Manager, Quality Assurance Compliance
TLDR
Manage regulatory compliance in quality assurance while driving improvements in vendor management and audit readiness in a biopharmaceutical setting.
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.
Principal Duties and Responsibilities include the following:
- Manage and maintain the following areas to drive improvements and achieve adherence with regulatory expectations: Supplier Quality Management, Audits, Documentation, Training, Inspection Readiness, and Quality Compliance.
- 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.
- Coordinate vendor audits and manage the qualification of vendors supporting Ocular’s GxP operations, including vendor selection and corresponding risk evaluation.
- Collaborate in cross-functional scenarios for the onboarding of vendors, resolution of SCARs (Supplier Corrective Action Requests) and assessment of SCNs (Supplier Change Notifications).
- Accomplish the objectives and goals of the Quality Organization. Manage deviations, change controls, and CAPAs associated with the programs.
- Review departmental documentation (e.g., Standard Operating Procedures, Work Instructions, etc.) for gaps and improvements.
- Adhere to all the policies and procedures as well as to the GxP guidelines driving the operations at OTX. 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.
Qualification Requirements:
- Bachelor’s degree in Pharmaceutical Science, Biomedical Science or a related field and six years regulatory experience in the pharmaceutical industry.
- Experience must include six years each of the following: working in a GxP commercial and clinical setting; vendor management, Quality Management System, and compliance; and domestic and international regulatory guidelines such as CFR 210, 211, USP, FDA, ICH, MHRA, or EMA.
- Experience must include three years each of the following: electronic systems, such as MasterControl; and external regulatory inspections (e.g., FDA).
- Experience may be gained concurrently.
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.
Ocular Therapeutix develops and commercializes innovative therapies for eye diseases through its proprietary bioresorbable hydrogel technology, ELUTYX™. Catering primarily to ophthalmic needs, the company aims to simplify treatment protocols and enhance patient care by offering advanced drug delivery solutions.