Manager, Investigations

vor 6 Monaten

Bern, Schweiz Johnson & Johnson Vollzeit

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Manager, Investigations, to join MSIT (Manufacturing Science and Innovation Technology) team in Bern, Switzerland.**

Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of Johnson & Johnson work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 120,000 people.

Johnson & Johnson Innovative Medicine is a global pharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site, with its approx. 600 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral
- and bacterial vaccines and bacterial based therapeutic products.

**The Manager **will**:

- Lead and build a team to support the investigation and resolution of deviations and atypical events.
- Establish tools and metrics to monitor and streamline investigations and change implementation processes.
- Lead complex manufacturing investigations quickly driving to root cause to meet critical release windows.
- Provide technical expertise to help identify true root cause of investigations and assess product quality impact.
- Recommend corrective/preventative measures aimed at improving compliance and reducing repeat occurrences.
- Follow up to determine if corrective actions adequately addressed root cause of NC event.
- Track deviations, events and key process parameters and provides reports to management on trending, and status as requested.
- Recognize and act on potential compliance issues and opportunities for process changes/improvement.
- E2E oversight of the investigations.
- Partner with all Functional Cells and COE’s to implement process improvements.
- Assure regulatory compliance and technical feasibility of proposed changes.
- Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
- Maintain various databases of production information.
- Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC), the Annual Product Review (APR) and Contamination Control Strategy effectiveness assessment.
- Review and approve related documentation.

**Qualifications**:
**Qualifications**
- A minimum of a bachelors degree in a Scientific or related field is required.
- A minimum of eight (8) years of professional relevant business experience with at least four (4) years supporting investigations and/or change management in a highly regulated environment is required.
- Project management skills is required.
- Ability to read, analyze and interpret procedure manuals, common scientific and technical journals, general business periodicals and government regulations is required.
- Ability to respond to sensitive inquiries or complaints from top managers, regulatory agencies, or members of the business community is required.
- Experience with internal and external regulatory audits.
- Ability to utilize various standard programs for data entry and word processing is preferred.
- Ability to learn and operate various enterprise systems including eLIMS, Trackwise, Maximo, EMS, BMS, SAP is required.
- Excellent written and oral communication skill are required.
- This position is located in Bern.

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