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.
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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 , 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.
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
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.