Qualifications
Key Responsibilities:Manage both internal and external quality operations to support GMP manufacturing activities for clinical and commercial purposes. Plan, organize, and lead all QA Operations activities including material release, batch record review, QC testing, lot disposition, Quality Event Management, and Annual Product Report reconciliation. Act as the Quality Lead on program teams, including product development and manufacturing operations. Lead Quality Event Management, CAPA, and change control processes effectively. Facilitate cross-functional teams in risk analysis related to CAPA, Change Controls, complaint investigations, failure investigations (FMEA), and hazard assessments (HACCP). Utilize expert knowledge in root cause analysis to guide team efforts. Mentor and develop the Quality Operations team, fostering a collaborative culture that enhances quality outcomes and operational excellence. Collaborate cross-functionally to ensure preparedness for pre-approval inspections and commercial readiness activities. Arbitrate compliance discussions and negotiate necessary corrective actions. Identify and implement enhancements to Quality Operations processes.
About the job
The Director of Quality Operations oversees global GMP quality at Eyepoint Pharmaceuticals, supporting both internal and external manufacturing. This position plays a key role in development and commercial programs, ensuring quality standards are consistently met across all operations. Reporting to the Senior Director of Global Quality Assurance, the Director leads both the Quality Operations and Quality Engineering teams. Daily responsibilities include providing direct support for quality-related activities and guiding team efforts to maintain compliance and operational excellence.
Location and schedule
This role is based at the Northbridge, MA facility. The company offers a hybrid work arrangement, requiring at least three days per week on-site. During major project milestones, on-site presence may be needed more frequently. The position also involves regular travel to the Watertown location, typically one to two times per week. Occasional travel to external partner sites is expected, accounting for approximately 5-10% of the time.
About Eyepoint Pharmaceuticals
At Eyepoint Pharmaceuticals, we are dedicated to advancing the field of ophthalmology through innovative therapeutic solutions. Our team is committed to quality, and we strive to maintain the highest standards in all our operations. Join us in our mission to improve patient outcomes and drive success in the pharmaceutical industry.
