senior manager QC Operations ELM.
View: 128
Update day: 25-04-2024
Location: Schaffhausen Schaffhausen SH
Category: Other
Industry: Medical Equipment Manufacturing Hospitals Health Care Pharmaceutical Manufacturing
Job type: Full-time
Job content
Senior Manager QC Operations, Equipment Life Cycle Management (ELM)Janssen Pharmaceuticals, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Manager QC Operations, Equipment Life Cycle Management (ELM). This global role, supporting all JSCQ Labs, can be located in any J&J global location, preferably in proximity to a Janssen manufacturing or testing site.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us.
The Senior Manager QC Operations, ELM is responsible for
- Providing strategic direction and identify key opportunities to innovate and transform business processes.
- People and talent management of the ELM COE team with focus on diversity and inclusion.
- Performing project portfolio management and budget management for QC Operations
- Assuming Business process ownership of the overall Quality qualification process for JSCQ Labs, ensuring compliance and reliability, including inspection support where needed.
- Ensure lab equipment readiness for NPI.
- Lead equipment life cycle management & asset/investment optimization process for JSCQ.
- Lead strategy to simplify & standardize equipment software architecture, enabling digital integration to iLABs.
- Business Application support for standard J&J IT solutions , e.g. SDMS, Compliance Builder , Deskman.
- Provide site support to JSCQ Labs, drive optimization and standardization of ELM processes; lead multi-site initiatives to implement innovative solutions, improve compliance, reliability and efficiency.
- Lab single point of contact for ELIS global program.
Qualifications
Required
Experience and Skills:
- A minimum of a Bachelor’s Degree is required. Degree concentration in Life Science or technical discipline is preferred
- A minimum of eight (8) years of experience in the pharmaceutical industry
- Experience with GMP Equipment qualification processes is required.
- Experience in Quality Assurance/ Quality Control / Quality Systems / Compliance
- Proven people management experience
- Strong partnership skills, strong communication & change management skills
- Proven project management experience, including multi-site & multi region program deployment
- Knowledge of IT solutions and architecture , include the J&J SDLC framework
- Proven track record for implementing and leading change.
- Strong influencing skills, able to lead change and transform business processes with a strong implement decisions and to gain support for ideas and their vision
- Knowledge of cGMP regulations and FDA/EU guidance
- Good written and verbal communication skills
- This position may require up to 15% of domestic and international travel.
- Lean Six Sigma or other Process Excellence and/or PMP certification
Primary Location
Global
Other Locations
North America, Asia Pacific, Latin America, Europe/Middle East/Africa
Organization
Janssen Pharmaceuticals, Inc. (6062)
Job Function
Quality
Primary Location
Belgium-Antwerp-Beerse-
Other Locations
Latin America-Mexico-Puebla-Puebla, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Asia Pacific-China-Shaanxi-Xi’an, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-New Jersey-Raritan, North America-United States-Puerto Rico-Gurabo, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Greece-Attica-Athens, Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Ireland-Cork-Cork, Latin America-Brazil-São Paulo-São José dos Campos, Asia Pacific-South Korea-Chungcheongbuk-do-Jincheon-gun
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Quality
Requisition ID
2206013716W
Deadline: 09-06-2024
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