Head of Quality Assurance

Ocular Therapeutix•Bedford, MA

1d•$250,000 - $270,000•Onsite

About The Position

The Head of Quality Assurance is accountable for overseeing all aspects of Quality Assurance within Ocular Therapeutix. This role involves the planning, development, and execution of QA policies, programs, and initiatives to ensure that all materials, parts, and products meet established quality standards. This role is also accountable for company compliance with all cGMP, GxP, and ICH governmental regulations. The Head of QA will set quality objectives, formulate strategic action plans, and establish audit and surveillance protocols and be accountable for overseeing the Quality Management System (QMS) and monitoring the entire production process to ensure compliance with the applicable regulatory requirements. The Head of QA will provide leadership and guidance to personnel within QA groups and serve to support and liaise with other Functional Areas. This is a critical position within the Quality Leadership Team (QLT) and onsite presence is essential due to the level of cross-functional collaboration that it involves. This position is reporting to the VP, Global Head QA/QC.

Requirements

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
Strong interpersonal, verbal and written communication
Computer literacy, proficiency in MS Office, Excel, PowerPoint

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.