Description
JOB DESCRIPTION How will you make an impact?The
Director, Quality Assurance Pharmaceutical Development will be based out of either San Clemente or Aliso Viejo, CA to support for early phase pharmaceutical development programs at Glaukos Corporation. Is responsible for the development and implementation of phase appropriate GMP to support pharmaceutical product development from pre-clinical, through clinical and into commercial readiness.Ensures Glaukos products and procedures are in compliance with all applicable worldwide product registration and quality system requirements. Participates with project teams to ensure manufacturing transfer activities are thoroughly completed in order to meet the requirements of 21 CFR 210/211, EudraLex Volume 4, and ICH Q8/Q10.
What will you do?- Responsible for providing QA support to product development teams to ensure GMP compliance is maintained and is appropriate for the phase of development the product is in and to ensure Quality decisions are properly documented communicated across the various functional teams.
- Responsible engaging with internal and external customers to ensure the necessary quality systems are adhered to during product development activities.
- Represent Quality on project core and sub teams to ensure compliance is being maintained to an appropriate level for the phase of development of a given project.
- Capable of evaluating complex compliance and manufacturing situations and providing guidance on the available pathways which maintain compliance.
- Assist with the development and implementation of a pharmaceutical development program that provides the flexibility for early phase development but ensures the necessary development history is documented and utilized to implement appropriate process controls and product quality attributes.
- Provide support for development and qualification protocols, and reports for equipment, facilities, and pre-clinical and clinical stage products.
- Participates in the review and approval of design development milestone releases.
- Provide QA oversight and production support for the manufacture of pre-clinical and clinical stage products.
- Promotes within the organization and throughout the development project teams the understanding of the Quality System Regulations and the benefits of achieving high standards of compliance.
How will you get there?- Bachelor's Degree in a scientific discipline, preferably chemistry or microbiology.
- At least 7-10 years progressive work experience in the area of Quality within the Pharmaceutical industry.
- At least 4 years supporting early phase pharmaceutical product development
- Current, in-depth knowledge of FDA, European Union and other international regulatory, quality, and clinical requirements pertaining to pharmaceuticals, experience with ophthalmic products preferred.
- Experience working in a fast-paced pharmaceutical development environment.
- Experience with supplier management and vendor auditing, desired.
***Please note, Glaukos compensation ranges were not directly given to LinkedIn and are estimated ranges from similar roles. Glaukos provides competitive industry and functional compensation. Please apply and inquire with your recruiter. ***U.S. employees of Glaukos Corp. and its subsidiaries (a "Company"), who begin employment after January 1, 2022 must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regard to an individual's disability or religion or on any other basis prohibited by applicable law.
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous paid time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class!Glaukos has been named one of the Top Workplaces by the Orange County Register for the past 3 years!
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.
ABOUT US Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device-the iStent®-in the United States, followed by our next-generation iStent inject® device in September 2018 and iStent inject® W in September 2020.
In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex including sexual orientation and genderidentity, national origin, disability, protected Veteran Status, or any othercharacteristic protected by applicable federal, state, or local law.
