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.

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

Benefits

Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GCP auditingclinical trial protocolsaudit reportingcorrective and preventive actionsquality management systemstandard operating proceduresprocess improvementregulatory compliancedata reliabilityinspection readiness

Soft Skills

analytical skillscommunication skillsproblem-solving skillsorganizational skillsattention to detailcollaborationtime managementcommitment to diversityequityinclusion