Director Quality Operations

The Director, Quality Operations will report to the Sr. Director Global Quality Assurance and be responsible for global GMP quality within our internal and external manufacturing operations for development and commercial programs. This position will lead the Quality Operations and Quality Engineering teams who provide daily operational quality support.

This is an in-person role based at our Northbridge facility. We offer a hybrid work schedule. The expectation will be at least three days in the office but could be more at times as we approach upcoming critical milestones. Travel to our Watertown location is also required to support a multi-site team one to two times per week. May be more as business needs necessitates.

May travel to external partner locations (5-10%).

• Management of internal and external quality operations in support of GMP manufacturing (clinical and commercial) activities
• Plan, organize, and direct all QA Operations activities related to incoming material release, batch record review, QC testing, lot disposition, Quality Event Management, Annual Product Report reconciliation, and quality oversight of all Manufacturing Facilities at Eyepoint
• May serve as the Quality Lead on program teams which includes product development teams and manufacturing operations.
• Experience leading Quality Event Management CAPAs and change control process
• Leads cross-functional teams in risk analysis associated with but not limited to Corrective and Preventative Actions (CAPA), Change Controls, complaint investigation, failure investigation (FMEA) and hazard assessments (HACCP)
• Expert knowledge and experience in leading teams in root cause analysis determination
• Lead, mentor, and develop a Quality Operations team
• Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence
• Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are defined and completed
• Arbitrate compliance discussions and negotiate any required corrective actions
• Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence
• Identifies, recommends, and implements enhancements to Quality Operations processes
• Collaborates with various functional teams to understand processes and use information to recommend process improvements
• Oversee the development, implementation, improvement and monitoring of quality processes and procedures to ensure that the product conforms to its specifications
• Manage and provide QA support for Process Validation activities
• Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.

• Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority
• Thorough understanding of Quality Systems, cGMPs, and other US regulations governing small molecule drug substances and drug products
• Must have ability to review, approve and critique protocols and reports of equipment, pharmaceutical, processes, and medical devices
• Experience with inspection readiness initiatives and in involvement with PAI inspections
• Ability to scale up current processes to support commercialization
• Demonstrated strong GMP experience with an understanding of all aspects of technical development and manufacturing from product development through commercialization, including validation
• Ability to work collaboratively in a fast-paced, dynamic work environment, while managing multiple priorities
• Proven track record advancing programs into and through clinical development (Phase I through commercialization) as a Quality lead
• Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment are essential
• Flexible and able to respond quickly to shifting priorities and meet deadlines
• Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment

• Experience auditing
• Experience in overseeing CMO operations
• Domestic Travel may be required to facilitate robust partnerships and execution
• Combination device experience
• Demonstrated management skills, including leadership, talent assessment, recruitment, employee retention and development

Level of

Education Required:

Bachelor’s degree required (Scientific discipline, or other technical disciplines); master’s degree a plus

• Minimum of 15 years of related experience in the pharmaceutical or…