Pharmacovigilance - Lead Specialist Abuse Potential

Johnson & Johnson is currently recruiting for a PV Auditor - Lead Specialist APAC (New Consumer Health Company). This position will be located in Shanghai, China or Singapore.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science bringing innovative ideas, products and services to advance the health and well-being of people.

With $82.1 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

The Bioresearch Quality & Compliance (Q&C) Pharmacovigilance Auditor - Lead Specialist independently leads the planning, conduct, and reporting of routine/non-routine Good Pharmacovigilance Practice (GVP) audits/assessments and supports inspections of the J&J Consumer sector worldwide, including J&J Consumer Local Operating Companies, partners and service providers. These audits/assessments/inspections provide an independent quality assessment to ensure compliance with appropriate regulations, SOPs, processes, etc. as they pertain to company-sponsored R&D and post-marketing pharmacovigilance activities, within the regions (Americas, Europe Middle East & Africa (EMEA), Asia Pacific). Also contributes to or may lead to other compliance and quality activities, as assigned.

**Roles and Responsibilities**:

- Independently lead the planning, conduct, and reporting of BRQC routine and non-routine audits of activities, data, internal facilities, and processes in GVP to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements
- Non-routine audits include Due Diligence, for-cause audits, and cross-functional, system/service provider audits as defined by the scope
- Support other auditors in planning, conducting, and reporting of audits
- Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities
- Participates in regulatory inspections in core and supporting roles
- Assists in the preparation and delivery of training materials
- Advises and contributes to coaching
- Completes training requirements in a timely manner to ensure inspection readiness at all times
- Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate
- Meets priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress
- Provides expertise and knowledge to less experienced auditors, Business Partners, and the core business sector on quality and compliance processes/procedures
- Interprets and applies regulations/ policies to issues of moderate complexity, when required.

**Qualifications** Position Requirements**:

- Expertise in Good Pharmacovigilance Practice
- Comprehensive knowledge of the drug development process, R&D practices, regulatory quality requirements, and/or post-marketing surveillance of drugs, medical devices
- Knowledge of procedural and records management requirements in a regulated industry
- Prior pharmaceutical, consumer personal products, and quality/compliance-related experience
- Knowledge of auditing techniques
- Must have excellent communication skills and be fluent in written and spoken English
- Must be a team player, organized, detail-oriented, and possess sound problem solving, conflict resolution, and good negotiating skills
- Must be able to work with a high level of independence and be able to train/coach others with regard to interpretation of regulatory requirements and compliance activities, and project management to ensure the timely and accurate completion of quality & compliance activities
- Bachelor’s Degree or equivalent
- Minimum 6 years experience in the pharmaceutical industry

**Preferred Requirements/Competencies**:

- Experience working in a Quality or Regulatory organization
- Expertise in one or more specific compliance disciplines (GLP, GCP) preferred
- Quality Auditor in Good Pharmacovigilance Practice, Good Manufact