Pharmacovigilance Quality Assurance Manager

About the role

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):

Brazil R-110867, Canada R-110868, United States of America R-096642

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

• Job Function: Quality
• Job Sub Function: Quality Assurance
• Job Category: Professional

All Job Posting Locations: Raritan, New Jersey, United States of America

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

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.

Additional information

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check.

#LI-Hybrid

Preferred Skills

Business Alignment, Coaching, Collaboration, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility

The anticipated base pay range for this position is

$105,000.00 - $181,700.00

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation -120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year

Holiday pay, including Floating Holidays -13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

• Caregiver Leave - 80 hours in a 52-week rolling period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.

Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.