Senior Quality Systems Compliance Specialist

EyePoint Pharmaceuticals - Northbridge, MA

Full-time - Mid Level

Hybrid - Northbridge, MA

Chemical Manufacturing

About the position

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for preventing blindness through vision-saving medications, delivering best-in-class proprietary pharmaceutical technologies, and transforming ocular drug delivery. Reporting to the Manager, Quality Systems and Compliance, the QS Compliance Specialist will have responsibility for compliance within the organization and related processes within the range of development, laboratory and manufacturing operations. This position is based in Northbridge and requires the person to travel to our Watertown, MA and supplier facilities in the US and potentially Europe. Travel requirements are 50%. The person needs to possess a valid driver's license. We offer a hybrid work schedule.

Responsibilities

• Collaborating with Quality Leadership to gain insight into organizational goals, priorities, and requirements.
• Oversee Supplier Quality Management (SQM) including Approved Supplier List and supplier auditing.
• Perform required lead auditor or support auditor activities as applicable for assigned audits.
• Prepare written audit reports and documents in accordance with company and department procedures and requirements.
• Oversees and executes the self-inspection audit program for all GMP areas to assure compliance with policies procedures and regulatory requirements.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
• Generate and drive activities for the development, review, and approval of Annual Product Review (APR) reports.
• Actively engages with the organization and directs quality improvements, evaluating multiple perspectives.
• Conducts ongoing surveillance of world-wide regulations, agency guidance documents, industry standards, new technologies and internal needs.
• Manages the Product Recall processes including the development and maintenance of procedures associated with these processes.
• Responds timely to compliance concerns and oversees problem resolution to completion.
• Independently applies advanced level of skill and broad knowledge of diverse related professional fields.
• Provide guidance and support in the development of corrective and preventive actions based on GxP requirements and industry standards.
• Review and revise relevant policies and procedures to maintain adherence to regulations.
• Maintain current knowledge of regulations, standards, and guidance documents.
• Support external and supplier audits as required.
• Support Audits and Inspections of Eyepoint.
• All other duties as assigned.

Requirements

• Must be Certified Auditor (21 CFR Parts 210 / 211 / EU ICH experience required)
• Extensive knowledge of US and EU cGMP regulations and guidance
• At least 7+ FDA regulated industry preferred
• Minimum of 5+ years auditing experience
• Proven experience in GMP auditing associated with chemical API and excipient manufacturers and suppliers; packaging suppliers; Drug Product and Medical Device component manufacturers
• Extensive experience in Quality Management Systems and risk-based auditing within a pharmaceutical manufacturing organization
• Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups
• Effective organizational and planning skills with ability to meet deadlines required
• Knowledge of basic statistical and engineering principals is essential