Manager QA - Lab & Release.

仕事内容

Within Janssen Supply Chain, a member of Johnson & Johnson’s Family of Companies, we are recruiting a QA Manager - Lab & Release (M/F/X) as member of our Quality team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) based in Geel, Belgium.

Janssen Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of SM-APIs used in treatments that improve the health and lifestyles of people worldwide. Janssen Supply Chain Quality (JSCQ) SM-API supports the Geel site in its mission as Launch & Growth site and is responsible for the quality oversight and final release of SM-APIs guaranteeing reliable supplies in compliance with applicable regulations.

As QA Manager Lab & Release, you will lead a team of QA professionals responsible for the quality oversight of the laboratory and for supporting processes such as Batch Record Review and PQR review. You will also take ownership for the quality oversight and timely release of an assigned product portfolio of commercial APIs, including Controlled Substances, ensuring compliance with applicable regulations.

Job Description

• Lead a team of QA professionals responsible for the quality oversight of the laboratory by supporting, coaching and developing team members in reaching quality, business and personal objectives.
• Establish and maintain strong working relationships with Business and Quality partners to ensure alignment of objectives and results. Act as Quality Point of Contact for the laboratory and for the release of an assigned product portfolio as well as for supporting processes such as Batch Record Review and PQR review.
• Strengthen the quality culture in the operational departments by providing coaching and/or training on cGMP requirements
• Keep Quality oversight and perform timely release of commercial APIs, including Controlled Substances, manufactured at Janssen’s Supply Chain site in Geel. Work as One team with QA and Supply Chain partners to ensure timely release in support of a reliable supply chain.
• Support the quality oversight process of the operational activities by ensuring QA review and approval of GMP documentation and participate in the different quality review meetings.
• Ensure that deviations, CAPAs, Change Controls and Product Quality Complaints are timely and properly investigated by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.
• Ensure that deviations and complaints with potential impact on patient safety and/or product supply are properly escalated.
• With focus on Quality activities, develop and foster an environment of innovative thinking through e.g. benchmarking, training, participating in industry fora. Continuously challenge the status quo by identifying opportunities for continuous improvement. Drive the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.
• Serve as Subject Matter Expert for the assigned Quality Processes e.g. Batch Record Review, PQR, and Controlled Substances.
• Remain current in knowledge and skills towards regulatory and industry trends.
• Act as spokesperson during Health Authority inspections and customer audits.
  
  

Qualifications

• Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer, …). Industrial Pharmacist - EU certified Qualified Person is an asset.
• At least 5 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance. Experience as release responsible is an asset.
• Experience with management of Controlled Substances is an asset.
• People leadership experience is an asset.
• Demonstrated ability to work independently while staying connected with key stakeholders.
• Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication and presentation skills across all levels of the organization are important.
• Strong analytical thinking skills and able to work in a flexible way under time pressure. Ability to make risk based decision under time pressure. Understands the business implications regarding quality positions and decisions.
• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
• Experience with Quality Systems.
• Experience with regulatory inspections and preparedness.
  
  

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location

Belgium-Antwerp-Geel-

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

Engineering

Requisition ID

2206028374W