Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
Position Summary:
Responsible for maintaining quality standards for Ocular’s pharmaceutical and medical device products by managing activities associated with Risk Management, Supplier Quality Management, Document Control, Training, Internal Auditing, and Inspection Readiness. This is a critical position, and onsite presence is essential due to the level of cross-functional collaboration that it involves. The right candidate will have familiarity with and experience in all of the responsibilities listed below but may focus on a subset of them for their core work depending on the background and experience of the candidate. This position is reporting to the Head of Global Quality Compliance.
Principal Duties and Responsibilities include the following:
- Manage and maintain the following areas to drive improvements and achieve adherence with regulatory expectations: Risk Management, Supplier Quality Management, Audits, Documentation, Training, Inspection Readiness, and Quality Compliance.
-
Inspection Readiness: Prepare the site for the success of internal and external audits ensuring that all the processes and systems remain aligned and in compliance with the applicable regulatory guidelines and industry standards. Execute internal audits as necessary.
-
Supplier Qualification: Manage the qualification of vendors supporting Ocular’s GxP operations, including coordinating and executing supplier qualification audits. Collaborate in cross-functional scenarios for the onboarding of suppliers, resolution of SCARs (Supplier Corrective Action Requests) and assessment of SCNs (Supplier Change Notifications).
-
Risk Management: Identify, assess, and mitigate risks related to Ocular drug development, manufacturing, safety, regulatory compliance, and market access, focusing on ICH Q9 and using tools like FMEA to ensure patient safety, regulatory adherence, and business continuity.
-
Training: Manage logistics for mandatory training (GMP, SOPs, skills) using Ocular’s LMS, ensuring regulatory compliance by scheduling sessions, tracking records, generating reports, supporting audits, and coordinating with Quality/Dept heads to align training with production needs and quality standards.
- Manage deviations, change controls, and CAPAs associated with the programs under responsibility, as
- Review departmental documentation (e.g., Standard Operating Procedures, Work Instructions, etc.) for gaps and improvements, and revise as necessary.
- Identify opportunities for improvement and implement necessary actions to optimize the processes/systems and add efficiency to the Quality operations.
- Participate in the implementation of new electronic systems, such as MasterControl, as necessary.
- Adhere to all the policies and procedures as well as to the GxP guidelines driving the operations at OTX.
- Accomplish the objectives and goals of the Quality Organization.
- Perform additional duties as deemed appropriate.
Qualification Requirements:
- Bachelor’s
- 10+ years of experience in the pharmaceutical industry.
- Experience working in a GxP setting (commercial and clinical).
- Expertise in Risk Management, Inspection Readiness, Supplier Management, Training, and general Quality Compliance.
- Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others.
- Knowledge of electronic systems, such as MasterControl.
- Experience with external regulatory inspections (e.g., FDA).
- Excellent organizational skills and attention to
- Strong interpersonal, verbal and written communication
- Computer literacy, proficiency in MS Office, Excel, PowerPoint,
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.
