Team Lead F2P2 DAOI

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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The Senior Supervisor will lead the optical inspection team within F2P2 supporting clinical programs and expanding capabilities toward process automation and increased capacity. He/She will also lead the device assembly team and be responsible for the on-time assembly of batches for clinical supplies and the onboarding of new capabilities. The Senior Supervisor will work closely with local DP Manufacturing QA Compliance IMSC OI and Engineering to ensure equipment and facility readiness for device capacity ramp-up and the operationalization of platform devices.

• Responsible for the manufacturing of drug product and/or combination products for clinical and commercial supplies manufactured in DPDS F2P2 according to current manufacturing schedule.

• Responsible for adherence to compliance and GMP standards in production.

• Leading and coordination (planning resources cost) of the production team in DPDS F2P2

• Define team lead objectives translate them into activities and take responsibility for the team performance

• Personnel management of F2P2 production team

• Responsible for production plan in alignment with Global Planning

• Responsible for supply of clinical and commercial material according to EHS and regulatory requirements

• Inspection representative as subject matter expert for CM&T F2P2 production with responsibility for internal and external audit readiness

• Joint responsibility to manage and support qualification review and validation tasks

• Responsible for the quality of supplies and batch records of the team that meets the agreed quality and compliance standards

• Documentation management (batch records protocols reports SOPs event/deviation) as owner reviewer and approver.

• Support implementation of new NPIs in CM&T F2P2

• Collaboration with other departments across DPDS and Janssen Pharmaceuticals to ensure reliable clinical and commercial supply

• Support LEAN implementation and continuous improvement projects

• Compliance with the GMP EHS and SOX requirements and guidelines which are connected to the respective functions.

Minimal requirements:

• Masters degree with engineering or scientific orientation.

• At least 5 years of professional experience in related activities within the healthcare industry. Hands-on experience in parenteral visual inspection and/or device assembly is preferred.

• Experience in the management and development of employees as well as in change management.

• Excellent knowledge of Deviation system change control system and continuous improvement.

• Excellent analytical skills communication strength empathy assertiveness and high customer and business orientation.

• Very good level of English both spoken and written. German is a plus.

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