QC Operations Manager – GMP Pharma Leader

Talentmark; Hatfield; On-site; GBP 60,000 - 90,000; Full time

Job summary

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

This role oversees QC product testing (bulk and finished product), incoming goods testing and ensures testing is completed to agreed specifications and lead times. You will lead the QC team, author and approve SOPs, manage investigations (OOS/OOT) and CAPAs, and support audits and regulatory inspections.

Qualifications

• 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.

Responsibilities

• Approve QC testing conducted on bulk product, stability and finished product and approve or reject starting materials or packaging component in accordance with GMP.
• Authoring, checking or approval of documentation: SOPs, LBPs, spreadsheets, methods, reports and protocols to ensure compliance with regulatory expectations.
• Ensure that all laboratory processes and equipment are covered by SOPs and that all equipment is maintained and calibrated.
• Lead laboratory investigations, including OOS or OOT results, ensuring investigations and CAPAs meet timelines.
• Manage all direct reports including contractors, ensure 1:1 meetings, up-to-date job descriptions and performance reviews.
• Plan day-to-day QC analyst activities and train staff for QC functions.
• Coordinate testing for EU importation and maintain good relations with contract laboratories.
• Support internal and external audits and competent authority inspections; assist with change control and continuous improvement.

Skills

QC Testing Leadership

People Management

Data interpretation

GMP Knowledge

Education

Bachelor's degree in science

Job description

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

This role oversees QC product testing (bulk and finished product), incoming goods testing and ensures testing is completed to agreed specifications and lead times. You will lead the QC team, author and approve SOPs, manage investigations (OOS/OOT) and CAPAs, and support audits and regulatory inspections.