ResponsibilitiesThe OpportunityReporting to the Head of Quality Control, you will be responsible for the management and oversight of QC product testing, including bulk and finished products, incoming materials, stability programmes, and microbiological support activities.
You will play a critical role in ensuring all testing is completed to agreed specifications, procedures, and timelines while maintaining compliance with GMP regulations and industry standards. This is an excellent opportunity to join a highly regulated manufacturing environment where quality, continuous improvement, and patient safety are at the heart of everything.
Key ResponsibilitiesLead and oversee QC laboratory operations and testing activities.
Approve QC testing results for bulk, stability, and finished products.
Approve or reject incoming materials and packaging components in accordance with GMP requirements.
Author, review, and approve technical documentation including SOPs, analytical methods, protocols, reports, and laboratory documentation.
Ensure laboratory equipment is maintained, calibrated, and compliant.
Lead investigations relating to OOS (Out of Specification) and OOT (Out of Trend) results, ensuring effective CAPA implementation.
Manage, coach, and develop QC team members through regular performance management and training.
Coordinate analytical testing activities with third-party laboratories and contract testing partners.
Support change controls, method transfers, product quality reviews, audits, and regulatory inspections.
Drive continuous improvement initiatives across the laboratory function.
Ensure quality issues are escalated appropriately and resolved effectively.
RequirementsWhat We're Looking ForSignificant experience within Quality Control in a pharmaceutical manufacturing environment. Strong understanding of GMP, Quality Assurance, Quality Systems, and Regulatory Compliance.
Proven leadership and people management experience.
Experience managing laboratory investigations, deviations, CAPAs, and quality systems. Strong technical and scientific judgement with the ability to analyse complex data.
Excellent communication, presentation, and stakeholder management skills. Ability to build effective relationships across Quality, Production, Regulatory, and external partners.
Proficiency with Microsoft Office applications including Word, Excel, and PowerPoint.
Key CompetenciesLeadership and team developmentDecision making and problem solvingInfluencing and motivating teamsStrong organisational and time management skillsProfessionalism and self-awarenessExcellent interpersonal and communication skills
QC Operations Manager in Stevenage employer: Blackfield Associates
Join a leading pharmaceutical company in Slough as a Scientist in Antibody Formulation Development, where you will be part of a dynamic team that plays a crucial role in advancing innovative therapies. The company fosters a collaborative work culture, offering extensive opportunities for professional growth and development, alongside competitive benefits that support work-life balance. With a focus on cutting-edge research and a commitment to employee well-being, this is an excellent opportunity for those seeking meaningful and rewarding employment in the biotechnology field.
