Assoc. Dir. PhV Audit Programme Lead

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 jnj.com

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.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• United Kingdom, Belgium, Spain, France and Italy - Requisition Number: R-056054
• Switzerland - Requisition Number: R-059017
• United States - Requisition Number: R-059013

J&J Innovative Medicine is recruiting for a Associate Director, Pharmacovigilance Audit Programme Lead reporting to the Director, Pharmacovigilance Audit Strategy and to be based in one of the locations where the position has been posted. The candidate will join the R&D Quality J&J Innovative Medicine organization focusing on RDQ QA PV audit strategies for Local Operating Companies (LOCs) and External Supplier Providers (ESPs)

Main responsibilities will include, but are not limited to:
Audit Strategy and Auditing

• Providing support and input to shape, transform, and execute RDQ QA PV audit strategies for all audit types including Local Operating Companies (LOCs) and External Supplier Providers (ESPs) in order to enhance the effectiveness and sustainability of the audit program, while ensuring the audit program continues to meet global regulatory expectations.
• Manage and mature audit strategy and digital tools in line with evolving regulatory environment and company risk profile.
• Manages and maintains audit risk prioritisation tools, reviews risk profiles provides expert input to risk management strategies and translate them into audit plans and audit scopes, driving and shaping continuous improvement and process optimization.
• Independently leads the planning, conduct, reporting of RDQ QA routine and non-routine audits to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Manages complex or business critical audits/issues in a supporting or leading role. Leverage data analytics tools to analyze relevant data sources. Evaluate and analyze the data to identify any relevant trends and insights as an input for the development of the appropriate audit program.
• Support continuous improvement in RDQ QA PV audit methodologies.
• Advance and enable risk-based auditing as a routine way of working.
• Work within RDQ and with business partners to develop and align QA compliance positions.
• Supports auditors in the scope definition, planning, conduct and reporting of Pharmacovigilance audits providing regulatory and process expertise within the designated domain.
• Provides expert support to auditors and business partners when developing and/or approving CAPAs. Drives resolution of complex CAPAs. Proactively seeks solutions and contributes to strategic direction to foster robust CAPA processes including business partner guidance, appropriateness and timeliness of CAPA activities and management of timelines.

Inspection Support

• Provide support for regulatory inspection activities commensurate with expertise.

Training & Development

• Supports training and development strategies for team to be able to support PV compliance activities, collaborating within RDQ and with the business as required to ensure required skills are available to execute cross sector PV audit schedule.
• Proactively and indepe