Job Description
How will you make an impact?
The Senior Quality CMO Specialist will provide quality support for Glaukos Drug product manufacturing (primary or secondary or distribution) at External Contract Manufacturing Organizations (CMOs). The Sr. Specialist will contribute and support the completion of milestones associated with specific projects and support ongoing quality assurance responsibilities in support of Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA's as well as Batch release activities. Additionally, the individual may manage data tracking systems to maintain metrics and trends.
The individual will work closely with internal cross-functional impacted areas, such as Supply Chain Operations and logistics, Internal Quality Assurance and CMC as well as external Vendors. Under the guidance of the Manager of Quality Assurance this individual will be the point person from the quality organization for supporting all commercial and clinical supply chain external quality operations and activities associated to finished goods manufacturing through final finished goods distribution.
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What will you do?
The Senior Quality CMO Specialist will perform all responsibilities in accordance with company policies, procedures, and regulations.
Additional responsibilities will include:
- Review, approve and disposition from drug substance to finished goods and labeling batch records.
- Provide quality oversight/support to CMO and distribution vendors.
- Review, investigate and report temperature excursions and manage product impact assessment based on data.
- Assist in developing and updating procedures to support commercial/clinical supply chain and distribution operations.
- Track batch release metrics as well as vendor-based deviations.
- Manage Quality Systems including change controls, deviations and complaints within Glaukos systems as well as tracking those at CMOs.
- Review and assess deviations, including risk assessments, participate in root cause analysis investigations, tracking and follow ups.
- Review client specific standard operating procedures and controlled documents issued by the CMOs.
- Provide QA support for technology transfer and improvement of existing manufacturing processes.
- Develop and maintain metrics for key quality performance indicators for cross-functional visibility.
- Manage Supply Chain Quality deliverable timelines and provide updates to internal and external customers on a regular basis.
- Support contract manufacturing sites and perform Person-in-Plant duties including validation activities, protocol approvals, and all other associated quality functions.
- Partner with External Manufacturing Operation to execute technical transfer deliverables.
- Develop and Maintain Quality Technical Agreements and annual product summaries.
- Ability to prioritize and work independently with minimal supervision and an ability to escalate issues as needed.
- Bachelor's degree required; Master's preferred.
- 5-8 years of experience in pharmaceutical quality, GMP QA/QC/compliance, or laboratory settings.
- Strong knowledge of Quality Systems, GMPs, ICH guidelines, and industry regulations (21CFR 210/211, 820, ISO 13485).
- Proven analytical and quality background in the pharmaceutical industry.
- Experienced in product release, NCMRs, product complaints, deviations, and batch record reviews for initial manufacturing campaigns.
- Previous experience with clinical, commercial, and multiproduct facilities, including CMO operations.
- Understanding of analytical method qualification/validation and stability requirements per ICH.
- Excellent documentation skills, detail-oriented, with strong interpersonal and communication abilities.
- Ability to work well in a team.
- Willingness to travel domestically (~15%).
About Us
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.
Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.
Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.
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 in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.
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.