Site Quality Operation Leader
Global Pharmaceutical Company
This position will:
- Identify quality, process, and GMP problems and assure resolution.
- Manage overall process in evaluating site compliance to our Quality Standards (PQS) and implement appropriate actions.
- Manage the overall assurance and disposition of products produced at the manufacturing site or by approved vendors.
- Approve quality operations and production quality assurance reports and investigations for deviations from approved manufacturing processes or specifications.
- Review key quality and regulatory documentation and implement appropriate actions.
- Lead and engage the site quality review team (SQRT) and AQRT process to ensure site regulatory compliance to ensure marketed product quality.
- Responsibility for site regulatory inspections.
- Coordinate development of area training plans in order to manage the training, qualifications and educational needs of the Quality Operations colleagues.
- Manage talent development to assure adequate current capabilities and future succession for critical positions.
- Develop and maintain an organizational structure consistent with the area needs and goals, including the preparation and administration of annual performance assessments and discussions.
- Optimize site effectiveness and efficiency to ensure site performance goals are achieved or exceeded without compromising quality and compliance.
- Provide strategic leadership to QO and to the site on quality.
- Minimum of 10 years related pharmaceutical experience and 5 years quality operations experience with minimum of B.S., preferably M.S. in a Science related fields such as degree in Chemistry, Microbiology, Pharmacy or Chemical Engineering.
- Master's degree preferred; or equivalent combination of work experience and education.
- At least 5 years of demonstrated success leading and developing professional colleagues and developing a staffing / organizational structure in a QO or manufacturing environment.
- It is desirable to have a demonstrated success as a Site QO Leader and an agent of change. Related experience in at least 1 or 2 different pharmaceutical manufacturing facilities preferable.