QA Team Leader

QA Team Leader - Permanent- Hertfordshire - Shifts - up to £48,720 DOE Plus Shift Allowance

Join our dynamic global company located near a beautiful nature reserve in leafy Hertfordshire. We are dedicated to producing a range of life-saving medicines and are committed to creating a healthier, brighter future for all. With exciting growth on the horizon, we invite you to be part of our mission to make a real difference in people's lives.

As part of the QA Operations Team, you will manage QA activities related to production and review. You will ensure compliance with EHS, GXP regulatory standards, and internal quality protocols. This customer-facing role requires strong relationship-building skills across the organization.

Key Duties and Responsibilities

• Ensure compliance with Quality, GXP, and EHS standards.


• Close out deviation records and lead quality investigations.


• Communicate with Quality Operations Management to align quality targets with business priorities.


• Oversee the Quality Management System and relevant records.


• Handle customer complaints, deviations, and CAPAs promptly.


• Implement necessary Quality System improvements.


• Lead and manage a team of QA officers.


• Support manufacturing in managing deviations, CAPAs, and quality incidents.


• Provide compliance support and advice to internal departments.


• Perform trend analysis on deviations, CAPAs, and customer complaints.


• Manage product quality risks through a quality risk management approach.


• Deputize for the QA Operations Manager as needed.


• Lead internal audits and assist with regulatory audits.


• Identify and develop team skills and competencies through training and coaching.


• Review and improve team performance indicators.


• Support recruitment and onboarding of new employees.


• Ensure direct reports meet competence and behavior standards.


• Escalate compliance or delivery issues to management promptly.


• Perform additional tasks to maintain Quality Operations effectiveness.

Education, Skills, and Experience

Education

• Degree in a science discipline or equivalent.

Skills and Experience

• Significant experience in an operational quality role, preferably in a biopharmaceutical, clean room, or manufacturing environment.


• Knowledge of sterile aseptic filling and packing processes.


• Experience leading a team and managing others.


• Proficiency with documentation and quality management systems.


• Risk management and statistical analysis experience.


• Commitment to continuous improvement.