Jason Johal at CK Science is currently recruiting for a QA Service Provider Strategy Lead to join one of the world’s leading research-focused healthcare groups for at their Hertfordshire site on a full time, permanent basis.
This role monitors activities outsourced to Service Providers through periodic risk assessment, risk-based routine audits and provides ongoing support to mitigating actions. It also provides actionable data to Senior Procurement/Outsourcing functional management based on analysis of data (audit/inspection/risk) and identification of trends.
Responsibilities
Joining the international Product Development Quality Assurance (PDQA) team, this position will be assigned to the Laboratory service category (GLP, GCP). Reporting to the Principal Team Lead for Service Provider QA Strategy the ideal candidate will be responsible for the design and implementation of the Service Provider risk management and audit strategy across the GLP, GCP, GPVP areas. The role works in partnership with Procurement/Outsourcing Functions and the PDQA GLP, GCP, PV Strategy Leads to ensure that Risk Assessments are maintained across the inventory of Service Providers engaged globally (gRED, pRED, PD, GPS/gMED) and at Affiliate Level.
As QA Service Provider Strategy Lead you will:
- Design and implement the PDQA Service Provider risk-based strategy for risk management and audit activities
- Define/maintain the “audit/risk universe” of Service Providers based on input from Procurement/Outsourcing functions and PDQA GxP Strategy Leads
- Partner closely with the GxP Strategy Leads, Procurement/Outsourcing Functions to ensure that risk assessments are maintained for Service Providers to determine which audits will be conducted and where risk mitigation activities should occur.
- Develop and implement a GxP risk based strategy to deliver an audit program and quality oversight model for service providers within service category areas.
- Assess specific risk areas on an on-going basis, communicate to PDQA senior leadership and propose modifications to PDQA strategy where necessary
- Assess data/metrics from audits, inspections and risk management activities for compliance trends and risks
- Develop communication tools (reports/dashboards) for audit and inspection metrics and trends
- Support regulatory authority GCP inspections at service providers
Qualifications
The successful QA Service Provider Strategy Lead will have the following qualifications, skills & experiences:
- Bachelor’s degree or equivalent in a scientific or quality related field or equivalent combination of education, training and experience
- Extensive experience in the pharmaceutical industry and/or quality assurance with excellent knowledge of a GLP or Pharmacovigilance Service Provider Quality role
- Demonstrated knowledge of GLP, GCP, CSV, PV / drug safety and regulatory requirements
- Project management experience with proven leadership, mentoring and coaching skills
- Experience supporting Service Provider sourcing initiatives and/or representing QA on Service Provider Strategic Alliance or Category governance teams
- Proficiency in the conduct of GxP related audits of Service Providers
- Experience supporting regulatory authority inspections
Benefits
If successful, you will be joining a QA Service Provider Strategy Lead. In return there is:
- Attractive salary
- Excellent benefits
- Career progression opportunities
How to apply
To apply for this QA Service Provider Strategy Lead position contact Jason Johal via email: jjohal@ckscience.co.uk or telephone: 01438 723 500. Please quote reference ST25997 in all correspondence. Entitlement to work in the EEA is essential.
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