The QA Manager is responsible for all aspects of assigned QA Team; provides leadership and support to direct reports. Provides QA oversight to ensure that all drug product manufacturing activities are compliant with company policies, procedures and in accordance with cGMPs.
- Support the Head of Quality with the quality function oversight
- Maintain the Pharmaceutical Quality System to include: Personnel, Premises & Equipment, Production, QC, Outsourced activities, Complaints, Investigations, Self-Inspections
- Ensure all work carried out is compliant with company standards, cGxP, SOPs, regulations and guidelines, safety, and environmental guidelines
- Continuously promote a positive safety culture. Implement Safety requirements as per site documentation including SOPs, Safety Statement
- Collaborate cross-functionally with all departments and represent Quality on the Sterile Supply Value Stream
- Investigations management and approval
- Deviations & Complaints
- Out-of-Specifications, Out-of-Calibrations, Out-of-Trends
- Elevate Quality issues to the Head of Quality and Senior Management where required, working collaboratively with the Sterile Fill Finish Manager to provide direction and support in critical interventions
- Manage Self Inspection Program
- Manage and host site Inspections (Customer audits / Regulatory inspections etc.)
- Batch documentation review ensuring compliance to standards and SOP’s
- Batch package preparation for QP release
- Manage Vendor Qualification
- API and excipient disposition
- Primary & Secondary component disposition
- Provide oversight of any Contract Manufacturing activities related to Sterile Fill Finish
- Manage metrics, performance, and review with the Site Leadership Team
- Quality management representative on the Area Management Team, ensuring the effective running of the business
- Involved in the recruitment, leadership, and career development of Quality Assurance members
- Creation of Quality department goals aligned with site strategy and objectives
- Performance evaluations for direct reports
- Quality department budgeting.
- Primary degree in a scientific discipline
- Minimum 8 years’ experience in the biopharmaceutical industry, 5 of which should be within a Quality function
- Minimum 4 years of leadership experience, including team coaching and development
- Experience of Quality Assurance of aseptic medicinal products and biopharmaceuticals.
- Experience in using lean methodologies and / or operating within Value Streams
- The candidate is eligible to act as a Qualified Person as described in EU Directives, would be an advantage
- Extensive knowledge of electronic QMS systems – EDMS, ERP, TrackWise etc.
- Experience preparing and hosting Customer & Regulatory Inspections
- Lead auditor experience
For a confidential discussion and more information on the role, please contact Josh Barnes.