Sr. Director, Quality Assurance

<strong>At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases&mdash;therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.<br /><br />Help put the next wave of disruptive technologies on the market. Work with a team that&rsquo;s dedicated to making a difference in the lives of patients worldwide.<br /></strong>

Burlington, MA

Glaukos

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. <br /><br />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&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.<br /><br />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. https://www.glaukos.com/

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Full time

Overview: The Senior Director, Quality Assurance based in Burlington, MA will be responsible for managing all Quality Systems activities at Glaukos Corporation Boston for both pharmaceutical and medical device products. He/she is designated Quality Management Representative responsible for establishing and maintaining the quality system elements. Ensures Glaukos products and procedures are compliant with all applicable worldwide product registration and quality system requirements. Leads quality activities in the Design Control process, ensuring that design control activities are thoroughly completed and meet the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 11, 210, and 211. Responsible for oversight of Supplier Quality Management related to suppliers and contract manufacturing for commercial and development to assure adherence to GXP and relevant US and EU regulations. &nbsp;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.
Responsibilities: <ul> <li>The appointed Quality Management Representative responsible for: ensuring that Glaukos Quality System requirements are effectively established and maintained in accordance with quality system regulations and reporting on the performance of the quality system. Activities include project planning, risk management, validation planning, and review of all design changes. As auditor host, plans for and participates in quality system audits and inspection related matters by governmental authorities, interfacing directly with FDA and state and/or notified body personnel. Oversees all elements required for the Glaukos Quality System to obtain and maintain ISO facility certification and prepare for FDA facility inspections. Organizes and leads periodic Management Review meetings. Monitors the complaint process (intake, investigation, root cause analysis, closure, and trending). Advises on areas of compliance risk and recommends appropriate corrective and preventive actions. Responsible for ensuring all employees are trained on quality system requirements.</li> <li>Responsible for documentation control activities, including the review and approval of critical Glaukos documents (SOPs, drawings, forms, etc.). Specific activities include maintaining DHR, DMR, DHF and technical files to ensure current and correct information. Responsible for the generation and review of new SOPs and revisions to existing documentation to comply with all aspects of the quality system regulation and ISO requirements. Responsible for monitoring the Quality Systems and their effectiveness, assessing risk, and escalating any product or compliance concerns.</li> <li>Responsible for oversight of Supplier Quality Management related to suppliers and contract manufacturing for commercial and development to assure adherence to GXP and relevant US and EU regulations. &nbsp;&nbsp;Ensures compliance with GMP, GLP, GCP and relevant ICH, US and EU regulations. This role encompasses all aspects of Quality, from strategic planning to hands-on implementation.</li> <li>Ensures Glaukos products and procedures are compliant with all applicable worldwide product registration and quality system requirements</li> <li>Promotes within the organization the understanding of the Quality System Regulations and the benefits of achieving high standards of compliance. Hands-on leader who is results-oriented and able to roll up their sleeves in an entrepreneurial environment. Provides leadership and direction to domestic and international staff and champions the Quality culture within the organization. Using metrics to identify trends and areas for improvement drives the development, deployment, and sustainability of quality management systems for the design, manufacture, and supply of product. Interacts with direct sales and distributors to understand and respond to customer concerns, preferences, and complaints.</li> <li>Reviews and approves, as needed, any site validation master plans, protocols, and reports for equipment, facilities and finished products. Participates in the review and approval of design development milestone releases.</li> <li>Ensures Calibration and Maintenance programs are in place and effective. Responsible for&nbsp;ensuring adequate environmental and production monitoring/process control. Participates in risk management discussions (PHA, FMEA, etc.).</li> </ul>
Requirements: <ul> <li>Bachelor&rsquo;s Degree in a scientific discipline and 10 years industry experience.</li> <li>At least 10 years progressive work experience in the area of Quality within the medical device and/or pharmaceutical industry.</li> <li>Current, in-depth knowledge of FDA, European Union and other international regulatory, quality and clinical requirements pertaining to medical devices and pharmaceuticals used in ophthalmic surgery.</li> <li>Demonstrated ability in leading/championing the Quality function in an entrepreneurial organization</li> <li>Experience with internal and vendor auditing. Experience with facility and product validations.</li> <li>Excellent analytical skills (interpret data, summarize data, present data).</li> <li>Excellent written and verbal communication skills.</li> <li>Motivated and able to work independently, as well as within a team. Exhibits personal integrity, credibility, and responsibility.</li> <li>Excellent organizational skills and ability to work on multiple projects/tasks.</li> <li>Meets milestones and schedules.</li> </ul>