Ocular Therapeutix
Executive Director, Quality Assurance
Ocular Therapeutix, Bedford, Massachusetts, us, 01730
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.
EXECUTIVE DIRECTOR, QUALITY ASSURANCE
The Executive Director of Quality Assurance is accountable for overseeing all aspects of Quality assurance within the organization. This role involves the planning, development, and execution of quality assurance policies, programs, and initiatives to ensure that all materials, parts, and products meet established quality standards and accountable for company compliance with all CGMP, GxP and ICH governmental regulations. The Executive Director will set quality objectives, formulate strategic action plans, and establish audit and surveillance protocols and be accountable for overseeing the quality management system and monitoring the entire production process to ensure regulatory compliance with the applicable governmental regulations. The Executive Director will provide leadership and guidance to personnel within quality assurance groups and serve to support and liaise with other departments.
KEY RESPONSIBILITIES
Leadership & Strategy: Lead the development and implementation of quality assurance strategies, ensuring alignment of the organization's goals and regulatory requirements. Set quality objectives and create strategic action plans to achieve desired quality results.
Provide visionary leadership and strategic direction to a team of approximately 8 full-time quality professionals (anticipating adding additional staff in near future). This key executive will be responsible for shaping the quality culture across the organization, ensuring compliance with regulatory standards, and driving continuous improvement in quality systems and processes.Develop and execute a comprehensive quality strategy aligned with the company's business objectives and regulatory requirements for ophthalmic combination drug productsLead, mentor, and develop a high-performing quality team, fostering a culture of excellence, innovation, and continuous improvementCollaborate with cross-functional leadership to integrate quality considerations into all aspects of product development, manufacturing, and commercializationServe as the primary liaison with regulatory agencies on quality matters, representing the company in inspections and auditsEstablish key performance indicators (KPIs) to measure and enhance the effectiveness of quality systems and team performanceOversee the development and implementation of quality policies, procedures, and training programs to ensure GMP compliance and product qualityProvide executive-level guidance on quality risk management, change control, and CAPA processesManage the quality assurance/control department budget, resource allocation, and strategic hiring decisionsParticipate in due diligence activities for potential partnerships, acquisitions, or expansion opportunities, assessing quality implications and integration challenges
Directly manage quality assurance staff and provide strategic leadership to the quality assurance group for sustained quality system programs with a continuous focus on improvement.Quality Assurance Programs: Accountable for the creation and execution of global comprehensive quality assurance policies and programs. Accountable for ensuring all processes, testing protocols, and standards are rigorously followed to maintain product integrity. Enable a quality assurance process for product release in the EU working in conjunction with the Qualified Person. Participate in change control review board actions to review and approve all critical change control documents and approve verification and validation protocols with final reports.Regulatory Compliance: Stay informed on industry standards and governmental 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 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.Audit & Surveillance: Lead quality investigations as needed for all development and commercial products. Accountable for the timely completion of corrective and preventative actions to ensure CGMP and GxP compliance. Accountable for the development and direct management of quality investigations of customer complaints, non-conforming materials and processes, corrective and preventive actions, and product quality related risk analysis. Accountable for the compliance of third-party suppliers with applicable government regulations. Lead all internal and external quality audits. 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.Training & Development: Develop and implement training programs, standards, tools, and methods to cultivate a culture of quality throughout the organization. Ensure that all team members are adequately trained in quality control procedures. Oversee development of personnel within the quality department; direct training programs and prepare employee development plans and provide regular performance reviews.Continuous Improvement: Drive continuous improvement initiatives across all quality processes. Utilize data and analytics to identify areas for enhancement and implement solutions. Ensure annual product reviews are completed timely.Reporting & Communication: Serve as the primary point of contact for quality-related inquiries. Provide timely and regular reports to senior management on product quality status, compliance issues, status of quality assurance programs, quality improvement initiatives, and quality management system operational status.Manage Quality Assurance TeamKEY REQUIREMENTS
Minimum 15 years' experience in a Quality function with increasing levels of responsibility in the biotech/pharmaceutical industryA minimum of 5 years in a senior manager or leadership capacityDirect experience with CGMP, GxP quality assuranceExcellent communication skills, both written and verbalDemonstrated ability to work effectively in a team-oriented environment.Travel may be required.EDUCATION
Bachelor's degree in scientific discipline or related field required; Advance-degree-equivalent experience in production and quality management is desired.
