Sr. Manager Quality Assurance

The Tsui Group is seeking a candidate with proven experience in working on complex, multi‐phase, multi‐million dollar design and construction projects to provide as-needed, lessons learned facilitation and support services. The candidate must be flexible and able to assist the Program Management Office in the daily tasks of managing the Lessons Learned Program. Assignments to include Lessons Learned workshop preparation, facilitation, and Lessons Learned Registers for database. The Lessons Learned database will provide potential risk areas to focus attention and resources. They key is to focus the discussion of the item on what occurred and the discussion of the area of improvement on how this item could have been mitigated. 

The candidate must also be able to demonstrate a professional demeanor, and have a clear understanding of project cost, schedule, documentation, and risk assessment principles, and able to multi‐task and work in a fast‐paced work environment. ...

• Conduct non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups.
• Trains and supervises document review personnel; batch release personnel, Maintains accurate record of approved, quarantined, rejected products.
• Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, ISO 13485:2003).
• Review and release final product and maintain authorized person (AP) status; also reviews release and compliance of bulk and intermediates where applicable.
• Conduct audits and inspections; also prepare draft responses to audits and inspections
• Oversee/coordinate drug stability program.
• Oversee process validation lifecycle program.
• Oversee document control program.
• Maintains working knowledge of QA inspection requirements for components, raw materials, in-process/bulk and finished goods.
• Ensures that review of...

Join us as the Senior Manager/Associate Director of Quality Assurance at Frontier, where precision meets purpose. In this pivotal role, you'll oversee GCP/GLP Quality Assurance activities, ensuring meticulous adherence to standards that drive our growth objectives forward. Beyond external engagements, you'll be a key collaborator, bridging departments to fortify our operational integrity. Your focus on developing our QA infrastructure will be instrumental in realizing our strategic initiatives. If you're ready to bring your analytical prowess to the table, join us and report directly to the head of RA/QA as we navigate the complexities of quality assurance with precision and purpose.

Requirements

What will you be doing?

• Development, implementation, maintenance of quality assurance infrastructure & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the...