Senior QA Manager SM-API

Job content

Within Janssen Supply Chain, a member of Johnson & Johnson’s Family of Companies, we are recruiting a Senior 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 Senior QA Manager SM-API, you lead a team of QA professionals responsible for the Quality Systems at the Geel site. You take ownership for the timely release of materials used in the API synthesis process as well as the release of final API manufactured at Contract Manufacturers and used within the Janssen Drug Product network. You have quality oversight of the Quality Control laboratories, responsible for testing of final API as well as API intermediates, and of the Logistics area, including weighing, storage and distribution, ensuring compliance with applicable regulations.

Job Description

• Lead a team of QA professionals 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. Strengthen the quality culture in the supporting departments by providing coaching and/or training on cGMP requirements.
• Act as QA Point of Contact for the Quality Control laboratories ensuring compliance with global regulations and J&J quality requirements. Leads and coaches a team of QA SMEs specialized in different analytical techniques.
• Act as QA Point of Contact for the Logistics area where materials are weighed, stored and distributed in line with Good Distribution Practices. Leads and coaches a team of QA SMEs ensuring quality oversight of the operational activities.
• Coordinate and lead Quality review meetings governing Quality and Compliance metric and operational business performance of the Quality Unit. Identifies trends and defines actions ensuring continuous improvement of the Quality and Compliance performance of the site in an effort to continuously strengthen the Quality Culture of the site.
• Ensure lab related GMP documents such as method transfer protocols and reports, investigations, etc are timely reviewed and approved in line with regulatory requirements
• Review and approve procedures and work instructions
• Ensure that quality records such as investigations, CAPAs, Change Controls, Product Quality Complaints related to the QC and Logistics areas are timely and properly handled 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.
• Apply Quality Risk Management tools in support of risk based decision making balancing business implications with Quality and Compliance requirements.
• 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 10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality.
• People management skills, preferably experienced team leader for Quality or Supply Chain team.
• 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.
• Ability to provide strategic leadership to meet business objectives and a highly dynamic business environment
• Experience with Quality Systems.
• In-depth knowledge in GMP and GDP (domestic & international), ICH guidelines, policies, standards and procedures.
• Experience with regulatory inspections and preparedness.
• Analytical expertise required. Knowledge of laboratory equipment validation and computerized systems is an asset.
• Logistic expertise required. Knowledge of Good Distribution Practices.
• 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.
• Ability to quickly assimilate new technologies/analytical methods, perform risk assessment and develop action plans
  

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

Quality

Requisition ID

2206061347W