Senior Director, GCP Quality Oversight — Hybrid Boston

Bicara Therapeutics; Boston (MA); Hybrid; USD 150,000 - 180,000; Full time

Job summary

A biopharmaceutical company in Boston is seeking a Senior Director for GCP Quality Oversight. This pivotal role involves managing GCP activities for clinical trials, ensuring compliance with regulations and best practices. Candidates must possess a Bachelor's degree and at least 10 years of quality assurance experience within the pharmaceutical industry. Strong skills in audits and cross-functional collaboration are essential. This role offers a hybrid work schedule with flexible office attendance.

Qualifications

• 10+ years of experience in quality assurance in the pharmaceutical/biotech industry.
• Subject matter expert in GCP guidelines and FDA regulations.
• Certification in quality assurance (e.g., Certified Quality Auditor) is desirable.

Responsibilities

• Oversee compliance of clinical trial activities with GCP guidelines.
• Conduct reviews of study-related documentation.
• Plan and participate in internal audits and external inspections.
• Develop internal training programs on GCP regulations.
• Collaborate to identify and mitigate GCP compliance risks.

Skills

Quality Assurance

GCP Compliance

Audit Planning

Cross-Functional Collaboration

Risk Mitigation

Problem Solving

Education

Bachelor's degree in life sciences, pharmacy, or nursing

Job description

A biopharmaceutical company in Boston is seeking a Senior Director for GCP Quality Oversight. This pivotal role involves managing GCP activities for clinical trials, ensuring compliance with regulations and best practices. Candidates must possess a Bachelor's degree and at least 10 years of quality assurance experience within the pharmaceutical industry. Strong skills in audits and cross-functional collaboration are essential. This role offers a hybrid work schedule with flexible office attendance.