Ocular Therapeutix, Inc. · 1 day ago
Head of Quality Assurance
Bedford, MA
Full-time
Onsite
Director/Executive
$250K/yr - $270K/yr
15+ years expOcular Therapeutix, Inc. is a biopharmaceutical company focused on innovative therapies for eye diseases. The Head of Quality Assurance will oversee all aspects of QA, ensuring compliance with regulatory standards and leading a high-performing QA team.
BiotechnologyHealth CareMedical Device
Responsibilities
Lead the development and implementation of QA strategies, ensuring alignment of the Organization's goals and regulatory requirements
Set quality objectives and create strategic action plans to achieve desired quality results
Lead, mentor, and develop a high-performing QA team, fostering a culture of excellence, innovation, and continuous improvement
Collaborate with cross-functional leaders to integrate quality considerations into all aspects of product development, manufacturing, and commercialization
Establish/monitor Key Performance Indicators (KPIs) to measure and enhance the effectiveness of Ocular’s QMS and the performance of the QA Team
Oversee the development and implementation of quality policies, procedures, and training programs to ensure cGMP compliance and product quality
Provide guidance on quality risk management, change control, and CAPA (Corrective/Preventive Actions) processes
Participate in due diligence activities for potential partnerships, acquisitions, or expansion opportunities, assessing quality implications and integration challenges
Directly manage an excellent team of QA professionals and provide strategic leadership to the QA Team for sustained QMS programs with a continuous focus on improvement
Prepare employee development plans and provide regular performance reviews
Accountable for the creation and execution of comprehensive QA policies and programs
Accountable for ensuring all processes, testing protocols, and standards are rigorously followed to maintain product integrity
Participate in CCRB (Change Control Review Board) actions to review and approve all critical change control documents and approve verification and validation protocols and their corresponding final reports
Stay informed on industry standards and government regulations to ensure all company quality processes meet or exceed these requirements
Work closely with regulatory bodies to maintain compliance and support responses to Health Authorities as needed
Participate in the preparation, review and approval of CMC sections of regulatory filings
Incorporate QbD (Quality by Design) into development activities to ensure successful scale-up and commercialization capabilities
Provide guidance on quality investigations as needed for all development and commercial products
Accountable for the timely completion of CAPAs to ensure cGMP and GxP compliance
Accountable for the development and direct management of quality investigations of customer complaints, non-conforming materials and processes, CAPAs, and product quality related risk analysis
Accountable for the compliance of third-party suppliers with applicable government regulations
Ensure timely release of clinical and commercial product batches
Establish and direct audit and surveillance protocols to monitor the production process and initiate quality investigations as needed to ensure compliance
Accountable to enhance existing training programs, standards, tools, and methods to cultivate a culture of quality throughout Ocular
Ensure that all team members are adequately trained in applicable procedures
Oversee development of personnel within the Quality Organization
Drive continuous improvement initiatives across all quality processes
Utilize data and analytics to identify areas for enhancement and implement solutions
Serve as the primary point of contact for QA related inquiries
Provide timely and regular reports to Senior Management on product quality status, compliance issues, status of QA programs, quality improvement initiatives, and QMS operational status
Qualification
Required
Bachelor's Degree in Life Sciences or related field
15+ years of experience in the pharmaceutical industry with prior quality management experience
Experience working in a GxP setting (commercial and/or clinical)
Expertise in QMS and compliance
Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others
Knowledge of electronic systems
Experience with external regulatory inspections (e.g., FDA)
Excellent organizational skills and attention to detail
Strong interpersonal, verbal and written communication skills
Computer literacy, proficiency in MS Office, Excel, PowerPoint
Company
Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to redefining the retina experience across drug development, treatment, and outcomes.
51-200 employees
H1B Sponsorship
Ocular Therapeutix, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (1)
2023 (3)
2022 (4)
2021 (10)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.19BKey Investors
Ascension VenturesPolaris Partners
2025-09-30Post Ipo Equity· $475M
2024-02-22Post Ipo Equity· $325M
2023-12-13Post Ipo Equity· $115.11M
Leadership Team
Michael Goldstein
Chief Strategy Advisor
Steve Meyers
Chief Commercial Officer
Recent News
2025-12-09
2025-12-08
Company data provided by crunchbase