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
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
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
MINIMUM SKILLS REQUIREMENTS
Extensive knowledge in FDA cGMP regulations and current industry
Demonstrated ability to mentor/manage/lead Quality Assurance
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.