Manager Quality Assurance

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Geel, Antwerp, Belgium 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 :

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,