Director, Quality Assurance
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 Director, Quality Assurance has the functional responsibility for quality control, quality assurance, and quality systems of pharmaceutical development and oversight and reporting on global corporate Glaukos compliance. This position requires a broad range of QA experience in GMP, GLP, and GCP and working with internal collaborators and external vendors. This role also collaborates with internal functions (e.g. R&D, Operations, Legal, HR, Finance, IT) to execute the activities and ensure alignment with Glaukos procedures.
- Responsible for managing all QA/QC activities pertaining to pharmaceutical product development at Glaukos Corporation.
- Ensures Glaukos products and procedures are in compliance with all applicable worldwide product registration and quality system requirements.
- Leads quality activities pertaining to GMP, GLP, and GCP and relevant ICH, US and EU regulations. This role encompasses all aspects of Quality, from strategic planning to hands-on implementation.
- Interacts with sales personnel and distributors to understand and respond to customer concerns, preferences, and complaints.
- Assures active quality leadership in critical processes including audits, design reviews, design transfers, and customer feedback.
- Acts as the primary contact with governmental and certifying agencies for audits and inspections related matters. Provides leadership and direction, and champions the Quality culture within the organization.
- 12+ years of progressive managerial experience within the Quality function of a pharmaceutical company. Experience leading a Quality function is required.
- Worked on the full product development lifecycle
- Extensive knowledge and experience in GXP and QA principles, practices & industry standards
- A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations & business needs
- Experience with using risk-based principles & decision making to ensure compliance at all stages of development
- Proven track-record of leadership & building relationships with both internal & external customers Strong negotiation skills, flexibility & ability to provide a solution-based approach to emerging challenges
- BS in Chemistry, Pharmacy, Biology or a related pharmaceutical science.
- MS or PhD in Chemistry is preferred
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
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.