ASSOCIATE DIRECTOR, PHARMACOVIGILANCE AUDIT TEAM 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.
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Auditing Provides support and input to shape and transform R&D Quality PV tactical and operational audit plans to ensure efficiency and sustainability of the audit program, while ensuring it continues to meet global regulatory expectations.
Act as the QA contact with regional partners to develop and align QA compliance positions in audit execution Advance and enable risk based auditing as a routine way of working.
Accountable for translating risk profiles into regional audit strategies to build PV risk-based audit plans and scopes, driving and shaping continuous improvement and process optimization.
Independently leads all aspects of audit execution to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.
This includes for cause, complex and business critical audits.
Guides auditors in the scope definition, planning, conduct and reporting of audits, providing regulatory and process expertise.
Identifies areas of opportunity for consistency of CAPAs for similar issues across the region to drive efficiencies in business operations and compliance levels.
Identifies and resolves regional audit plan challenges and supports the strategic direction for the global audit plan.
Ensures appropriate allocation of auditors to audits within the PV domain.
Backup for auditors during periods of high workload or unforeseen circumstances to ensure business continuity.
Conducts peer review of audit reports.
Inspection Support Ensures appropriate resources are allocated to support Health Authority inspections, as needed.
May support regulatory inspection activities commensurate with expertise.
Assists with PV QA activities related to HA Inspections, including inspection readiness and coordinating with other functions as needed Training & Development Identifies training needs.
Develops training and development strategies for team to be able to support GxP compliance activities and ensure required skills are available to deliver the audit schedule.
Provides career guidance and ensures development plans are in place for direct reports.
Ensures that each team member is knowledgeable about compliance in the assigned domain.
Proactively and independently coaches team and others to support talent development and training to meet current and future business needs.
Supports the review and approval of training curriculum as applicable to area(s) of expertise.
Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.
Actively supervises auditor skills and abilities to maintain global alignment.
People Management Directly responsible and accountable for supervision and development of direct reports (a team of PV auditors).
Deputizes for PV Domain Leadership when requested.
Drives and implements talent strategies in a standard, fair and clear approach.
Promotes a fair framework of recognition and reward, a mature sense of discipline, open communication and mutual respect.
Creates an environment which encourages the company’s Credo commitment to equal employment opportunity and the value of a diverse workforce.
Project Management Takes an active role in, and leads, projects and teams in key project initiatives across the organization or company.
Determines priorities, checkpoints, and timelines to achieve adequate progress.
Effectively drives projects to completion.
Domain Expertise Maintains expert level of Pharmacovigilance and Quality Managements System knowledge with the ability to provide critical information, advice and guidance on complex issues.
Apply and implement innovative QA audit methodologies focusing on reaching deeper compliance insights.
Mentor auditors to leverage data analytics tools to analyze relevant data sources.
Evaluate and analyze the data to identify relevant trends and insights as an input for the development of the audit program.
Support auditors to provide expertise and knowledge on quality and compliance processes/procedures.
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 partners to drive policy and decision making.
May serve as a primary contact for internal and external partners and represent R&D Quality in an expert capacity.
Communicates internally to ensure a departmental unified position regarding advice and consultation is provided.
Collaborate with relevant business partners to ensure robust audit plans.
Qualifications A minimum of a bachelor’s degree is required.
An advanced degree is preferred.
A minimum of 8 years of experience in the pharmaceutical/biotech industry is required.
Pharmacovigilance Quality and Compliance experience is required.
Knowledge of Pharmacovigilance and/or QMS audit 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.
Up to 25% travel as per business needs We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.
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.