Johnson & Johnson Careers
Sr Specialist Change Control Management
Requisition ID: 1905745802W
For the Department Janssen Supply Chain - PES API (Active Pharmaceutical Ingredients) we are looking for a Professional working on the execution of PES initiated change control processes for API, intermediate, Raw Material and Packing
- Execution of PES change control processes in conformance to current standards and procedures, using applicable system application tools.
- Ensure integrity, consistency and compliance of processes for JSC globally.
- Assure successful implementation of changes and actions by following up and synchronizing activities for all participants, communicating status for implementations to key stakeholders
- Provide product and Supply Chain knowledge to ensure proper implementation and compliance
- Partner with other areas of Supply Chain and actively develop and manage relationships with process users, business owners, J&J affiliates and external organizations.
- Bsc in Physical or Life Science
- Preferably Process Excellence certification
- 8 - 10 years of related experience, including significant experience in pharmaceutical or other related or highly regulated industry
- Min. 3 years’ experience in leading virtual teams
- Strong Program & Project Management Skills
- Demonstrated experience to lead complex change implementations confidently.
- Demonstrated understanding of manufacturing processes and associated GMP compliance requirements. Able to apply this knowledge to lead and develop change control process strategies for global needs
- Demonstrated understanding of global Regulatory Affairs legislation and Regulatory Compliance requirements. Able to apply this knowledge to evaluate changes and assess potential risk introduced to the business as result of changes
- Ability to engage and align with other diverse and dispersed organizations and functions. Ability to negotiate, influence and lead without direct line authority. Ability to engage others and lead an organization through continuous improvement and change.
Europe/Middle East/Africa-Switzerland-Zug-Zug, North America-United States-Pennsylvania-Horsham
Janssen Pharmaceutica N.V. (7555)