QA and QA activities, ensuring GMP compliance across manufacturing, packaging, testing, storage and distribution of marketed drug products.

You will oversee Quality Management System performance, lead audits and inspections, author SOPs, and mentor site personnel to maintain regulatory readiness and product quality.

Qualifications

• Degree or higher in a science field with QA leadership experience.
• Extensive knowledge of QA, GMP, GDP and pharmaceutical manufacturing processes.
• Experience maintaining Quality Management Systems.
• Ability to interpret global GMP regulations and ensure compliance.
• Proven ability to collaborate across functions and external partners.
• Strong communication and influencing skills.

Responsibilities

• Lead Quality Operations and QA activities to ensure GMP compliance.
• Provide QA oversight for batch review, release, and distribution.
• Maintain and enhance the Quality Management System and TrackWise.
• Lead and participate in regulatory inspections, audits, and internal reviews.
• Develop and implement SOPs, deviations, CAPAs, and change controls.
• Deliver GMP training and mentorship to site personnel.

Skills

Quality Assurance leadership

GMP knowledge

GDP knowledge

Quality Management Systems

Regulatory inspections

Stakeholder engagement

Education

Bachelor's degree in science

Tools

TrackWise

Job description

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

Role

This role is responsible forQuality 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.

Your Background:

• 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.