Senior Director Quality Assurance GCP - Permanent - Cambridge, MA

Proclinical is seeking a dedicated professional for the role of Senior Director Quality Assurance GCP.

Primary Responsibilities:

The successful candidate will focus on enhancing and overseeing quality processes within a dynamic and evolving environment. You will collaborate with clinical and nonclinical teams to manage vendor networks and establish robust GCP/GVP/GLP standards, supporting future growth and development.

Skills & Requirements:

• Strong attention to detail with a focus on continual improvement.
• Team-oriented, flexible, and solution-focused with excellent communication skills.
• Ability to engage in all aspects of the role, from strategic to operational tasks.
• Bachelor's degree in a scientific field.
• Extensive experience in Quality Assurance within the pharmaceutical or biotech industry.
• Proficient in building GCP, GVP, and GLP systems and processes.
• Experience with Phase 3 trials and inspection readiness programs.
• In-depth knowledge of relevant quality regulations and risk management practices.

The Senior Director Quality Assurance GCP's responsibilities will be:

• Provide expertise in GCP, GVP, and GLP compliance, offering consultation, training, and recommendations.
• Develop and implement standards and practices for project teams and vendor oversight.
• Ensure adequate Quality support for clinical and nonclinical programs, coordinating with the Head of QA.
• Conduct risk assessments, audits, and identify process improvements.
• Oversee internal audits, provide metrics, and develop corrective actions.
• Support inspection readiness and manage quality investigations.
• Collaborate with Quality Management Systems colleagues to ensure compliance.
• Analyze and present quality metrics, recommending actions as needed.
• Review GCP/GCLP/GVP documentation and regulatory submissions.

Compensation:

• $ 200 000.00 - 260 000.00 Per Annum

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.