What are the responsibilities and job description for the Director, Quality Control position at Glaukos Corporation?
The Senior Manager, Quality Control role, based in San Clemente, CA will be responsible for leading testing for clinical supply and commercial products including internal and 3rd party laboratory management for receiving materials, In-process testing, Finished Product release testing, stability and complaint investigation.
The Senior Quality Control manager will implement strategy and promote effective operation of the quality control program for drugs and combination devices at Glaukos.
This person will work in close partnership with the Company's R&D, Applied Research and Regulatory Affairs groups, and will be the interface with the Quality groups at third party testing labs.
Responsibilities:
* Serve as Quality Control Subject Matter Expert for assigned drug programs.
* Ensure that method development, transfer, and validations meet current ICH and other regulatory guidelines.
* Perform quality control activities (such as analytical validation protocol/report review and approval, specification review and approval, laboratory record review and release, etc.) to ensure timely delivery of DS, DP and finished (packaged and labeled) to support the clinical and commercial products
* Write/approve stability trending reports, method transfer reports, OOS investigations, etc.
* Perform and/or participate in internal and external QC audits, as assigned.
* Participate on cross-functional teams, as needed.
* Provide input on improvements to existing processes relating to job roles and responsibilities as needed
* QC Lab Management in a GMP setting
Experience:
* 8 years industry experience in a QC leadership role
o Demonstrated ability to implement procedures which ensure compliance to GMP and regulatory standards.
o Working knowledge of technical and analytical aspects of pharmaceutical quality control.
o Working knowledge FDA/EMA/ICH guidelines and GMPs.
o Working knowledge of method transfer and validation as applied to pharmaceutical testing and equipment.
o Working knowledge of preparation and submission activities, specifically in relation to CMC, for regulatory filings in USA, EU and Rest of World.
o Demonstrated leadership experience and skills, with the ability to coordinate multiple projects in a demanding, fast-paced environment.
o Excellent oral and written communication skills for effectively interfacing with other departments within the company, suppliers, and other contractors.
o Ability to represent QC department at regulatory inspections and audit external contract labs for compliance
o Ability to handle complex and challenging situations with minimal direction.
Education:
* Bachelor's degree, Masters or PhD in Analytical Chemistry or Microbiology preferred.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
