QC Operations Manager

Talentmark Limited; Hatfield; On-site; GBP 65,000 - 90,000; Full time

Job summary

Talentmark Limited in Hatfield, UK seeks a QC Operations Manager to oversee QC product testing, ensure GMP compliance, and lead the QC team to meet tight lead times.

The role requires a science degree, extensive GMP QA experience, and proven people management skills to drive investigations, CAPAs, change control, and continuous improvement across laboratories and external contract labs.

Qualifications

• Educated to degree level or above in a science discipline with significant experience in a QC Management role.
• Experience leading and approving QC testing in GMP pharmaceutical environments.
• Proven people management experience with analytical teams.
• Strong understanding of GMP, QA, systems, and regulatory expectations.

Responsibilities

• Approve QC testing on bulk and finished product in line with GMP guidance.
• Authoring, checking or approval of SOPs, LBPs, spreadsheets, methods and reports.
• Maintain SOP coverage for all lab processes and calibration/maintenance of equipment.
• Lead investigations for OOS/OOT results and ensure timely CAPA closure.
• Manage direct reports and performance reviews, including training QC staff.
• Coordinate testing for EU importation and liaise with contract laboratories.
• Support audits and inspections and participate in change control and continuous improvement.
• Plan day-to-day QC activities and develop staff capabilities.

Skills

QC Management

GMP Knowledge

People Management

Quality Assurance

Data interpretation

Education

Science degree or above

Job description

Talentmark are recruiting for a QC OperationsManager

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

Role:

This role is responsible for the oversight of QC product testing (bulk and finished product), incoming goods testing and ensuring that all materials/bulk and finished product that require testing by the laboratory are done so according to agreed specifications and procedures and within agreed lead times.

Key duties will include:

• To approve QC testing conducted on bulk product, stability and finished product and approve or reject starting materials or packaging component in accordance with Good Manufacturing Practices.
• Authoring, checking or approval of documentation: SOP’s, LBPs, spreadsheets, methods, reports and protocols to ensure they are in conformance with Marketing or Clinical Trial Authorisations and / or regulatory expectations.
• Ensuring that all laboratory processes and equipment are covered by SOPs andensure that all equipment is covered by maintenance and calibration procedures.
• Leadinglaboratory investigations, including those related to OOS or OOT analytical results, ensuring they are investigated according to the agreed SOP and that any CAPAs are completed to agreed timelines.
• To manage all direct reports including any contractors to ensure that regular 1:1 meeting take place and that Job Descriptions, Objectives and performance reviews are up to date and completed on time.
• To ensure efficient planning of all day to day activities conducted by the QC analysts and train staff for the QC functions.
• To coordinate and support testing for EU importation, ensuring that a good working relationship is maintained with the contract laboratories and any issues/deviations are resolved.
• To support internal and external audits processes and audit schedules as appropriate andsupport the preparation and hosting of competent authority inspections.
• To support the implementation of change control activities and contribute to QC laboratory continuous improvement programme.

Your Background:

• Educated to degree level or above in a science discipline with significant previous experience in a QC Management role.
• Experience of leading and approving QC testing in GMP Pharmaceutical environment.
• Established people management experience and proven experience of directly managing analytical teams.
• Extensive knowledge of Quality Control, Quality Assurance, Quality Systems, GMP, Regulatory Compliance and manufacture and packaging of pharmaceutical products.
• Good technical and scientific judgement and the ability to interpret complex data and present key findings.
• Demonstrated Knowledge, understanding and application of GMP Guidelines and Regulations.

It is essential that applicants hold entitlement to work in the UK.