Director/Sr. Director, Vendor Quality Management
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Director/Sr. Director managing vendor quality for BridgeBio Pharma. Leading qualification and oversight of contract manufacturers and partners in GxP activities.
Responsibilities:
- Reporting to the Vice President, Quality, the Director/Sr. Director, Vendor Quality Management provides strategic and operational leadership for the qualification, oversight, and performance management of contract manufacturers (CMOs), contract laboratories, suppliers, and service providers supporting GxP activities.
- Establish and maintain a risk-based vendor qualification and requalification program
- Define vendor risk classification criteria and oversight frequency
- Oversee vendor assessments and approval processes
- Monitor vendor performance through quality metrics
- Lead vendor transition or discontinuation activities as needed
- Oversee development and maintenance of Quality Agreements
- Ensure agreements clearly define roles and responsibilities
- Align Quality Agreements with business contracts
- Periodically review and update agreements
- Establish vendor performance metrics
- Conduct Quality Business Reviews with key vendors
- Implement risk-based monitoring strategies
- Proactively identify and mitigate compliance risks
- Ensure vendor oversight documentation supports inspection readiness
- Participate in regulatory inspections
- Coordinate vendor support during inspections
- Oversee remediation related to vendor findings
- Partner with CMC, Clinical Operations, Clinical Development, Supply Chain, Commercial, Regulatory, Legal and other functions as needed
- Provide vendor compliance risk expertise during program planning
- Support new product introductions and technology transfers as needed
- Benchmark vendor oversight practices
- Drive digital enablement of vendor management systems
- Promote proactive quality culture across partner network
Requirements:
- Bachelor’s degree in scientific discipline or equivalent experience
- 12+ years of pharma/biotech quality experience with vendor oversight
- Strong knowledge of cGMP and global regulatory expectations
- Experience managing vendor audit programs
- Experience drafting and negotiating Quality Agreements
- Experience supporting regulatory inspections
- Strong risk assessment and collaboration skills
- Travel: ~25–35%
Benefits:
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Report this job
Job expired or something wrong with this job?
Similar Jobs
Director of Revenue Cycle Management
Director of Revenue Cycle Management at BetterHelp leading a team and optimizing healthcare reimbursement processes. Focused on operational excellence and collaboration across departments for improved results.
Site Director
Site Director leading High NA EUV initiatives at Micron's NYCreates site. Responsible for engineering team development and technology enablement in semiconductor processing.
Director, Digital Programs
Director overseeing digital client portfolio for healthcare data solutions at Datavant. Leading program managers to ensure successful strategy implementation and operational excellence.
Deal Desk Director
Deal Desk Director working with Global Sales Organization at Azul. Providing support and guidance in deal aspects, enforcing contracting standards, and collaborating cross-functionally.
Director of Capital Raising, Investor Relations
Director of Capital Raising leading capital fundraising initiatives for a commercial real estate company. Generating new investor relationships and managing investor communications remotely.
Director of Nursing, Traveling DON
Director of Nursing managing nursing services in senior living facilities. Ensuring quality care and supervision for residents in accordance with physicians' orders.
Director, Partner and Alliances – Commerce
Partner Director managing Verndale partner channel relationships to drive results through innovation and teamwork. Engaging with partners to ensure successful execution of sales plans.
Director, Channel
Director of Channel Sales at Vultr driving channel revenue through partnerships in AI and Cloud Computing. High visibility role requiring leadership in pipeline creation and strategy execution.
Associate Director, Senior Study Lead – Single Sponsor Dedicated
Associate Director Senior Study Lead leading cross-functional clinical trial teams at IQVIA. Ensuring operational excellence in clinical studies while navigating a matrix environment.
Director, Advocacy Strategy and Engagement
Director, Advocacy Strategy overseeing mobilization functions for YMCA of the USA. Leading advocacy strategy and outreach to engage target audiences and elected officials.
Director of Creative Services
Director of Creative Services at Big Leap leading an internal creative team. Ensuring high-quality delivery of SEO content and digital marketing assets in a client-focused environment.
Director, Oncology Field Medical Outcomes
Oncology Medical lead providing therapeutic insights for Pfizer's Oncology portfolio. Collaborating with healthcare decision makers to enhance patient care through evidence-based strategies.
Vaccines Field Medical Director, MD
Vaccines & Antivirals Field Medical Director at Pfizer providing expertise and executing strategy for medical stakeholders. Responsible for engaging external medical stakeholders and optimizing patient care through education.
Vaccines Field Medical Director – non-MD
Vaccines Field Medical Director managing medical strategy and engagement with healthcare stakeholders for Pfizer. Requires strong expertise in health sciences and significant experience in related fields.
Associate Statistics Director
Associate Statistics Director in Advanced Analytics working with applied statistical techniques and AI in a collaborative environment. Responsible for model development and team coaching.
Senior Director, Practice Lead – AAA Staff Aug
Senior Director, Client Delivery at Sureify responsible for overseeing client relationships and solution delivery execution. Leading high-performance teams, enhancing client satisfaction, retention, and growth.
Director, Mass and Club – Target, Costco
Director of strategic sales plans for Mass and Club channels at Liquid Death. Leading relationships with Target and Costco to ensure profitable growth.
Board Member
Board Member providing governance and strategic direction for small businesses in Alberta. Overseeing financial health, supporting fundraising efforts, and contributing to committee meetings.
Associate Director, Medical Information
Associate Director, Medical Information leading strategy and operational standards at Cogent Biosciences. Focused on launch readiness and cross-functional collaboration within the organization.
Director, US Health Economic Value Access – HEVA
Director of Health Economic Value Access at Iovance Biotherapeutics. Leading pricing strategies and economic evidence development for market access in the US healthcare sector.