ViiV Healthcare (GSK) Operational Quality and Training Director

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ViiV Healthcare (GSK) Operational Quality and Training Director

Site Name: Durham Blackwell Street, UK - London - New Oxford Street
Posted Date: Jan 15 2025

ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. Our aim is to think, act, and connect differently through a focus on education on and treatment for HIV. We go to extraordinary lengths to deliver breakthroughs in treatments, care solutions, and communities. We are fully committed to push through every challenge until HIV/AIDS is eradicated.

As the Operational Quality and Training Director, you will be responsible for delivering Operational Quality for ViiV R&D and Training Oversight and Management to ViiV as the single point of accountability for ViiV Clinical Development. You will ensure delivery of a consistent, uniform, and effective management monitoring programme that provides assurance that clinical trial activities governed by GCP and related regulations undertaken by ViiV are compliant with ViiV policies/procedures and are conducted in accordance with accepted principles for clinical trial research. You will also be responsible for ensuring the agreed compliance training strategy is in place, in use, and effective in ViiV, working across RDGM functions to deploy standard business processes and drive improvements in compliance learning while ensuring the organization meets regulatory requirements.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. Responsibilities include:

Operational Quality

• Define strategy and methodology for risk-based Management Monitoring (MM); create an annual MM plan to ensure inspection readiness and periodically review the outcomes of MM.
• Provide oversight of VH CAPAs to completion including ensuring all CAPAs have current, relevant owners assigned and engaged.
• Provide oversight of Management Monitoring (MM) of CAPA actions including the provision of effectiveness checks, where appropriate.
• Provide RDGM LT with reports of CAPA completion data (late, near due, due later) including at-risk CAPAs.
• Support preparation activities and the management of Regulatory Inspections for Development programmes.
• Lead Root Cause Analysis for MM or VH GCP Audits.
• Maintain contemporary knowledge in the evolving regulatory expectations.

Training

Accountable for the design, implementation, and maintenance of the RDGM curricula:

• Responsible for annual RDGM curriculum review.
• Responsible for ad-hoc curriculum revisions (addition or retirement of courses and/or curriculum creation).
• Responsible for the authorship, co-authorship, course creation, revision, and/or retirement for >90% of courses.

RDGM single point of contact for training and SOPs:

• Liaise with GSK myLearning team to ensure proper identification and application of GSK training and ensuring relevance and applicability of KPIs.
• Single point of contact for GSK Simplification SOP process.
• Deliver annual review of adopted GSK service provider SOP.

Audit/Inspection readiness, preparation and CAPA management

• Accountable for organisational process oversight via the analysis and provision of metrics and functionality reports for key governance meetings.

Why you?

Basic Qualifications:

• Bachelors' degree in a Scientific discipline & 5 plus years Quality Assurance OR Risk Management experience within the Pharmaceutical Industry.
• 5 plus years of experience with regulatory guidelines worldwide, including EMEA, ICH, and FDA regulations.
• Scientific/pharmaceutical/vaccines industry experience in research and development.
• Experience in Quality Assurance and Risk Management areas, including root cause analysis.
• Experience with drug/vaccines development and clinical processes.

ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.