Sr Manager, GMP QA
30 Enterprise Suite 400 Aliso Viejo, CA 92656
The Quality team supports Company throughout the product development and commercial life cycle by interacting with FDA and other regulatory authority agencies, facilitating regulatory activities, preparing Quality-related documentation, and coordinating company-wide interactions. This is accomplished by a thorough understanding and knowledge of cGMP (current Good Manufacturing Practice) regulations and requirements, in order to ensure Company, and its GMP suppliers, operates in compliance with these regulations.
The incumbent will be responsible for working closely with interdepartmental teams, planning and coordinating all quality-related activities, and providing input during the life cycle of Company’ s clinical and commercial products. He/she is responsible for assessing FDA and/or other regulatory authority regulations, and ensuring Company’ s compliance with these requirements.
- Provide quality oversight to ensure GMP suppliers execute appropriate quality systems during the processing and handling of Company’ s products.
- Review and approve GMP production batch records for the release of clinical and/or commercial products.
- Review and approve other GMP documents including, but not limited to, analytical and manufacturing validation protocols and reports, stability protocols and reports, and tech transfer protocols and reports.
- Provide oversight for processing laboratory change control requests, OOS notifications, and laboratory deviation and CAPA investigations.
- Responsible for handling product quality complaint investigations, deviations, CAPA’ s, and change controls within the TrackWise Management System.
- Manage the IP (investigational product) clinical oversight for IP manufacturing, release, distribution, and study monitoring for active clinical studies.
- Work with various departments and CMOs to plan, monitor, and schedule production times, establish clinical study timelines, and ensure IP inventory for national and international clinical studies.
- Provide oversight with respect to the proper administration and adherence of all policies and procedures to sustain a state of current Good Manufacturing Practices (cGMP) compliance at Company.
- Active participant in GMP audits, and inspection readiness activities, to ensure Company is in a constant state of inspection readiness.
- Interact with government agencies during GMP inspections.
- This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
- Bachelors or Masters degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field.
- At least 6 years experience in the pharmaceutical / biotechnology / medical device industry, with at least 3 years of Quality experience.
- Excellent understanding of cGMP regulations and related guidelines.
- Experience with aspects of product and analytical development.
- Experience in leading and working with multidepartmental functional teams.
- Must have excellent computer, written and verbal communication skills.
- Must be able to effectively collaborate with peers.
- Must be solutions oriented and pragmatic.