Director, CAPA and Compliance Strategy-3157140825
Description
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies is seeking a Director, CAPA and Compliance Strategy to be located in Horsham, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Research & Development, L.L.C. thrives on a diverse company culture, celebrates the uniqueness of our employees and is committed to inclusion. We are proud to be an equal opportunity employer.
The Director, CAPA and Compliance Strategy position is a rare opportunity to help shape and drive the institutional readiness for one of the most successful drug pipelines in the current Pharmaceutical industry. The Director, CAPA and Compliance Strategy is responsible for ensuring that J&J’s Global Medical Organization(GMO) and its Pharmacovigilance (PV) vendors are in a state of inspection readiness by proactively monitoring key indicators of inspections readiness. This job will leverage your knowledge of risk and ensure a GMO process is in place to manage audits and inspections. This individual will partner with key partners, internal and external to GMO, to proactively mitigate compliance risk for all areas of GMO (including key PV vendor services), and defining key indicators of inspection readiness for all areas of GMO as well as for the Office of the J&J Chief Medical Officer. This position offers opportunities to partner cross functionally to drive clear strategy for compliance, provides high visibility and is established as a key position in high performing team.
The Director, CAPA and Compliance Strategy is also accountable to oversee the GMO Corrective and Preventive Action (CAPA) governance and oversight, ensuring it is compliant in areas of effectiveness, timeliness, quality and thoroughness of content and managing the implementation and use of a validated CAPA database within GMO functions. The Director, CAPA and Compliance Strategy will be responsible for monitoring of CAPA compliance by ensuring a robust CAPA governance process is in place and that CAPA metrics are defined and published to senior leaders and other stakeholders to support Management Review, the Janssen Medical Safety Council, CAPA Review Board and other relevant oversight and governance venues.
He/she will oversee training and educational programs to support the above areas. This individual will work with R&D Quality and Compliance and GMO functional groups to drive or support development of clear PV Compliance and Inspection Readiness standards. He/she will manage, lead and develop the CAPA and Inspection Readiness teams.
This individual will execute other key projects as required in consultation with the Head of Compliance Strategy and Analytics of an internal and external nature.
This individual will take overall accountability for defining and implementing organizational development strategies for the CAPA and Inspection Readiness teams to ensure the leadership pipeline and organizational capabilities are maintained and will take overall accountability within function for setting priorities (resource, operational) to achieve business plan targets.
Qualifications
A minimum of Bachelors Degree is required. An Advanced Business related Degree (MPH, MBA, JD) is preferred. A minimum of 10 years’ experience in a medical device and/or pharmaceutical regulated environment is required. Pharmacovigilance (PV) experience is preferred. A minimum of 5 years of direct people management experience is required. Demonstrated experience in supporting global health inspections and establishing or sustaining an integrated quality system is required. Demonstrated experience in the areas of Corrective and Preventive Action Process development is required. The ability to ensure inspection readiness from a regulatory and compliance perspective is required. Demonstrated track record of achievement of business outcomes and a results oriented history is required. Demonstrated track-record in organizational development, leadership, people management and managing change across a diverse global organization are preferred.
This position will be located in Horsham, PA, and requires up to 15% travel, including potential international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
J2W:ASQ_Phil
J2W:ASQ_Princeton
J2W:ISPE
J2W:PennSt_PSA
J2W:PHDs_org
Primary Location:North America-United States-Pennsylvania-Horsham
Organization: Janssen Research & Development, LLC. (6084)
Travel:Yes, 10 % of the Time
Job Function: Pharmacovigilance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement