Sr Manager Contamination Control Program Owner

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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At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal. Through 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 humanity. Learn 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.

Sr Manager Contamination Control Program Owner

You will partner with site leadership to develop maintain and improve the contamination prevention & control and microbiological hygiene programs for the Supply Chain Beerse Site. You will report to the Site Quality head and be part of the Quality Management team. You act as the primary microbiological subject matter expert supports microbiological contamination issues in the facility and gives pragmatic advice to production operators team leaders and management on topics concerning contamination risk prevention under cGMP requirements.

Education and Experience

• Masters Degree in Life Science or Engineering with a minimum of 10 years preferably in a healthcare products or comparable industry manufacturing or quality environment. (or Bachelors agree with increased experience required).
• Experience with Sterile Pharmaceutical manufacturing processes equipment and products.
• Experience with fundamental contamination control principles (gowning material flow aseptic behavior cleaning disinfection sterilization processes flows barrier systems and material transfer).
• Experience with risk management methodology preferably ICH Q9-R1
• Experience assembling and leading project teams and communicating outcomes issues and risks.

Responsibilities

You are the designated point of contact(s) who has oversight of the Contamination Control Program(s) and program team(s):

• You assemble and leads the Contamination Control Program team. Develops frequent meetings agendas action plans and documents team decisions.
• You partner with management to own and maintain the contamination control risk assessment(s) and strategies in accordance with cGMP Johnson & Johnson and regulatory requirements.
• You drive and realize improvements towards reduction of contamination risks and microbiological hygiene.
• You drive and engage the CCP team in the deployment of the contamination control program
• You perform and document independent assessments of contamination control measures across process personnel utilities facilities and products and drives proactive improvements in these control measures.
• You ensure the CCP team delivering frequently an evaluation report for the Site Management Review and develops related KPls
• You organize responses to potential adverse trends or events
• You serve on the Change Control Board to assess impact of changes to the Contamination Control Program
• You support site management in determining resource needs and succession planning
• You network with other Site-level Contamination Control Program teams to collaborate and share best practices.
• You perform tasks in a manner consistent with the safety policies quality systems and cGMP requirements.
• You proactively monitor regulatory requirements standards and best practices to proactively ensure compliance.

What Johnson & Johnson Offers

Working at Johnson & Johnson isnt just a job its an opportunity to build a fulfilling career with a purposeful global healthcare company guided by Our Credo!

As part of the Johnson & Johnson family youll benefit from:

• A meaningful and rewarding career contributing to healthcare solutions that impact patients lives every day
• Competitive total rewards including salary annual bonus and a strong pension and insurance package
• Flexible working arrangements supporting worklife balance
• Comprehensive health wellbeing and mental wellness programs including onsite and virtual fitness options
• Paid maternal and parental leave and familyfriendly policies
• Access to learning development and internal career opportunities across Johnson & Johnsons global organization
• Opportunities to engage with local community initiatives and social impact activities
• An inclusive collaborative workplace working with diverse international teams

Johnson & Johnson is an equal opportunity employer. We value diversity and inclusion and are committed to creating an environment where everyone is respected supported and able to contribute their best work.

We are committed to providing reasonable accommodations to individuals with disabilities throughout the application interview and hiring process. If you require an accommodation to participate in the recruitment process please let us know and we will work with you to support your needs.

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