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Head, Safety Compliance Management Job

Company Name:
Janssen Research & Development, LLC. (60
Horsham, PA, US
Head, Safety Compliance Management-9810140502
Description
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies is seeking a Head, Safety Compliance Management 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 Head, Safety Compliance Management is responsible for ensuring that GMO and its Pharmacovigilance (PV) vendors are in a state of inspection readiness by proactively monitoring key indicators of inspections readiness. He/she will 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 CMO.
The Head, Safety Compliance Management is also accountable to oversee the GMO CAPA process, 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. He/she 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 venues.
The Head, Safety Compliance Management will oversee and manage the GMO CAPA process to include oversight of all internal and relevant Vendor CAPAs. He/she will maintain a GMO CAPA process that complies with all J&J and Pharmaceutical standards and SOPs. This individual will drive leading practices in CAPA to sustain effectiveness and timeliness and quality of content. He/she will develop and deliver innovative and compliant approaches to CAPA training for all of GMO. The Head, Safety Compliance Management will drive overall GMO system inspection readiness. He/she will oversee training and educational programs to support this. 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. The Head, Safety Compliance Management will ensure a Quality and Compliance Oversight agreement is in place for each key GMO PV vendor. He/she will manage, lead and develop the CAPA and Inspection Readiness team. This individual will execute other key projects as required in consultation with the Head of CSA of an internal and external nature.
The Head, Safety Compliance Management will take overall accountability for implementation of strategies supporting sustainable global performance in GMO CAPA and GMO inspection readiness. He/she will coordinate activities with Head, GMO, Compliance Standards and Alliances and related organizations for defining and evaluating operational strategy of SCM. This individual will take overall accountability for defining and implementing organizational development strategies for SCM to ensure the leadership pipeline and organizational capabilities are maintained. The Head, Safety Compliance Management will take overall accountability within function for setting priorities (resource, operational) to achieve business plan targets for SCM.
Qualifications
A minimum of Bachelors Degree is required. An Advanced Business related Degree (MPH, MBA, JD) is preferred. A minimum of 9 years experience in a medical device and/or pharmaceutical regulated environment is required. Pharmacovigilance (PV) experience is preferred. A minimum of 5 years of supervisory 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
Primary Location:
North America-United States-Pennsylvania-Horsham
Organization:
Janssen Research & Development, LLC. (6084)
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.
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