QA Manager - API Small Molecule.

工作内容

Within Janssen Supply Chain, a member of Johnson & Johnson’s Family of Companies, we are recruiting a QA Manager (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 lifestyle of people worldwide. Janssen Supply Chain Quality (JSCQ) SM-API supports the Geel site in its mission as Launch & Grow 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 SM-API, you are responsible for the quality oversight of the Powder Handling Unit where APIs are sieved, milled and/or homogenized to obtain the appropriate characteristics for further processing. You take also ownership for the quality oversight and timely release of an assigned product portfolio of commercial APIs, including Controlled Substances, ensuring compliance with applicable regulations. You lead a team of QA professionals responsible for Quality processes such as Batch Record Review and PQR review and you act as Subject Matter Expert for the assigned Quality processes.

Job Description

• Act as Quality Point of Contact for the Powder Handling Unit, where API is sieved, milled and/or homogenized to obtain the appropriate characteristics for further processing.
• Establish and maintain strong working relationships with Business and Quality partners to ensure alignment of objectives and results. Strengthen the quality culture in the supporting departments by providing coaching and/or training on cGMP requirements.
• Lead a team of QA professionals responsible for Quality processes such as Batch Record Review and PQR review, by supporting, coaching and developing team members in reaching quality, business and personal objectives.
• Serve as Subject Matter Expert for the assigned Quality Processes such as Release, Batch Record Review, PQR and Controlled Substances.
• 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.
• 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