Senior Manager, Clinical Quality Assurance
$170k - $185k USD
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 Clinical Quality team strives to ensure that the clinical quality management system (QMS) is optimized to foster a culture where quality innovation matches the company’s goals. The Senior Manager, Clinical QA is responsible for providing strategic input to GCP-related compliance activities, managing audits of service providers and providing QA oversight of Ocular Therapeutix sponsored trials. This position will implement and optimize the risk-based quality strategy in coordination with the functional areas and Quality team employing a solution-oriented approach to quality management, quality partnership, quality improvement, and quality excellence.
Principal Duties and Responsibilities include the following:
• Plan and conduct audits of suppliers, investigator sites, and internal processes to assess compliance with the applicable regulatory requirements, guidelines, standards, agreements and / or Standard Operating Procedures.
• Write and distribute audit reports
• Collaborate with cross-functional teams to ensure timely resolution of audit findings and follow up on corrective and preventive actions (CAPAs).
• Manage audit scheduling, reporting, and tracking of audit activities, including audits outsourced to third parties
• Evaluate the design, feasibility, and operational integrity of clinical trial protocols
• Identify gaps or weaknesses in protocol implementation that could impact trial participant safety, data reliability, or regulatory compliance.
• Ensure consistent implementation, use and review of SOPs.
• Escalate issues to management in a timely manner implementing appropriate solutions, including preventive actions.
• Collaborate with internal cross-functional teams to improve quality and increase efficiencies.
• Support Ocular Therapeutix Quality Management System (QMS) by assisting with the development and updating of standard operating procedures and other controlled documents.
• Lead functional process improvement initiatives to drive efficiencies and effectiveness of Clinical Quality Assurance processes.
• Provide guidance and training on GXP regulations, corporate standards, and quality policies
• Provide support for inspection readiness and inspections
• All other duties as needed or assigned.
Qualification Requirements:
• A minimum of a bachelor’s degree in Life Sciences or equivalent
• Experience may be substituted for education.
• 8+ years of experience in the pharmaceutical / biopharmaceutical / CRO industry (experience in GXP roles).
• Strong GCP auditing experience
• Strong understanding of ICH-GCP, FDA regulations and guidance, as well as international requirements and standards
• Excellent analytical, communication and problem-solving skills
• Ability to manage multiple simultaneous projects
• Well-organized, meticulous and thorough
• Commitment to diversity, equity, and inclusion
Working Conditions
• Remote based
• Willingness to travel up to 40% (including international travel)
Salary Range
$170,000—$185,000 USD
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.