What are the responsibilities and job description for the Senior Director Quality Assurance GCP position at Proclinical Staffing?
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.
Salary : $200,000 - $260,000
