What are the responsibilities and job description for the Manager of Quality Assurance Operations position at Proclinical?
Manager of Quality Assurance Operations - Contract - Cambridge, MA
Proclinical is seeking a Manager of Quality Assurance Operations to join a dedicated team.
Primary Responsibilities :
This role will assist with all GMP aspects of drug product manufacturing and alliance management. The successful candidate will work closely with Quality Operations to ensure that clinical and commercial lifecycle activities comply with cGMP regulatory requirements. This position involves collaboration with internal and external partners to maintain high-quality standards.
Skills & Requirements :
- Degree in life sciences, engineering, or related field.
- Minimum of 5 years experience in Quality Assurance within pharmaceutical or biopharmaceutical companies.
- Familiarity with external Contract Manufacturing Organizations in a virtual setting.
- Knowledge of aseptic techniques and parenteral drug manufacturing operations.
- Experience with GMP management and exposure to regulatory authorities like FDA, EMA, PMDA, or ANVISA.
- Preferred experience with investigational and commercial products in Quality Operations.
- Experience working with Alliance Partners is a plus.
- Ability to improve processes and turnaround times.
The Manager of Quality Assurance Operations' responsibilities will be :
