Sr QA Release Responsible Npi
Il y a 6 mois
**Sr QA Release Responsible New Product Introduction (M/F/X)**
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 Johnson & Johnson, Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a **Sr QA Release Responsible New Product Introduction (M/F/X) **as member of our Quality team, based in Beerse/Geel, Belgium, overseeing Development and Clinical Supply Chain activities for Small Molecule Active Pharmaceutical Ingredients (SM-API) used in clinical trials, ensuring compliance with applicable regulations.
As a Sr QA Release Responsible New Product Introduction, you are responsible for the quality oversight of a defined API product portfolio during the entire development phase (from early development over late development until introduction into the commercial Supply Chain organization). You drive the design and implementation of a Phase Appropriate GMP Quality System for chemical APIs as well as new modalities such as oligonucleotides and peptides.
**- 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 Chemical Pilot Plants and for the release of an assigned API product portfolio.
- Assure Quality milestones and stage gate deliverables are achieved within the project timelines, including timely release.
- Support the quality oversight process of the operational activities by ensuring QA review and approval of GMP documentation.
- 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 related to APIs
- Bring creative solutions to define a compliant quality strategy with flexibility for business needs, including for new modalities such as oligonucleotides and peptides.
- Act as spokesperson during Health Authority inspections and customer audits.
**Qualifications**:
- Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer, microbiology ).
- 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 within sterile/aseptic/low bioburden manufacturing is an asset.
- Ability to quickly assimilate new modalities and technologies.
- Demonstrated ability to work independently while staying connected with key stakeholders.
- Strong analytical thinking skills, solution oriented thinking 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.
- 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 Quality Systems.
- Experience with regulatory inspections and preparedness.
- Project management skills
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.
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