Sr Manager
Il y a 4 mois
This **Sr Manager - QA Clinical Supply Chain **reports to the IMP Qualified Person, and acts as a back-up QP, actively supporting the QP certification activities for investigational products, with a primary focus on products in early development (Small Molecules, Large Molecules and Advanced Therapies) and acts as a key spokesperson during inspections.
This role will support the Qualified Person to ensure compliance to applicable procedures and guideline for all activities that are part of the Clinical Supply Chain world-wide (CSC) and will support continuous inspection readiness. This can only be achieved by teaming up with partners in the CSC, with other quality functions and with multiple other functions that are collaborating in the development of a product, next to members of the own department.
This role will also help to prepare our QA CSC team for the future, by analyzing key performance metrics and defining, implementing and tracking key strategic objectives, continuous improvements and standardization efforts. An important example is being the Subject Matter Expert on and ensuring the implementation of phase appropriate GMP’s.
The key accountabilities also include coaching a team of 4 direct reports.
This role also has the ability to also represent J&J in different global fora such as ECA, EFPIA, EU CTR working group,
**Qualifications**:
- QP Certification is required
- A minimum of 7 years experience in the pharmaceutical industry is required.
- Strong team player and ability to collaborate and lead quality initiatives across multiple functions/organizations.
- Strong project management skills.
- Ability and experience to proactively identify and mitigate risk.
- Solution oriented, analytical and decisive.
- Experience in operations and/or development activities.
- Strong communication skills and demonstrated leadership skills.
This position is based in Beerse, Belgium
- Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability._
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