Assoc. Dir. PhV Audit Programme Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

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 independently coaches others to support talent development and training to meet current and future business needs.
• Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.

People Management

• This is an individual contributor role.
• Deputizes for Director PV Audit Strategy Lead when requested.

Project Management

• Takes an active role in and leads projects and teams in key project initiatives across the organization or company. Influences stakeholders and determines priorities checkpoints and timelines for all aspects of work and projects to achieve adequate progress. Effectively drives projects to completion.

Program Expertise

• Maintains expert level of Pharmacovigilance and PV related IT knowledge with the ability to provide critical information advice and guidance on complex quality and compliance issues.
• Proactively identifies the need for and leads information sharing initiatives. Interprets and applies regulations and policies to unique and complex issues to influence decisions and actions. Independently provides strategic advice to internal or external stakeholders to drive policy and decision making.
• May serve as a primary contact for internal and external stakeholders and represent RDQ in an expert capacity.
• Communicates internally to ensure a departmental unified position regarding advice and consultation is provided.
• Collaborate with relevant business partners global project teams and RDQ colleagues to ensure robust audit plans.
• Interprets and applies regulations and policies to unique and complex issues to influence decisions and actions
• Responsible to partner closely with RDQ colleagues across sector to ensure One Quality Voice for PV risk assessments PV audit programme; aggregate analysis and management reports (Quality & Business Partners).
• Responsible for trending of data from the pharmacovigilance audit program including translation of audit trends and outcomes into actionable risk insights.
• Supports the development of digital and data solutions to transform the E2E audit process including automated risk-prioritization tools and their maintenance.

Qualifications:

• A minimum of a bachelors degree is required. An advanced degree is preferred.
• A minimum of 8 years of experience in the pharmaceutical/biotech industry is required.
• Fluent knowledge of English language.
• Pharmacovigilance Quality and Compliance experience is required.
• Experience in Pharmacovigilance audit required.
• Experience working with digital tools and systems is required.
• Audit strategy experience is preferred.
• Strong collaboration with business partners and strategic thinking required.
• Experience with driving culture and change management across a large organization is preferred.
• Experience with project leadership preferred.

Travel Requirements:

• Up to 25% travel as per business needs.

The expected base pay range for this position is $122000 to $212750

For additional general information on Company benefits please go to: Skills:

Preferred Skills:

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: