Quality Product Complaints Associate Director
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
The Quality Product Complaints Associate Director provides quality oversight of the Product Complaint Quality System and the Global Recall and Defect Notification Systems. Supports Compliance quality activities and partners cross-functionally with Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations, and external call centers. Drives continuous improvement in Vertex quality processes and governance to ensure adherence to regulatory expectations and evolve the Product Complaints quality system.
Key Duties and Responsibilities:
- End-to-end ownership of product complaints process, including complaint handling accountability
- Identify new capabilities and deliver improvements; implement automation & AI solutions to enhance efficiencies and compliance robustness
- Maintain inspection readiness as steady state
- Lead complex/high-risk investigations; coordinate with CMOs for external investigations
- Perform Root Cause Analysis, identify Corrective Actions, and escalate critical issues to senior management
- Lead product complaints trending program, including adverse trend identification and investigation
- Support global recall and defect notification processes (mock recalls, SOP management, evaluation of regulatory intelligence)
- Proactively identify issues before reportable events/trends/regulatory findings; develop and apply risk thresholds and triggers
- Provide risk-balanced recommendations; understand decision-making boundaries
- Strengthen feedback loops into QA operations, MSAT, Device Engineering
- Reduce process complexity and integrate cross-modality efforts; own/report QMR/QLT data for responsible workstreams
Knowledge & Skills / Qualifications:
- Working knowledge of GMP and GDP and US/international regulatory requirements across multiple modalities
- Experience in product complaints, recalls, field alerts, defect notifications; risk management; event/quality issue management incl. CAPA and effectiveness checks
- Root cause analysis and investigation techniques; inspection readiness
- Strong oral/written communication, interpersonal, project management, technical writing, analytical and leadership skills
Education & Experience:
- BS/BA in scientific/allied health field (or equivalent) OR MS degree
- 5–8 years relevant experience (with MS) or 10+ years (with BS) or comparable background
Benefits / Application Instructions:
- Annual bonus and annual equity awards; range: $148,000–$222,000.
- Flex designation: Hybrid (remote up to 2 days/week) or On-Site (5 days/week with ad hoc flexibility).
The Quality Product Complaints Associate Director provides quality oversight of the Product Complaint Quality System and the Global Recall and Defect Notification Systems. Supports Compliance quality activities and partners cross-functionally with Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations, and external call centers. Drives continuous improvement in Vertex quality processes and governance to ensure adherence to regulatory expectations and evolve the Product Complaints quality system.
Key Duties and Responsibilities:
- End-to-end ownership of product complaints process, including complaint handling accountability
- Identify new capabilities and deliver improvements; implement automation & AI solutions to enhance efficiencies and compliance robustness
- Maintain inspection readiness as steady state
- Lead complex/high-risk investigations; coordinate with CMOs for external investigations
- Perform Root Cause Analysis, identify Corrective Actions, and escalate critical issues to senior management
- Lead product complaints trending program, including adverse trend identification and investigation
- Support global recall and defect notification processes (mock recalls, SOP management, evaluation of regulatory intelligence)
- Proactively identify issues before reportable events/trends/regulatory findings; develop and apply risk thresholds and triggers
- Provide risk-balanced recommendations; understand decision-making boundaries
- Strengthen feedback loops into QA operations, MSAT, Device Engineering
- Reduce process complexity and integrate cross-modality efforts; own/report QMR/QLT data for responsible workstreams
Knowledge & Skills / Qualifications:
- Working knowledge of GMP and GDP and US/international regulatory requirements across multiple modalities
- Experience in product complaints, recalls, field alerts, defect notifications; risk management; event/quality issue management incl. CAPA and effectiveness checks
- Root cause analysis and investigation techniques; inspection readiness
- Strong oral/written communication, interpersonal, project management, technical writing, analytical and leadership skills
Education & Experience:
- BS/BA in scientific/allied health field (or equivalent) OR MS degree
- 5–8 years relevant experience (with MS) or 10+ years (with BS) or comparable background
Benefits / Application Instructions:
- Annual bonus and annual equity awards; range: $148,000–$222,000.
- Flex designation: Hybrid (remote up to 2 days/week) or On-Site (5 days/week with ad hoc flexibility).