Manager Quality Assurance

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Job Description:

As QA Manager you lead a team of QA professionals responsible for timely release of commercial APIs ensuring compliance with applicable regulations. You act as QA Point of Contact ensuring quality oversight of the API production plant(s).You encourage your team and business partners to continuously strengthen the Quality and Compliance Culture of the site. You act as a leader who fosters an environment of innovative thinking.

Job Description:

Key Responsibilities

Leadership & Quality Culture

• Lead inspire and motivate a team of QA professionals responsible for the timely release of commercial APIs. Support coach and develop team members to achieve quality business and personal objectives.

• Establish and maintain strong working relationships with Business and Quality partners to ensure alignment of objectives and results.

• Strengthen the Quality and Compliance Culture across supporting departments by providing coaching and/or training on cGMP and regulatory requirements.

• Develop and foster an environment of innovative thinking by continuously challenging the status quo benchmarking industry practices and identifying opportunities for continuous improvement.

Quality Oversight & Compliance

• Act as the QA Point of Contact for the API production plant ensuring compliance with global regulations internal standards and Johnson & Johnson Quality Requirements.

• Ensure comprehensive quality oversight of operational activities including review and approval of GMP documentation such as procedures work instructions batch records protocols and reports.

• Review and support Annual Product Review (APR) and approve Continued Process Verification (CPV) reports for the assigned commercial API product portfolio.

• Serve as Subject Matter Expert (SME) for designated Quality Processes.

Product Release & Supply Reliability

• Ensure the timely release of commercial APIs manufactured at the Geel site working as One Team with QA and Supply Chain partners to maintain a reliable and uninterrupted supply chain.

• Act as spokesperson and primary QA representative during Health Authority inspections and customer audits.

Deviation CAPA & Change Control Management

• Ensure that Non-Conformances Deviations CAPAs Change Controls and Product Quality Complaints are timely and properly investigated. Provide quality compliance and technical expertise to ensure internal and external customer expectations are met.

• Ensure appropriate handling and escalation of Non-Conformances and Complaints with potential impact on patient safety product quality or supply continuity.

• Proactively escalate critical quality issues to senior management when needed.

Regulatory & Industry Knowledge

• Remain current with international regulations guidelines and industry best practices related to API manufacturing and Quality Assurance.

• Drive implementation of innovative initiatives that deliver sustainable improvements in organizational quality and compliance performance.

Standby Responsibility

• Take part in the standby / on-call rotation outside regular office hours (evenings and weekends) to support 24/7 manufacturing operations and ensure timely quality decision-making during continuous production.

Job Qualifications:

Required Qualifications

• Masters degree in a scientific field (e.g. Chemistry Bioengineering Pharmaceutical Sciences or related discipline).

• Minimum of 5 years of experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance.

• Proven experience as a Quality Release Responsible for commercial products (musthave).

• Strong knowledge of cGMP (domestic and international) ICH guidelines and relevant quality policies standards and procedures.

• Experience with Health Authority inspections audit readiness and regulatory interaction.

• Demonstrated ability to work independently while maintaining strong alignment with key stakeholders.

• Strong analytical and problemsolving skills with the ability to make sound riskbased decisions under time pressure.

• High level of accuracy proactivity and accountability in daytoday work.

Preferred Qualifications

• People leadership experience (formal or informal) is a strong asset.

• Strong leadership capabilities with the ability to shape influence and drive Quality strategy across local teams.

• Effective team player committed to working as One Team.

• Demonstrated ability to work across organizational boundaries through strong influencing negotiation and partnership skills.

• Excellent communication negotiation and presentation skills with the ability to engage all levels of the organization.

• Solid understanding of operational and business drivers and how quality decisions impact product patients and supply.

Fluent in Dutch and English languages and excellent communication skills.

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