Pharmacovigilance Quality Assurance Manager

Johnson & Johnson Innovative Medicine; Raritan (NJ); On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Vacation 120 hours per year

Sick time 40 hours per year

Holiday pay

Job summary

Johnson & Johnson Innovative Medicine in Raritan, New Jersey, seeks a Pharmacovigilance Quality Assurance Manager to lead GxP audit programs across clinical and manufacturing activities. The role collaborates with global teams to ensure regulatory compliance and continuous quality improvement in PV processes.

The ideal candidate has 6+ years in a GxP environment with PV audit experience, strong project management and communication skills, and a willingness to travel up to 25% for inspections and

Qualifications

• 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 leading complex pharmacovigilance audit types (e.g., system audits).

Responsibilities

• Independently leads planning, conduct, and reporting of audits/assessments in GxP/non-regulated environments.
• Supports other auditors in planning, conduct, and reporting.
• Leads regulatory inspections in a leadership role when required.
• Identifies training needs and provides mentoring to auditors.
• Supervises junior auditors/contractors; deputizes for Team Lead.
• Leads initiatives and drives projects across the organization.

Skills

GxP Auditing

Pharmacovigilance Auditing

Project Management

Verbal & Written Communication

Teamwork & Analytical Skills

Education

Bachelor's degree in life sciences or related field

Job description

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

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

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):

• Canada - Requisition Number: R-097969
• Brazil - Requisition Number: R-097962

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

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.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

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 https://www.jnj.com/contact-us/careers. 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.

Required 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

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 :

$102,000.00 - $177,100.00

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)).

This position is eligible to participate in the Company’s long-term incentive program.

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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits