MANAGER QA PV AUDITOR

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anssen.
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Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Diversity & Inclusion are crucial to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.
Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions! Are you ready to join our team? Then read further! The Pharmacovigilance Quality Assurance Manager.
Actively shares business area and regulatory knowledge/expertise and 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.
Key Responsibilities.
Auditing · Independently leads the planning, conduct, reporting of RnD QA routine and non-routine audits of processes, internal organizations like Operating Companies, External Partners (e.
.
distributors, External Service Providers, Marketing Partners) in Pharmacovigilance area to assure adherence to corporate policies, internal standards/requirements, compliance with applicable regulatory requirements and contractual obligations.
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.
.
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 Deputises 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.
Qualifications 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 5-10 years of relevant work experience is required with at least 2 years of pharmacovigilance audit experience.
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.
., system audits Other.
Must be fluent in English.
This position requires % domestic and international travel.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
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