Johnson & Johnson, Cork
Janssen Supply Group is recruiting a Pharmaceutical Regulatory Compliance Manager within the Johnson & Johnson Regulatory Compliance (JJRC) team! The position will be preferably located in Horsham, PA, Malvern, PA, Titusville, NJ, Raritan, NJ, Beerse, Belgium, Leiden, Netherlands or Cork, Ireland.
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 @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.
The Pharmaceutical Regulatory Compliance Manager will manage aspects of quality, regulatory and compliance issues. This is a travel heavy position and an opportunity to see multiple Janssen sites.
- Work closely with JJRC, quality assurance directors, and managers to assure compliance programs are implemented and maintained.
- Identify compliance issues that require further investigation and escalation. Consults with appropriate business partners and peers within PRC.
- Collaborates with business partners to mitigate compliance risks and support Internal manufacturing sites in preparing for routine GXP and pre-approval inspections by Health Authorities!
- assist during inspections and provide support with inspectional response and follow-up activities.
- Work with operating units to identify, prioritize and ensure implementation of new and revised regulatory requirements and expectations.
- Collaborate and build positive relationships within PRC and other key JSC stakeholders to acquire data inputs for IM compliance dashboards and metric templates to promote forward planning and best practices.
- Other job functions may be assigned as needed
- A minimum of a Bachelor’s degree or equivalent in the Sciences, Engineering, Business or Organizational Design is required.
Experience and Skills:
- Requiring a minimum of 8 years’ experience in pharma and biotech
- A minimum of 4 years in Quality, Regulatory, or Compliance functions within a Health Authority, pharmaceutical manufacturing
- A minimum of 4 years GXP environment
- Inspection support experience (FDA, EMA, and other Health authorities), project management experience, and experience with reporting tools such as SharePoint, Spotfire, Curve and Tableau are a plus.
- Skilled in pharma inspections, audit experience, CAPA experience
- This position may require up to 50% domestic & international travel
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
United States-New Jersey-Raritan-1000 US HIghway 202
Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Ireland-Cork
JANSSEN SUPPLY GROUP, LLC (6046)