Quality Assurance (GMP), Manager
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.
The Quality Assurance Manager, based in San Clemente, California will implement strategy and promote effective operation of the quality assurance program for combination devices at Glaukos. The Quality Assurance Manager will ideally have CMC, preferably with experience with drug/device combination products. They 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 the CMOs, as it relates to all quality assurance matters.
Drug Combination Device Quality Management:
- Serve as GMP Quality Subject Matter Expert for assigned drug programs.
- Follow established procedures for the oversight of quality aspects of pharmaceutical development in an outsourcing environment, for drug substance (DS), drug product (DP) and clinical trial material (CTM), including the quality aspects of process and formulation development, manufacturing, analytical testing, packaging, labeling product release, and associated stability programs for assigned drug programs.
- Oversee quality aspects of pharmaceutical development in an outsourcing environment, for DS, DP and CTM, including the quality aspects of process and formulation development, manufacturing, analytical testing, packaging, labeling, product release, distribution and associated stability programs, for assigned drug programs.
- �Perform quality assurance activities (such as validation protocol/report review and approval, specification review and approval, batch record review and release, etc.) to ensure timely delivery of DS, DP and finished (packaged and labeled) product to support the clinical development plan, as well as the commercial sales plan as appropriate.
- �Follow established quality systems procedures required for appropriate GMP compliance including change control, deviations, complaints, training, etc.
- �Ensure supporting product, supplier and quality systems documentation is maintained in accordance with company and industry standards.
- �Provide Quality Control of documents in support of regulatory submissions for investigational products, market applications and periodic updates.
- �Perform and/or participate in internal audits, as assigned.
- �Participate on cross-functional teams, as needed.
- Report to supervisor on project progress, issues and problem solving.
- �Provide input on improvements to existing processes relating to job roles and responsibilities as needed.
- �Follow established procedures for the oversight of supplier quality management activities associated with combination products.
- �Oversee supplier quality management activities for assigned suppliers. Oversight to include confirmation of compliance, management of quality audits and inspection readiness activities, and appropriate resolution of corrective and preventive action plans, as required.
- �Apply company and industry standards for quality assurance and compliance to regulatory requirements to assigned drug programs and suppliers.
- �Assist with computer validation activities, as assigned.
- Participate in special projects as needed.
- Support other objectives, as assigned.
- �Provide back-up support to other members of the Quality Assurance department as appropriate and as needed.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation.
Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
Meet Some of Glaukos Corporation's Employees
R&D Project Engineer
Kristine oversees the iterative design process at Glaukos, making sure that new products meet regulatory and quality assurance standards, implementing improvements to existing product lines.
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