Associate Director GCP Quality - Audit & Inspection Management (Contract) 00011
Vertex Pharmaceuticals
Summary
The Associate Director in the GCP Audit & Inspection Management department is responsible for coordinating and/or conducting audits and inspection management for assigned activities. This role ensures adherence to GCP regulations, industry standards, and to Vertex policies, procedures, and quality standards as set forth in the Quality Management System.
Job description
This is a remote role, that requires travel (about once a month).
Key Duties & Responsibilities
- Executes routine and directed audits of GCP vendors, investigator sites and internal processes, as assigned
- Engages in preparation, support and follow-up activities for inspection readiness
- Supports due-diligence and business development activities, as requested
- Participates in collaborative review of impacted SOP/WI
- Assesses adequacy of audit responses, including corrective and/or preventive actions
- May participate on process improvement initiatives
- Provides cross-functional support across Vertex Quality Assurance team
- Experience working in VEEVA
Required Education Level
- Minimum level of education needed BS or BA degree
- Typically requires 8 years of experience or the equivalent combination of education and experience
Requirements
- BS or BA degree
- Typically requires 8 years of experience or equivalent combination of education and experience
- Experience working in VEEVA
- Knowledge of GCP regulations and industry standards
- Experience with audit and inspection management
- Experience with SOP/WI review
- Experience assessing corrective and preventive actions
Benefits
- Remote work
- Overtime eligible
Company overview
Vertex Pharmaceuticals is a global biotechnology company headquartered in Boston, Massachusetts, founded in 1989. The company specializes in discovering, developing, and commercializing transformative medicines for serious diseases, with a primary focus on cystic fibrosis (CF). Vertex has pioneered breakthrough therapies including TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, ORKAMBI, and KALYDECO, which collectively treat approximately 90% of CF patients. Beyond CF, the company has expanded its portfolio to include treatments for sickle cell disease, transfusion-dependent beta thalassemia, acute pain, and has robust clinical pipelines in APOL1-mediated kidney disease, type 1 diabetes, myotonic dystrophy type 1, and alpha-1 antitrypsin deficiency. Vertex employs approximately 6,100 people globally and maintains research facilities in San Diego, California, and Milton Park, Oxfordshire, England. The company is publicly traded on NASDAQ (VRTX) and is recognized as one of the industry's top workplaces, consistently earning accolades for its innovative culture and patient-focused approach to drug development.