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 j.godden@proclinical.com

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.