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Job Description - Director of Quality Assurance
Description: We are looking for a motivated individual with the professionalism and sensitivity to successfully interact with diverse individuals. This person must possess adaptability and enthusiasm to proactively contribute, take initiative and work with minimal supervision.
This person will provide leadership during implementation and, subsequently, for ongoing support of company quality and document control systems and compliance including SOPs development, auditing, training, quality investigations, etc. Manage, lead and direct a small team to support these functions.
Extensive knowledge of QA systems and cGMP rules and regulations required. This person needs to have demonstrated abilities to work effectively with senior leaders from many different functions to appropriately establish compliance, documentation needs, and training requirements for diverse parts of the organization. Specific duties include:
Oversee and supervise all quality aspects of activities worldwide including GMP compliance of manufacturing operations, GLP requirements of toxicology studies and GCP compliance of the clinical development programs.
Develop and oversee the auditing program for GCP, GMP, and GLP compliance involving a variety of vendors (contract manufacturers, analytical testing labs, preclinical labs, packaging and labeling facilities, CROs, EDC providers, central labs, clinical sites, etc. ).
Develop program for assuring compliance with 21 CFR Part 11.
Continue to develop and maintain internal company SOP's and organize the annual/periodic SOP reviews.
Establish, develop and oversee employee training program and training records.
Work with Finance/Admin. group and Sr. Management to develop and implement a corporate quality assurance function.
Oversee release of clinical drug substances and drug products.
Develop and implement program f |
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