Pharmacovigilance Quality Assurance Manager

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.

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):

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Pharmacovigilance Quality Assurance Manager.

Key responsibilities:

Auditing

• Independently leads the planning, conduct, reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes in GxP/non-regulated to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. Manages complex or business critical audits/issues in a supporting or leading role.
• Supports other auditors in planning, conduct and reporting of audits.
• Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
• Supports the CAPA process following the audit as needed.
• Encourages and supports others to properly manage and document the risk-based approach in the audit planning and conduct

Inspection Support

• May participate in regulatory inspections in a leadership role (e.g. host, backroom lead)

Training & Development

• Identifies training needs. Supports Development and provides training. Independently advises and coaches other auditors.
• Involved with the review and approval of curriculum as applicable
• Completes training requirements in a timely manner to ensure inspection readiness at all times.

People Management

• Able to supervise junior auditors/contractors
• Deputizes for Team Lead, as required.

Project Management

• Leads initiatives and actively participates in key projects across the organization or company. Interacts with key stakeholders and can influence and effectively drive projects to completion.

Expertise

• Actively shares business area and regulatory knowledge/expertise. May act as a primary contact for internal and/or external stakeholders.
• Conducts Peer review of audit reports, as required.
• Independently provides consultation and advice to Business Partners on quality and compliance processes/procedures.
• Interprets and applies regulations/policies to unique and/or complex issues, when required.

Qualifications

Education:

• Minimum bachelor’s or equivalent University degree required; Focused degree in a life, natural, or computer science is preferred

Experience and Skills:

Required:

• A minimum of 6 years of relevant work experience in a GxP Regulated industry including 3 years in pharmacovigilance auditing
• Strong project management experience
• Strong verbal and written skills, including presentation skills.
• Strong teamwork and analytical skills

Preferred:

• Experience in leading complex pharmacovigilance audit types e.g., system audits

Other:

• Must be fluent in English.
• This position requires 25% domestic and international travel.

#LI-Hybrid

Required Skills:

Preferred Skills: