Associate Director, Vendor Quality Management (Hybrid)

Vertex Pharmaceuticals, Inc • Boston, MA

46d • Hybrid

About The Position

The Associate Director, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics, including but not limited to vendor key performance indicators, vendor quality metrics, and a vendor risk scorecard, to QA and to key business partners at the enterprise and program levels. The role also drives continuous improvement in Vertex vendor quality processes and governance to assure Vertex remains adherent to regulatory expectations and supports QA operational quality oversight and management of complex vendor issues.

Requirements

• Demonstrated working knowledge and experience applying US and international/global regulatory requirements, associated guidance and standards applicable to drug, biologic, combination product, and/or device research, development, manufacturing, and distribution.
• In-depth knowledge of regulatory requirements specific to vendor selection and oversight in one or more GxP areas.
• Strong working knowledge of risk management and issue management, with a demonstrated ability to apply to third party suppliers carrying out GxP governed activities
• Strong oral and written communication and interpersonal skills to communicate difficult concepts and persuade others
• Strategic "big picture" thinking while maintaining ability to collaborate effectively and execute efficiently at a tactical level
• Strong analytical thinking skills, with the ability to translate data into risk-informed insights that drive decision-making.
• Experience advising, coaching or mentoring junior staff.
• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 8 years of relevant work experience, or the equivalent combination of education and experience.

Responsibilities

• Maintains and manages an innovative and risk-based model for quality oversight and management of GxP vendors across product modalities.
• Maintains up-to-date integrated quality and risk scorecards across GxP vendors.
• Partners with Quality and business stakeholders to ensure adequate quality processes, governance and quality oversight across GxP vendors
• Serves as a consultant to Vertex QA teams and business functions in identifying risk management strategies, selecting vendors and remediating complex vendor issues.
• In close partnership with Quality and business stakeholders, maintains and evolves vendor quality-related processes, procedures, and templates
• Monitors vendor metrics and dashboards for emerging trends across vendors and communicates insights to appropriate QA and business stakeholders.
• Drives awareness and application of evolving regulatory requirements and expectations for vendor management across GxPs and product modalities
• Partners with QA operational, audit, and inspection teams in sharing and aligning on risks, managing complex quality issues, implementing process improvements and driving quality outcomes, including inspection readiness
• Serves as an SME and participates in inspection preparation and management activities relevant to vendor processes, risk management and oversight.
• Identifies quality improvements to Vertex quality systems to maintain compliance and improve efficiency utilizing risk-based methodologies, as related to vendor management/vendor oversight.

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• medical, dental and vision benefits
• generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• educational assistance programs including student loan repayment
• a generous commuting subsidy
• matching charitable donations
• 401(k)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees