Director, Quality Engineer

Watertown, MA, United States

Overview:

Be Seen and Heard at EyePoint Pharmaceuticals

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach were taking in business fuels our success for:

preventing blindness through vision-saving medications

delivering best-in-class proprietary pharmaceutical technologies

transforming ocular drug delivery

We See You.

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. Theres 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.

As the Director of Quality Engineering reporting to the VP, Quality; this position will play a pivotal role in ensuring the quality and regulatory compliance of our products by championing the implementation of processes, protocols and methods which ensure the reliability of our products. This position leads the Quality Engineering team who will develop requirements for inspection and test of finished goods, in-process, raw materials as well as oversight of the validation activities for the facility and equipment which produces our products. Ensuring compliance with internal and external safety, quality, and regulatory standards is a top priority.

This position will serve both our Watertown and Northbridge locations.

Responsibilities:

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

Individual responsibilities

Provides overall leadership for Quality Engineering (QE) associated with pharmaceutical development process approaches, design controls, and standard practices. Maintains alignment with US and International regulations and standards, as well as EyePoint quality systems.

Oversee the development, implementation, improvement and monitoring of quality processes and procedures to ensure that the product conforms to its specifications.

Understand and support the post-market surveillance activities over the course of the product lifetime. Monitoring improvements and changes throughout.

Be an effective member of the cross-functional organization to foster a culture of continuous quality compliance, cost, and predictive measures improvements.

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.

Provide hands-on expertise in the day-to-day management of employees, data and documents within the GXP Quality Engineering team.

Serves as the QE Lead on program teams which includes product development teams and manufacturing operations.

Works with the VP, Quality to strategically plan for correct staffing to meet company demands, ensures that the group is current on all training.

Works with the Director of Quality Assurance and the Director of Quality Control to develop metrics for inspection as well as management review.

Leads QE team in risk analysis associated with but not limited to Corrective and Preventative Actions (CAPA), Change Controls, complaint investigation, failure investigation and hazard assessments.

Leads QE Team in preparing documentation for inspection/testing procedures.

Develops processes and tests to ensure that appropriate incoming and in-process inspection and controls are being performed.

Propose, initiate and prepare SOPs and other governance documents.

Collaborate with other subject matter experts across the R&D and Tech Ops organizations to conduct cross-functional investigations, risk management and mitigation plans to ensure on time execution of activities and team timeline adherence.

All other duties as assigned.

Qualifications:

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

Experience in the biotechnology and/or pharmaceutical industry, preferably both.

Experience managing multiple functions within a quality organization

Knowledge of basic statistical and engineering principals is essential Minitab experience is a plus

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.

Routinely exercises sound judgment, reasoning and problem solving.

Flexible and able to respond quickly to shifting priorities and meet deadlines.

Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).

Thorough understanding of Quality Systems, cGMPs, and other US regulations governing drug products.

Experience leading, training and/or implementing root cause analysis and effective investigation practices.

Lead and influence individuals from multiple functional departments at all levels of the organization.

A strong team player with a servant leadership mindset.

Strong organizational and time-management skills to balance working on multiple projects and initiatives in parallel.

Excellent people leader with strong mentorship skills.

Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment.

Attention to detail, excellent written and communication skills.

Working knowledge of global GxP regulations.

Other Requirements:

Auditor certification

Experience in CMO operations.

Domestic Travel will be required to facilitate robust partnerships and execution.

Depending on growth of organization and the primary work location, travel is estimated to be 5-15%.

Level of Education Required:

Bachelors degree required (Engineering, or other technical disciplines); master's degree a plus.

At least 8 years experience in increasingly more senior roles in Quality Engineering, R&D, Engineering Operations, Validation, preferably within pharmaceutical, medical device, and/or combination products.

Extensive experience in pharmaceutical development and medical device development and commercialization in a start-up environment to successful product launches.

Strong working knowledge of CFRs and EU regulations.

Must have ability to review, approve and critique protocols and reports of equipment, pharmaceutical, processes, and medical devices.

Expertise in process development, design control, reliability testing, and quality tools.

Extensive experience with risk management and FMEAs.

Strong interpersonal and communication skills for effective collaboration.

Experience with setting up a reliability program.

Experience and working knowledge of relevant compliance standards and associated product testing.

Demonstrated management skills, including leadership, talent assessment, recruitment, employee retention and development.

Number of Years of Experience in the Function and in the Industry:

8 - 14 years in FDA regulated 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.

S uccess begins with our People

P atients First

I ntegrity

R esults-Driven

I nnovation

T eam Focus

D iversity & Inclusion

EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. 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.

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