BioResearch Quality & Compliance Pharmacovigilance Auditor Job

Job description

BioResearch Quality & Compliance Pharmacovigilance Auditor-0000104CDescriptionJohnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a BioResearch Q&C Pharmacovigilance Auditor
- Senior Specialist, based in one of the following locations: Skillman, NJ; Morris Plains, NJ; Fort Washington, PA; Maidenhead, UK; Guelph, Canada.
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
The Bioresearch Quality & Compliance (Q&C) Pharmacovigilance Auditor – Senior 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 Operating Companies (including Consumer for pharmacovigilance), 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 other compliance and quality activities, as assigned.
Key responsibilities include, but are not limited to, the following: Independently leads 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, cross-functional, system/service provider audits as defined by the scope. May support 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. Participates in regulatory inspections in core and supporting roles. Assists in 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.
QualificationsA minimum of a Bachelor’s Degree is required. A minimum of 3 years of experience in quality and/or compliance is required. Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology is required. Expertise in GVP regulations and one or more specific compliance disciplines (GLP, GCP) preferred. Knowledge of procedural and records management requirements in a regulated industry preferred. Prior pharmaceutical, consumer personal products and quality/compliance related experience preferred. Must have excellent communication skills and be fluent in written and spoken English. Must be a team player, organized and detail oriented, and possess sound problem solving and good negotiating skills. Must be proficient in Microsoft Office applications and possess a Quality mindset.
This position requires overnight travel, nationally and internationally, up to 40%.BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NAPrimary Location:North America-United States-New Jersey-SkillmanOther Locations:North America-Canada-Ontario-Guelph, Europe/Middle East/Africa-United Kingdom-England-Maidenhead, North America-United States-Pennsylvania-Fort Washington, North America-United States-New Jersey-Morris PlainsOrganization: J & J Consumer Inc. (6101)Job Function: R&DCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement