QA Manager
Il y a 6 mois
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”
Within Supply Chain Quality Small Molecules, a member of J&J Innovative Medicines, we are recruiting a **QA Manager Small Molecule API (M/F/X) **.** **You will be a member of our QA commercial API team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) based in Geel, Belgium. You will be part of an enthusiastic team ensuring quality oversight of the production plants and timely release of commercial API’s, ensuring compliance with applicable regulations.
The Geel site 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. Supply Chain Quality Small Molecules 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, 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 plants. **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.**
- Lead, inspire and motivate a team of QA professionals responsible for timely release of commercial APIs, 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 and Compliance Culture at the site by providing coaching and/or training on cGMP requirements.
- Act as QA Point of Contact for an API production plant ensuring compliance with global regulations and J&J quality requirements.
- Ensure quality oversight of the operational activities by reviewing and approval of GMP documentation and participating in quality review meetings.
- Ensure timely release of commercial APIs manufactured at the Geel site. Work as One team with QA and Supply Chain partners to ensure timely release in support of a reliable supply chain.
- 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 pro-actively and properly escalated to senior management.
- Develop and foster an environment of innovative thinking by continuously challenging the status quo and identifying opportunities for continuous improvement.
- Remain current in knowledge of international regulations, guidelines and industry practices.
- Act as spokesperson during Health Authority inspections and customer audits.
**Qualifications**:
**Job Qualifications**:
- Master Scientific degree (chemistry, bioengineer, pharmaceutical sciences, ).
- At least 5 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance. Experience as release responsible is a must.
- People leadership experience is an asset.
- Demonstrated ability to work independently while staying connected with key stakeholders.
- Strong leadership skills in order to shape and drive the Quality strategy in local teams.
- Strong team player, acting as One Team.
- 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.
- In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures. Experience with regulatory inspections and preparedness.
- Strong analytical thinking skills and able to work in a flexible way under time pressure. Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.
- You work accurately and proactively.
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