QA Manager - mRNA/SSF/NPI
Purpose of Role
The purpose of the role is to support and lead a team of QA Specialists for both existing manufacture of commercial, IMP products and new product transfers within the area.
The role involves QA leadership in relation to manufacture, testing and release of products according to Pfizer Quality Standards (PQS) and Grange Castle Standard Operating Procedures (GC SOP). The QA Manager represents Quality and Compliance requirements throughout a product life-cycle from design, Process Validation through to commercialization as applicable QA Manager works in partnership with engineers, operations, technical services and contract personnel. The role will have oversight in relation to batch disposition, quality and compliance for all products manufactured within the suite.
- Represent QA at product, technical and robustness team meetings and lead/drive all associated support activities. Act as delegate for OpU QA Lead as required.
- Participate in cross-functional teams as required where strategic leadership is required.
- Appropriately delegate workload to drive project timelines in a compliant manner, based on experience, knowledge and history of previous projects. Identify strengths and talents within the team drive this delegation.
- Contribute to promoting a ‘Right First Time’ and ‘Continuous Improvement culture’ with the project quality and wider teams, by using analytical tools, introduction/updating of site systems and solutions.
- Ensure releasing QPs have all the data and information required to make an informed batch release decision, and that all required batch paperwork has been reviewed and closed.
- Liaise between the team and all customers both internal and external.
- Support Operations teams with investigations and resolution of discrepancies. To provide consultative support on quality related issues to Manufacturing Operations.
- Ensure that manufacturing operations and documentation of manufacturing activities are performed in a manner which is compliant with Pfizer Quality Standards and Grange Castle Standard Operating Procedures.
- Represent and support the team to ensure team, Quality OpU and site metrics are met.
- Ensure issues are escalated as appropriate to OpU QA Lead and SQOL, and that feedback is sought in a timely manner.
- Ensure the area is inspection ready and support regulatory inspections, regulatory filings and queries.
- Ensure weekly, monthly, quarterly and annual reports are generated in a timely manner as required.
- Use visual management to track and trend activities required.
- Regularly report out to management on achievements and challenges.
- Ensure that GC Quality system SOP (Deviations, Change Control) are applied as appropriate in the project lifecycle.
- Lead continuous inspection readiness for QA.
- Drive a culture of continuous improvement within QA.
- Challenge and develop talent within the QA Specialist team.
- Enhance agility and flexibility within the team and across teams.
- Perform and assist with additional duties as may be directed by the OpU QA Lead.
- Designee for OpU QA Lead as required.
- Hold a B.Sc. degree in biological/chemical sciences or other related technical degree or equivalent experience in regulated industry.
- Preferably 5-10 years quality experience in a biotech, pharmaceutical, or bio- pharmaceutical manufacturing environment.
- Ideal candidate should have extensive knowledge in technical transfer of new products to site.
- Previous relevant Quality experience as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company desirable
- Knowledge of Single use systems in manufacturing processes an advantage.
- Experience of involvement in technical issue resolution, in a multidisciplinary environment.
- Excellent communication and interpersonal skills.
- Demonstrated ability to successfully collaborate, influence and lead in a matrix organization.
- Proven record in demonstrating agility.
- Ensure the Pfizer Values form the basis of how the team operates.
- Implement and ensure team adheres to all HR policies as appropriate.
- Manage Core time management for all FTEs & report out performance.
- Complete monthly One: Ones with all direct reports.
- Ensure contingent staff are managed appropriately - performance, training 1-1.
- Develop SMART Objectives for the full team.
- Develop development plans focusing on the 70:20:10 guidelines.
- Develop CI capability and utilize CI tools to drive improvements in the area.
- Proactive engagement with key stakeholders.
- Recognition is actively practices by you and your team.
- Best practices developed and shared with other teams/sites.
- Best practices actively sought and copied.
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