Regulatory Compliance Manager
vor 1 Monat
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 Latina, Italy, Zug, Switzerland, Horsham, PA, Malvern, PA, Titusville, NJ, Raritan, NJ, Beerse, Belgium, Leiden, Netherlands or Cork, Ireland.
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.
**Key Responsibilities**:
- 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
**Qualifications**:
**Education**:
- A minimum of a Bachelor’s degree or equivalent in the Sciences, Engineering, Business or Organizational Design is required.
**Experience and Skills**:
**Required**:
- 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
**Preferred**:
- 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
**Other**:
- This position may require up to 50% domestic & international travel
- The anticipated base pay range for the position with the United States is $93,000 to $139,000.
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.
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