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/.
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.
EXECUTIVE DIRECTOR, QUALITY ASSURANCE
The Executive Director of Quality Assurance is accountable for overseeing all aspects of Quality assurance within the organization. This role involves the planning, development, and execution of quality assurance policies, programs, and initiatives to ensure that all materials, parts, and products meet established quality standards and accountable for company compliance with all CGMP, GxP and ICH governmental regulations. The Executive Director will set quality objectives, formulate strategic action plans, and establish audit and surveillance protocols and be accountable for overseeing the quality management system and monitoring the entire production process to ensure regulatory compliance with the applicable governmental regulations. The Executive Director will provide leadership and guidance to personnel within quality assurance groups and serve to support and liaise with other departments.
KEY RESPONSIBILITIES
Leadership & Strategy: Lead the development and implementation of quality assurance strategies, ensuring alignment of the organization's goals and regulatory requirements. Set quality objectives and create strategic action plans to achieve desired quality results.
Provide visionary leadership and strategic direction to a team of approximately 8 full-time quality professionals (anticipating adding additional staff in near future). This key executive will be responsible for shaping the quality culture across the organization, ensuring compliance with regulatory standards, and driving continuous improvement in quality systems and processes.Develop and execute a comprehensive quality strategy aligned with the company's business objectives and regulatory requirements for ophthalmic combination drug productsLead, mentor, and develop a high-performing quality team, fostering a culture of excellence, innovation, and continuous improvementCollaborate with cross-functional leadership to integrate quality considerations into all aspects of product development, manufacturing, and commercializationServe as the primary liaison with regulatory agencies on quality matters, representing the company in inspections and auditsEstablish key performance indicators (KPIs) to measure and enhance the effectiveness of quality systems and team performanceOversee the development and implementation of quality policies, procedures, and training programs to ensure GMP compliance and product qualityProvide executive-level guidance on quality risk management, change control, and CAPA processesManage the quality assurance/control department budget, resource allocation, and strategic hiring decisionsParticipate in due diligence activities for potential partnerships, acquisitions, or expansion opportunities, assessing quality implications and integration challenges
Directly manage quality assurance staff and provide strategic leadership to the quality assurance group for sustained quality system programs with a continuous focus on improvement.Quality Assurance Programs: Accountable for the creation and execution of global comprehensive quality assurance policies and programs. Accountable for ensuring all processes, testing protocols, and standards are rigorously followed to maintain product integrity. Enable a quality assurance process for product release in the EU working in conjunction with the Qualified Person. Participate in change control review board actions to review and approve all critical change control documents and approve verification and validation protocols with final reports.Regulatory Compliance: Stay informed on industry standards and governmental 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 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.Audit & Surveillance: Lead quality investigations as needed for all development and commercial products. Accountable for the timely completion of corrective and preventative actions to ensure CGMP and GxP compliance. Accountable for the development and direct management of quality investigations of customer complaints, non-conforming materials and processes, corrective and preventive actions, and product quality related risk analysis. Accountable for the compliance of third-party suppliers with applicable government regulations. Lead all internal and external quality audits. 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.Training & Development: Develop and implement training programs, standards, tools, and methods to cultivate a culture of quality throughout the organization. Ensure that all team members are adequately trained in quality control procedures. Oversee development of personnel within the quality department; direct training programs and prepare employee development plans and provide regular performance reviews.Continuous Improvement: Drive continuous improvement initiatives across all quality processes. Utilize data and analytics to identify areas for enhancement and implement solutions. Ensure annual product reviews are completed timely.Reporting & Communication: Serve as the primary point of contact for quality-related inquiries. Provide timely and regular reports to senior management on product quality status, compliance issues, status of quality assurance programs, quality improvement initiatives, and quality management system operational status.Manage Quality Assurance TeamKEY REQUIREMENTS
Minimum 15 years' experience in a Quality function with increasing levels of responsibility in the biotech/pharmaceutical industryA minimum of 5 years in a senior manager or leadership capacityDirect experience with CGMP, GxP quality assuranceExcellent communication skills, both written and verbalDemonstrated ability to work effectively in a team-oriented environment.Travel may be required.EDUCATION
Bachelor's degree in scientific discipline or related field required; Advance-degree-equivalent experience in production and quality management is desired.
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/.