Associate Director, Quality Assurance
The Quality Assurance Associate Director is responsible for implementing and maintaining laboratory quality systems and procedures in compliance with all current FDA GMP regulations and guidance, as well as relevant ICH guidelines. This individual will oversee the Quality Assurance operations, quality systems and training program, and provide expertise and direction in relation to quality initiatives.
PRIMARY DUTIES AND RESPONSIBILITIES
- Responsible for the day-to-day and strategic functions of the Quality Assurance Department, including mentoring and supervising Quality Managers, developing individual/department goals/objectives, continually monitoring performance/conducting performance reviews, and ensuring the development of a functionally cross-trained organization.
- Serve as a liaison between clients and the laboratory, in order to effectively communicate quality procedures and systems.
- Effectively refine/direct/manage the Change Control program.
- Serve as a liaison for Boston Analytical inspections, including those conducted by clients, and inspections conducted by FDA or other regulatory authorities.
- Effectively create, approve, and direct the maintenance of all quality documentation, including Standard Operating Procedures.
- Manage and maintain a comprehensive CAPA program.
- Develop a system for surveillance inspections of audited projects for conformance to company and customer requirements.
- Work closely with other departmental leadership to achieve corporate and quality objectives.
- Provide management support for compliance activities as needed.
REQUIREMENTS & QUALIFICATIONS
Qualification include a degree in Chemistry or a related science is required with a minimum of 10 years of experience in a pharmaceutical quality assurance management role. Experience in FDA cGMP regulated analytical and/or microbiological laboratory settings. Fluent in current Agency guidance and ICH guidelines as they relate to cGMP operations, as well as demonstrated success in implementing systems complaint with these regulations and guidelines.
MINIMUM SKILLS REQUIREMENTS
- Extensive knowledge in FDA cGMP regulations and current industry practices.
- Demonstrated ability to mentor/manage/lead Quality Assurance personnel.
- Ability to multi-task and meet deadlines.
- Knowledge of the regulations of the Food and Drug Administration, compliance with Good Manufacturing Practices and pharmaceutical analyses is required.
- Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
- A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
- Must have excellent organizational, verbal communication and technical documentation skills.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.
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