Associate Director, Vendor Quality Management R&D Quality and Medical Governance

Associate Director, Vendor Quality Management R&D Quality and Medical Governance

Gilead

Dublin, Ireland

Job Description

R&D Quality and Medical Governance (Q&MG) is seeking an Associate Director, Vendor Quality Management (VQM) to join our high-performing team that supports Clinical Development & Post Marketing programs at Gilead. In this role you will be responsible for providing quality advice, direction, and leadership for quality and compliance oversight of GxP vendors. You will partner closely with business functions in applying a risk-based approach to key vendor activities which include vendor qualification/requalification, issue escalation and governance. You will work closely with external quality groups to ensure vendor commitments & services meet Gilead standards and comply with regulations.

You will act as the R&D Quality Business Partner to assigned groups, such as Gilead R&D functions and vendors supporting Gilead R&D. You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Practices (GxP). You will educate assigned groups on Gilead quality policy and procedural standards, GxP regulations and other requirements.

You will provide expert advice on GxP risk minimization and mitigation. You will help business and vendor partners understand potential impacts of risk and alternatives to best address risk. You will also provide leadership support in escalating quality risks or issues. You will participate in and/or lead Quality forums, cross-functional teams and/or projects. You will act as the central point of contact for QMS-related communications to assigned groups; consolidating and channeling just-in-time information and resources to assist assigned groups. You will collaborate with other R&D Quality and Medical Governance groups to ensure just-in-time support and resources to assigned groups, including data integrity and analytics, training, audit, inspection, risk assessment and deviation/CAPA management support. You may represent Gilead in regulatory inspections. Where applicable, you will play a lead Quality role in R&D vendor qualification, selection, on-boarding, relationship management and governance.

Our VQM group within Q&MG needs someone with strong leadership skills, expert knowledge of the regulations governing drug development as well as deep vendor compliance & oversight experience. This role will focus on vendor oversight activities, is highly visible, requires strong relationship building skills and the ability to influence and negotiate with cross-functional stakeholders. Professionalism and the ability to represent Gilead’s reputation externally is critically important. An understanding of Quality Risk Management (QRM) principles, Pharmacovigilance experience, as well as a track record of leading process improvement projects is desirable.

You will be a part of an expert global Quality team that strives to be a trusted business partner and promotes a culture of Quality in all we do.

Primary Responsibilities

• Oversees comprehensive vendor quality oversight program which includes vendor risk assessments
• Quality Issue Management and governance for GxP vendors
• Leads quality participation in vendor qualification, selection, requalification and governance activities
• Interfaces with key internal business stakeholders and external groups including Vendors and
• Contract Research Organizations (CROs) Quality organizations
• Develops strong relationships with Gilead’s key vendors, creating a mindset of partnership and mutual respect
• Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical
• Governance on internal quality audits, regulatory agency inspections, risk assessments, deviations and CAPAs for vendor related activities
• Serves as an expert and provide guidance on and interpretation of GxP regulations, standards, and quality systems for internal stakeholders
• Assists in inspection readiness and preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings, as applicable
• Supports deviation identification, reporting, and CAPA development, as applicable
• Oversees effective vendor quality reporting to functional management and the Gilead Senior Leadership team. This includes presenting relevant vendor metrics, trends and quality risks at quality meetings & governance forums
• Lead and support development and ongoing management of Quality Agreements with key vendors
• As an expert, provide sound judgment and risk-based rationale to facilitate decision-making and support the development and execution of effective and comprehensive action plans to address quality and compliance risks
• Leads Quality-to-Quality (Q2Q) governance meetings and represents R&D Q&MG in Operational Management Team (OMT) meetings for key vendors
• Reviews vendor contractual language from a quality & compliance perspective
• Leads intra or interdepartmental teams as assigned, such as continuous improvement initiatives
• Supports overall R&D Quality & Medical Governance goals and objectives
• Understands current global and regional trends in regulatory compliance and has the ability to assess the impact of these requirements to the business
• Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors

Qualifications

• Bachelor’s degree with significant years; Master’s degree with several years of R&D quality assurance compliance experience in a highly regulated environment
• Must have GCP audit and compliance experience
• Proven experience in managing vendor quality programs and/or vendor relationship management
• Has effectively operated within Clinical Quality Assurance or similar function in a Biopharma sponsor organization
• Charismatic leader with strong relationship building skills, and ability to influence and negotiate with cross-functional stakeholders
• Effective verbal, written, interpersonal skills to include delivering presentations to executives
• Recognized as an expert resource on a range of quality topics
• Demonstrates leadership skills while working in fast-paced and changing environment
• Strong organizational & project management skills including the ability to prioritize and adapt to business needs while upholding compliance with regulations and company procedures
• Able to maintain a balance between being strategic and taking deeper tactical dives as needed
• Excellent task and time management skills (e.g., project planning, prioritization)
• Ability to travel up to 20%

Preferred

• Experience with GPV and eSystem regulations
• Understanding of principles for Quality Risk Management (ICH Q9, ICH E6 R2)
• Track record of leading process improvement projects
• Experience in developing KQIs and monitoring for compliance and trends

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