Overall responsibility for the management of the Quality Assurance department which includes managing the staff by providing guidance, training, and coaching .
Confirms all programs such as calibration, maintenance, and validation are in compliance with the cGMPs.
Directs all training to support cGMP activities in clinical and manufacturing operations.
Responsible for all audit functions within BPC. Acts as host to auditing personnel as required, ensure staff response to internal and external audit plans are maintained, conducted, reported and responded to in a timely manner.
Oversees the review process of batch records and testing documents confirming compliance with approved practices and procedures. Insures documentation suitability against regulatory standards, and provides input to IND and BLA submissions.
Oversees release of raw materials, intermediate and final product confirming compliance with SOPs, regulatory guidelines, commitments to regulatory agencies, and BLA filings.
Oversees tracking and trending of quality systems and presents information/reports to senior level management regarding the status.
Ensures all controlled documents and records meet cGMP requirements.
Develops processes and guidelines for quality system management and oversees continuous improvements to ensure enhanced compliance to cGMPs and evolving FDA expectations.
Interfaces with other Biotest sites with regard to policies, procedures, and regulatory compliance tools.
Identifies staffing requirements, as necessary.
Must have demonstrated experience in managing a total quality program in a pharmaceutical or biotechnology environment. Knowledge in and experience in the blood products industry preferred. High degree of computer, cGMP, and FDA regulation experience. Strong office applications, database and computer hardware; written and oral communication skills. Requires excellent interpersonal skills and ability to supervise, guide, train and coach others.
Ability to assess and discuss constructively, with multi-disciplinary departments and/or regulatory personnel, compliance oversight priorities and the interpretation of areas not specifically addressed in the applicable statues, without creation of excessive risk for the corporation.
Minimum of 10 years experience in the pharmaceutical or biotechnology industry; 5 years experience in leading a quality assurance function.