Vertex ยท 2 months ago
Associate Director, Vendor Quality Management (Hybrid)
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$148K/yr - $221K/yr
8+ years expVertex is a global biotechnology company that invests in scientific innovation. The Associate Director, Vendor Quality Management is responsible for monitoring vendor quality and compliance risk in GxP regulated environments, developing vendor data analytics, and driving continuous improvement in vendor quality processes.
Computer Software
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
Qualification
Required
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
Benefits
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)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase