Senior Quality Systems Compliance Specialist

Overview:

Be Seen and Heard at EyePoint

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
• transforming ocular drug delivery

• Your wellbeing
• Your professional worth
• Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

Provides guidance to the organization to drive compliance activities to ensure an inspection readiness status in the cGMP environment, ensuring compliance to policies and procedures for adherence with company standards and applicable local, state, federal, and international regulations governing drug products.

This position requires the person to travel to our Watertown, MA and Northbridge, MA sites 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:

Primary responsibilities include, but are not limited to, the following:

• 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. Works with functional owners to drive corrective actions and ensure the effectiveness of responses. Creates metrics to improve the performance of the self-inspection process.
• 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. Creates new processes and procedure aimed at continuous improvements and efficiency.
• Conducts ongoing surveillance of world-wide regulations, agency guidance documents, industry standards, new technologies and internal needs. Works with functional owners to ensure updates to procedures and policies to comply with the ever-changing regulatory environment.
• 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. Manages multiple compliance projects, realigning resources and priorities to meet challenging timeframes
• Independently applies advanced level of skill and broad knowledge of diverse related professional fields
• Has wide range of experience and is able to use Quality concepts and company objectives to resolve complex issues in an effective manner.
• Strong technical expertise of QA/QC and Manufacturing processes in order to support development and maintenance of cGMP compliant quality systems.
• Reflects solid understanding of strategies, goals and can take part in major parts of projects, or provide expert service
• 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

Qualifications:

Primary skills and knowledge required include, but are not limited to the following:

• 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

Level of Education Required: Bachelor of Science

Number of Years of Experience in the Function and in the Industry: A minimum of 5+ years Quality Auditing experience required in FDA regulated environment and 7 to 10 years’ experience working in a biopharmaceutical/pharmaceutical environment.

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

#LI-Hybrid