Senior Quality Systems Compliance Specialist

Eyepoint Pharmaceuticals - Watertown, MA

Full-time - Mid Level

Hybrid - Watertown, MA

Chemical Manufacturing

About the position

The QS Compliance Specialist at EyePoint is responsible for ensuring compliance within the organization, particularly in development, laboratory, and manufacturing operations. This role involves driving compliance activities to maintain inspection readiness in a cGMP environment, adhering to local, state, federal, and international regulations governing drug products. The position requires collaboration with Quality Leadership and involves travel to various sites and supplier facilities.

Responsibilities

• Collaborate with Quality Leadership to understand organizational goals and requirements.
• Oversee Supplier Quality Management (SQM) including the Approved Supplier List and supplier auditing.
• Perform lead auditor or support auditor activities for assigned audits.
• Prepare written audit reports in accordance with company procedures.
• Execute the self-inspection audit program for all GMP areas to ensure compliance with policies and regulations.
• Drive corrective actions and ensure effectiveness of responses with functional owners.
• Create metrics to improve the self-inspection process performance.
• Assess adequacy of responses to audit findings in cooperation with stakeholders.
• Generate and drive activities for the development and approval of Annual Product Review (APR) reports.
• Engage with the organization to direct quality improvements and evaluate multiple perspectives.
• Create new processes aimed at continuous improvements and efficiency.
• Conduct ongoing surveillance of regulations, agency guidance, and industry standards.
• Ensure updates to procedures and policies to comply with regulatory changes.
• Manage the Product Recall processes and associated procedures.
• Respond to compliance concerns and oversee problem resolution.
• Manage multiple compliance projects and realign resources as needed.
• Apply advanced skills and knowledge to resolve complex issues effectively.
• Provide guidance in developing corrective and preventive actions based on GxP requirements.
• Review and revise policies and procedures to maintain regulatory adherence.
• Support external and supplier audits as required.

Requirements

• Certified Auditor (21 CFR Parts 210 / 211 / EU ICH experience required).
• Extensive knowledge of US and EU cGMP regulations and guidance.
• At least 7+ years in FDA regulated industry preferred.
• Minimum of 5+ years auditing experience in GMP environments.
• Proven experience in GMP auditing for chemical API, excipient manufacturers, and packaging suppliers.
• Extensive experience in Quality Management Systems and risk-based auditing in pharmaceutical manufacturing.
• Excellent oral and written communication skills for clear reporting and presentations.
• Effective organizational and planning skills to meet deadlines.
• Knowledge of basic statistical and engineering principles is essential.
• Bachelor of Science degree.

Benefits

• Hybrid work schedule
• Robust total rewards package
• Opportunities for professional development
• Supportive work environment that values diversity and inclusion