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:
The Quality Risk Management (QRM) Manager is responsible for driving the strategy, implementation, and maintenance of the QRM program within Ocular Therapeutix. This role ensures that quality risk assessment, mitigation, and control strategies are robust, compliant with ICH Q9(R1) guidelines, and integrated into the Quality Management System (QMS). The QRM Manager facilitates risk assessments, maintains the risk register, and fosters a proactive, risk-based culture to ensure patient safety and product quality throughout the product lifecycle in compliance with Quality Risk Management regulations and standards.
This is a critical position reporting to the Head of Global Quality Compliance. This role will require an onsite presence due to the level of cross-functional collaboration involved, although hybrid opportunities will be available.
Principal Duties and Responsibilities include the following:
-
QRM Program Leadership: Lead the development and execution of the site/corporate QRM program, ensuring alignment with global policies, procedures, and regulatory standards (FDA/EMA/ICH).
-
Risk Assessment Facilitation:Facilitate formal risk assessments (e.g., FMEA, HAZOP, PHA) with cross-functional teams (Manufacturing, R&D, Supply Chain) to identify and mitigate risks to product quality, safety, and compliance.
-
Risk Register & Monitoring:Maintain the corporate/site risk register and oversee the tracking of risk mitigation actions to closure.
-
Regulatory Inspection Support:Act as the Subject Matter Expert (SME) for QRM during internal audits, third-party audits, and Health Authority inspections.
-
Quality System Integration:Embed QRM principles into Quality Systems, including Change Control, Deviations, CAPA, and Material Qualification.
-
Training & Capability Building:Develop and deliver QRM training to cross-functional stakeholders to enhance risk awareness and the consistent application of QRM tools.
-
Metrics & Reporting: Define, monitor, and report on key quality risk metrics (KPIs) to leadership, identifying trends to drive continuous improvement.
Additional Responsibilities:
- 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.
- Adhere to all the policies and procedures as well as to the GxP guidelines driving the operations at Ocular Therapeutix.
- Accomplish the objectives and goals of the Quality Organization as appropriate.
- Perform additional duties as deemed appropriate.
Qualification Requirements:
- Experience: 6+ years of experience in the pharmaceutical or biotechnology industry, with at least 2–4 years specifically focusing on Quality Assurance, Quality Systems, or Quality Risk Management.
- Technical Knowledge: Deep knowledge of GxP regulations (cGMP, GCP, GLP), ICH Q9(R1), and ISO standards.
- Tool Proficiency: Proven experience with QRM tools and methodologies (e.g., FMEA, Fault Tree Analysis, HACCP).
- Strong leadership and influencing skills to work in a matrixed organization without direct authority.
- Excellent communication and facilitation skills for leading cross-functional teams.
- Ability to manage ambiguity and prioritize multiple projects under tight deadlines.
- Bachelor’s
- 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,
Working Conditions:
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.
