Associate Director QA Pharmacovigilance (PV) Systems Strategy-00000RZ5
Description
Janssen
Janssen is an award winning research-based pharmaceuticals and healthcare company. The business is part of the Johnson & Johnson family of companies, one of the world’s largest healthcare companies and the most comprehensive and broadly based manufacturer of healthcare products.
An outstanding opportunity has become available for a candidate of the highest calibre with the ability to think and act with clarity in a fast-paced environment. This is a global strategic role that will drive enhanced compliance across Pharmacovigilance Systems in the Pharmaceuticals group through partnership with relevant business partners (primarily Global Medical Safety (GMS), Global Regulatory Affairs (GRA), Medical Affairs (MAF), Regulatory Compliance (RC) and Quality Processes (QP). The role will also include responsibility for the Consumer Sector PV systems strategy as detailed in the Service Level Agreement (SLA). The Associate Director QA PV Systems Strategy will manage cross functional complex issues and interface with management on a daily basis. Decisions made at this level will have significant implications for PV compliance across the product portfolios
The Role
The Associate Director QA PV Systems Strategy is responsible for the development and management of audit strategies and programs to ensure issues are identified and mitigated early, such that the functions, processes and systems and deliverables are compliant to Regulatory Authority, industry and company standards and regulations.
Key Responsibilities will include:
Develop with the key stakeholders audit strategies and Risk Assessment and Management Plans and translate them into Audit Plans and System Diagnostic Tools:
- Develop Strategic Audit- and Risk Plans based on the input of all relevant stakeholders (Regulatory Compliance, Business Partners, QA Operations, QA Regional Head(s), and QP)
- Independently create Audit Plans based on Strategic- and Risk Plan that ensures issues are identified early and company gets optimally prepared for future inspections (inspection readiness)
- Create and maintain for the applicable disciplines System Diagnostic Tools ensuring auditors have the right focus and investigate the key aspects of the business. This should allow us to evaluate whether functions, processes and systems and deliverables are compliant to Regulatory Authority, industry and company standards and regulations
The Candidate
As this key position reinforces the message that compliance is a company priority and has access to the resources needed to assure implementation of an effective compliance program we are looking for someone who is highly commited to quality with strong leadership and collaboration skills, able to handle conflict and work independantly. Although this position does not have any direct reports, collaboration and mentorship with the Global GxP Audit Execution teams and the QA Operations team as well as good communication are key factors for the success of this role.
Negotiation with business partners and regulatory investigators/inspectors during compliance inspections in close collaboration with R&D QA Regulatory Compliance is essential. They will need to partner with relevant Cross-Pharma internal/external groups worldwide as appropriate, to enhance knowledge and promote compliance with company standards, global pharmacovigilance regulations and guidelines, and current expectations of regulatory authorities. This includes being a liaison with regulatory representatives.
Qualifications
Education:
- Master’s degree or BS/BA with previous Pharmaceutical Industry experience. Requires a thorough knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques.
Related Experience:
- Ability to interpret data to inform action plans to improve performance.
- Experience in R&D process requirements to successfully drive R&D QA productivity, strategy optimisation, process improvements and efficiencies
- Ability to translate data into information and strategies into executable action plans.
- Extensive Pharmacovigilance experience
What type of mark will you make?
Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: Pharmacovigilance
Description
Janssen
Janssen is an award winning research-based pharmaceuticals and healthcare company. The business is part of the Johnson & Johnson family of companies, one of the world’s largest healthcare companies and the most comprehensive and broadly based manufacturer of healthcare products.
An outstanding opportunity has become available for a candidate of the highest calibre with the ability to think and act with clarity in a fast-paced environment. This is a global strategic role that will drive enhanced compliance across Pharmacovigilance Systems in the Pharmaceuticals group through partnership with relevant business partners (primarily Global Medical Safety (GMS), Global Regulatory Affairs (GRA), Medical Affairs (MAF), Regulatory Compliance (RC) and Quality Processes (QP). The role will also include responsibility for the Consumer Sector PV systems strategy as detailed in the Service Level Agreement (SLA). The Associate Director QA PV Systems Strategy will manage cross functional complex issues and interface with management on a daily basis. Decisions made at this level will have significant implications for PV compliance across the product portfolios
The Role
The Associate Director QA PV Systems Strategy is responsible for the development and management of audit strategies and programs to ensure issues are identified and mitigated early, such that the functions, processes and systems and deliverables are compliant to Regulatory Authority, industry and company standards and regulations.
Key Responsibilities will include:
Develop with the key stakeholders audit strategies and Risk Assessment and Management Plans and translate them into Audit Plans and System Diagnostic Tools:
- Develop Strategic Audit- and Risk Plans based on the input of all relevant stakeholders (Regulatory Compliance, Business Partners, QA Operations, QA Regional Head(s), and QP)
- Independently create Audit Plans based on Strategic- and Risk Plan that ensures issues are identified early and company gets optimally prepared for future inspections (inspection readiness)
- Create and maintain for the applicable disciplines System Diagnostic Tools ensuring auditors have the right focus and investigate the key aspects of the business. This should allow us to evaluate whether functions, processes and systems and deliverables are compliant to Regulatory Authority, industry and company standards and regulations
The Candidate
As this key position reinforces the message that compliance is a company priority and has access to the resources needed to assure implementation of an effective compliance program we are looking for someone who is highly commited to quality with strong leadership and collaboration skills, able to handle conflict and work independantly. Although this position does not have any direct reports, collaboration and mentorship with the Global GxP Audit Execution teams and the QA Operations team as well as good communication are key factors for the success of this role.
Negotiation with business partners and regulatory investigators/inspectors during compliance inspections in close collaboration with R&D QA Regulatory Compliance is essential. They will need to partner with relevant Cross-Pharma internal/external groups worldwide as appropriate, to enhance knowledge and promote compliance with company standards, global pharmacovigilance regulations and guidelines, and current expectations of regulatory authorities. This includes being a liaison with regulatory representatives.
Qualifications
Education:
- Master’s degree or BS/BA with previous Pharmaceutical Industry experience. Requires a thorough knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques.
Related Experience:
- Ability to interpret data to inform action plans to improve performance.
- Experience in R&D process requirements to successfully drive R&D QA productivity, strategy optimisation, process improvements and efficiencies
- Ability to translate data into information and strategies into executable action plans.
- Extensive Pharmacovigilance experience
What type of mark will you make?
Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: Pharmacovigilance