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Post: Bioresearch Quality & Compliance Pharmacovigilance Manager
Job Description:
The BioResearch Quality & Compliance (Q&C) Pharmacovigilance Manager independently leads the planning, conduct and reporting of BioResearch Q&C routine and non-routine Pharmacovigilance (PV) 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. to ensure the quality of company-sponsored R&D and post-marketing pharmacovigilance activities within the regions (Americas, Europe, Middle East & Africa (EMEA), Asia Pacific). Leads or contributes to other project initiatives within the organization. Serves as subject matter expert in Pharmacovigilance and/or one or more compliance disciplines or areas (e.g. GLP, GCP, computerized systems, non-regulated area) and acts as a contact for internal and/or external stakeholders.
Key responsibilities
- Independently leads the planning, conduct and reporting of BioResearch Q&C routine and non-routine PV audits/assessments/inspections of activities, data, internal facilities and processes 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. Manages complex or business critical audits/issues in a supporting or leading role.
- Supports BRQC auditors and Quality Process Liaison in planning, conduct, reporting and follow-up of Consumer PV audits. Conducts Peer review of audit reports.
- Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
- Participates in regulatory inspections in a leadership role (e.g. host, backroom lead). Identifies training needs and facilitates training for Consumer auditees.
- Develops and provides training.
- Independently advises and coaches other auditors.
- Completes training requirements in a timely manner to ensure inspection readiness at all times.
- Leads initiatives and actively participates in key projects.
- Interacts with key stakeholders and is able to influence and effectively drive projects to completion.
- Actively shares business area and regulatory knowledge/expertise for the PV/Safety community within Consumer.
- May act as a primary contact for internal and/or external stakeholders. Independently provides consultation and advice to Business Partners and the core business sector on quality and compliance processes/procedures, specifically as it relates to PV and safety related activities.
- Interprets and applies regulations/policies to unique and/or complex issues, when required.
- Provides strategic input during the development of processes/procedures.
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Qualifications REQUIREMENTS:
- A minimum of a Bachelor’s Degree is required.
- A minimum of 5 years in an R&D, PV and/or quality and compliance area required.
- An advanced degree (MSc or above) is preferred.
- Thorough knowledge of the drug development process and regulatory framework globally of PV/Safety required. Expertise in GVP and one or more specific compliance disciplines (GLP, GCP) required. Knowledge of procedural and records management requirements in a regulated industry required.
- Prior pharmaceutical, consumer personal products and quality/compliance related experience preferred.
- Knowledge of auditing techniques required.
- 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.
Additional Information:
Experience: 5 years
Qualification: B.Pharm, B.Sc
Location: India
Functional Area: R&D
Industry Type: Pharma/Biotech/Clinical Research
Requisition ID: 1600099498W
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