Director, R&D Vendor Governance

Proclinical is seeking a Director of R&D Vendor Governance for a leading biopharmaceutical company located in Boston, MA. As the Director, R&D Vendor Governance, you will be responsible for the delivering a pragmatic model for vendor governance, driving quality-quality partnership with key vendors, overseeing the execution of quality agreements, and monitoring and management of R&D vendor risks, among other activities.

Job Responsibilities:

• Serves as a strategic partner to R&D Quality, the Global QMS and Compliance organization, business vendor management leads, strategic sourcing, and other stakeholders in defining and delivering effective and pragmatic quality governance for R&D vendors, informed by global quality vendor management processes, development timelines, product/service launches, and customer needs, expectations and prioritization.
• In collaboration with functional and quality partners, determines appropriate level of quality governance for R&D vendors and vendor engagements based on risk and oversees team in executing on this strategy.
• In collaboration with functional partners. R&D quality partners, Legal and others, defines R&D specific components of quality agreements and oversees team in negotiating, executing, and as necessary, updating quality agreements for R&D vendors, where required.
• Partners with functional and quality teams to define ongoing and pragmatic vendor oversight approaches for vendors based on risk and in establishing robust R&D-specific vendor quality performance metrics (e.g. KQIs) across contracted R&D activities
• Establishes strategy for periodic engagement with quality partners at vendors to drive improvement where required and to capitalize on opportunities for strategic quality-quality partnership.
• Oversees a high performing vendor governance team that seeks out, integrates, and translates data and insights across programs and activities supported by a vendor into a coherent profile of vendor quality performance and compliance.
• Ensures timely and effective communication of a composite scorecard of vendor risk, including both global and R&D-specific components, as well as other summary data on vendor performance to relevant partners
• Defines and oversees team in carrying out proactive inspection readiness activities related to vendors and their oversight. Provides insights about vendor risk that inform audit planning, inspection readiness, and governance strategies employed by quality counterparts in audit and inspection management and operations.
• Participates in external initiatives and industry forums related to quality oversight of vendor and translates insights into strategic improvements for R&D Quality and relevant business partners.
• Provides direction, oversight, coaching and mentoring to direct reports. Creates a culture of inclusiveness, partnership, opportunity, development, engagement, and performance for direct reports and more broadly across QA

Skills and Requirements:

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 10 years of relevant experience in a pharmaceutical, medical device or biologics company, and 3 years of supervisory/management experience, or the equivalent combination of education and experience.
• Thorough knowledge of global regulatory requirements (FDA, EMA, ICH & country specific regulations and other relevant guidance governing GxP activities)
• Contemporary knowledge of current industry trends, standards and methodologies as it relates to GxP vendor practices.
• Strong understanding and ability to implement risk management fundamentals/tools, especially as it relates to vendor management.
• Demonstrated ability to effectively communicate orally and in writing and influence the outcome of the decision making process
• Excellent interpersonal skills. Ability to lead global quality improvement efforts and drive harmonized, fit for purpose approaches across GxP areas.
• Proven ability to manage projects/team of significant scope and complexity, while meeting deliverables and timelines
• Displays highly effective coaching and people management abilities as well as a successful track record of developing junior staff

If you are having difficulty in applying or if you have any questions, please contact Jason Lawrence at (+1) 646-779-7968 or j.lawrence@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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