Apply For Bioresearch Quality & Compliance Pharmacovigilance Manager Post @ Johnson & Johnson
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson’s Family of Companies, is recruiting for a BioResearch Quality & Compliance Pharmacovigilance Manager, based in Singapore.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.
Requisition ID : 1600099498W
Job Title : Bioresearch Quality & Compliance Pharmacovigilance Manager
Job Description :
- 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 include, but are not limited to:
-
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.
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.
This position requires overnight travel, nationally and internationally, up to 30%.
The hired candidate will continue to be based in his/her home country. No relocation support will be provided for this role.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
