Product Quality Assurance Manager

Job Description:

JOB TITLE: Product Quality Assurance Manager

LOCATION: Remote - Remote candidates based in the following states will be considered: IN, MA, NC, NH, NM, NY, PA, SC, SD, TX, KY, or WA.

SALARY RANGE: $106,000 to $115,000. The midpoint of the range is $110,000. The ideal candidate would be hired at or around the midpoint.

ABOUT THE POSITION

This is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy and cornea care innovation. As a Product Quality Assurance Manager, you will play a critical role in accomplishing this mission and in staging Aurion Biotech’s novel cell therapy treatment for successful launch in the United States.

We are seeking an experienced Product Quality Assurance Manager to work collaboratively with internal and external stakeholders to drive execution of project milestones. Primary responsibilities include oversight of the internal Quality Management Review program, tracking of Quality Department projects to ensure completion according to project milestones, and being a liaison between Aurion Quality and our external CDMO partners. This position reports to the Product Quality Lead.

KEY RESPONSIBILITIES

Quality Systems Management

• Serve as Subject Matter Expert for the Quality Management Review (QMR) Quality System
• Drive the preparation, facilitation and documentation of QMR meetings
• Develop, track, and report on internal and external key Quality metrics to monitor QMS effectiveness and identify areas for continuous improvement
• Work with cross-functional managers to create, harmonize and maintain Key Performance Indicator (KPI) dashboards for use in QMR meetings

Quality Oversight and Project Management

• Track the BLA-enabling Quality project milestones, working with internal and external stakeholders to ensure timely completion of deliverables
• Independently monitor the Quality program milestones to identify any risks to critical path timelines. Escalate timeline delays to Management
• Manage and track sample shipment request submissions at CDMO and CTL partners in support of internal QA/QC functional area needs
• Review and approve phase appropriate tech transfer documentation, external deviation investigations and/or external change control, as needed
• Prepare for and facilitate weekly internal Quality Assurance meetings, ensuring action items are tracked and completed on time
• Support Quality performance/continuous improvement activities
• Other duties as assigned

ABOUT AURION BIOTECH

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

• Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
• Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
• Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.

Aurion Biotech has a lot to accomplish in the next few years and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 2-3 years’ experience in Quality Assurance, Quality Control or other related function with a Master of Science in Biochemistry, Chemistry or other relevant scientific disciplines preferred
• 5+ years’ experience in Quality Assurance, Quality Control or other related function with a Bachelor of Science in Biochemistry, Chemistry or other relevant scientific disciplines preferred
• Experience with Quality Management Review requirements as defined by ICH Q(10) required
• Experience with tech transfer and late-stage development preferred
• Excellent working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FA, ICH) required
• 1-2 years’ experience working with program management software (Smartsheet, MS Project, or equivalent) required. PMP Certification preferred, but not required
• Experience working with internal cross-functional teams and external partners preferred

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Demonstrated proficiency with managing project timelines and ensuring deliverables are met, adapting to rapid change as needed
• Ability to work cross-functionally with excellent verbal communication and collaboration skills
• Strong written and oral communication skills with ability to summarize scientific data in a logical, organized, clear and persuasive manner
• Quality mindset with demonstrated ability to address compliance gaps
• Advanced proficiency in use of MS Office and Project Management software
• Ability to work effectively both independently and with other team members