Senior Manager, Clinical Quality Assurance
About The Position
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.
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
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
