QC Operations Manager

Talentmark; Welwyn; On-site; GBP 70,000 - 90,000; Full time

Job summary

Talentmark is recruiting a QC Operations Manager to oversee QC product testing (bulk and finished product), incoming goods testing, and ensure testing aligns with specifications and lead times. The role requires degree-level science background, GMP QA knowledge, and proven people management within analytical labs.

The position will involve approving QC testing, authoring SOPs and CAPA-led investigations, and coordinating audits.

Qualifications

• Educated to degree level or above in a science discipline.
• 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.

Responsibilities

• Approve QC testing on bulk product, stability and finished product.
• Authoring, checking or approval of SOPs, LBPs, spreadsheets, methods and reports.
• Ensure laboratory processes and equipment are covered by SOPs and calibration procedures.
• Lead laboratory investigations including OOS/OOT, ensuring CAPAs are completed on time.
• Manage direct reports and contractors; conduct 1:1 meetings and performance reviews.
• Plan day-to-day QC analyst activities and train staff for QC functions.
• Coordinate testing for EU importation and liaise with contract laboratories.
• Support internal and external audits and authority inspections.
• Support change control implementation and QC continuous improvement.

Skills

People management

QC testing leadership

GMP expertise

Quality systems

Regulatory compliance

Analytical skills

Education

Science degree

Job description

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, reportsand 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.