Quality Assurance Consultant
Posted 1 day ago by eTeam
Negotiable
Undetermined
Undetermined
United Kingdom
Summary: The role of QA Consultant focuses on providing expertise in Pharmacovigilance Quality Assurance within a regulated pharmaceutical environment. The consultant will be responsible for maintaining quality systems, conducting audits, and ensuring compliance with regulatory standards. This position requires collaboration with various stakeholders to drive continuous improvement initiatives and support global quality activities. Occasional international travel for audits may be required.
Key Responsibilities:
- Plan, conduct and report regional, cross-regional and global audits
- Manage audit schedules and deliver multiple audit programmes simultaneously
- Liaise with stakeholders regarding audit findings and recommendations
- Conduct root cause analysis and identify continuous improvement opportunities
- Monitor and follow up audit findings through to closure
- Provide expert GPvP and quality assurance guidance to stakeholders
- Support interpretation and implementation of regulatory requirements
- Coach and mentor colleagues on QA processes and best practices
- Identify compliance risks and recommend mitigation strategies
- Support inspection readiness and quality improvement initiatives
- Support development, maintenance and enhancement of quality management systems
- Investigate quality issues, critical non-conformances and compliance concerns
- Lead CAPA development, implementation and effectiveness reviews
- Drive continuous improvement initiatives across pharmacovigilance and related functions
- Ensure quality processes align with regulatory expectations and industry best practices
- Maintain effective relationships with service provider QA teams
- Support quality oversight activities for external vendors and partners
- Assess and mitigate quality and compliance risks associated with third-party providers
- Ensure appropriate governance and quality controls are maintained
- Develop, analyse and report quality metrics and KPIs
- Prepare management reports and compliance updates
- Support quality trend analysis and risk assessments
- Provide data-driven recommendations to support business decisions
Key Skills:
- Bachelor's Degree or equivalent
- Minimum 7 years' experience in Pharmacovigilance Quality Assurance (PVQA), Clinical Quality Assurance, Pharmacovigilance/Drug Safety functions
- Strong knowledge of Good Pharmacovigilance Practice (GVP/GPvP), Good Clinical Practice (GCP), Quality Management System, Regulatory compliance requirement
- Experience conducting and leading audits
- Strong CAPA and root cause analysis experience
- Excellent stakeholder management and communication skills
- Ability to influence and collaborate across multiple functions
- Strong project management capabilities
- Excellent attention to detail
- Flexible and adaptable approach
- Advanced degree (MSc, PhD or equivalent) preferred
- Quality Assurance or Auditing certification preferred
- Experience working within global pharmaceutical or biotechnology organisations preferred
- Experience managing international audit programmes preferred
- Experience supporting regulatory inspections and compliance activities preferred
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
QA Consultant (Pharmacovigilance Quality Assurance)
Duration: 12-Month Contract
Start Date: ASAP (approximately 3-week onboarding process)
Travel: Occasional international travel may be required for audits (approximately once per year)
About the Role
We are seeking an experienced Quality Assurance Consultant with strong Pharmacovigilance Quality Assurance (PVQA) expertise to support global quality and compliance activities within a highly regulated pharmaceutical environment .This role will focus on maintaining and improving pharmacovigilance quality systems, conducting audits, providing quality consultancy, supporting regulatory compliance, and driving continuous improvement initiatives across global operations .The successful candidate will work closely with cross-functional stakeholders to ensure compliance with national and international pharmacovigilance requirements, quality standards, and regulatory expectations.
Key Responsibilities
- Audit Management
- Plan, conduct and report regional, cross-regional and global audits
- Manage audit schedules and deliver multiple audit programmes simultaneously
- Liaise with stakeholders regarding audit findings and recommendations
- Conduct root cause analysis and identify continuous improvement opportunities
- Monitor and follow up audit findings through to closure
- Analyse audit trends and identify lessons learned
- Quality Assurance Consultancy
- Provide expert GPvP and quality assurance guidance to stakeholders
- Support interpretation and implementation of regulatory requirements
- Coach and mentor colleagues on QA processes and best practices
- Identify compliance risks and recommend mitigation strategies
- Support inspection readiness and quality improvement initiatives
- Quality Systems & Compliance
- Support development, maintenance and enhancement of quality management systems
- Investigate quality issues, critical non-conformances and compliance concerns
- Lead CAPA development, implementation and effectiveness reviews
- Drive continuous improvement initiatives across pharmacovigilance and related functions
- Ensure quality processes align with regulatory expectations and industry best practices
- Vendor & Third-Party Oversight
- Maintain effective relationships with service provider QA teams
- Support quality oversight activities for external vendors and partners
- Assess and mitigate quality and compliance risks associated with third-party providers
- Ensure appropriate governance and quality controls are maintained
- Reporting & Performance Monitoring
- Develop, analyse and report quality metrics and KPIs
- Prepare management reports and compliance updates
- Support quality trend analysis and risk assessments
- Provide data-driven recommendations to support business decisions
Essential Requirement
- Bachelor's Degree or equivalent
- Minimum 7 years' experience in: Pharmacovigilance Quality Assurance (PVQA), Clinical Quality Assurance, Pharmacovigilance/Drug Safety functions
- Strong knowledge of: Good Pharmacovigilance Practice (GVP/GPvP) Good Clinical Practice (GCP) Quality Management System Regulatory compliance requirement
- Experience conducting and leading audits
- Strong CAPA and root cause analysis experience
- Excellent stakeholder management and communication skills
- Ability to influence and collaborate across multiple functions
- Strong project management capabilities
- Excellent attention to detail
- Flexible and adaptable approach
Preferred Experience
- Advanced degree (MSc, PhD or equivalent)
- Quality Assurance or Auditing certification
- Experience working within global pharmaceutical or biotechnology organisations
- Experience managing international audit programmes
- Experience supporting regulatory inspections and compliance activities