Quality Manager, Combination Product and Medical Devices

About Aura:

At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.

We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including metastases to the choroid. Leveraging our VDCs’ broad tumor targeting capabilities, we have initiated a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.

Position Summary:

Aura Biosciences is recruiting for a Quality Manager, Combination Products and Medical Devices. The Quality Manager will be responsible for maintaining compliance with global standards and regulations including ISO 13485, 21 CFR Part 820 and 21 CFR Part 4. The successful candidate will have extensive experience in medical device and/or drug-device combination product development (design control, risk management, etc.), Quality Systems, and support of ongoing clinical trials in all phases. 

Responsibilities include but are not limited to:

• Serve as the Quality leader for combination products and medical devices and development projects, with a strong emphasis on design control and risk management.
• Participate in cross-functional teams as the combination products and medical devices Quality representative supporting all phases of product development from feasibility to commercialization.
• Facilitate and participate in the risk management process supporting documentation compliant with applicable regulations and standards.
• Partner with external manufacturers providing finished products, services, components, and clinical devices to ensure compliance to internal and external requirements and regulations.
• Partner with Clinical Development, CMC, R&D, Supply Chain, Regulatory, Clinical Operations and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.
• Lead and implement complex projects including Quality Improvement initiatives.
• Set direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• Contribute to and review Design History Files for Combination Products.
• Act as a resource for colleagues in explaining design control and risk management concepts and requirements; may include advising both technical and QA teams on the best approaches to problems.
• Assist in preparation of global regulatory submissions, documentation, technical files, etc.
• Support audits of device constituent suppliers and prepare Aura’s QMS for commercialization and audit readiness according to 21 CFR Part 4 and ISO 13485.
• Support all aspects of clinical trials for combination products and medical devices, including protocol review, monitoring activities, risk management, and device deficiency resolution.

Minimum Requirements:

• BS in a life science or engineering field required.
• 5 years of direct GMP device development/manufacturing experience (combination products strongly preferred).
• Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products.
• Solid understanding and application of FDA and international regulations, GMPs and relevant ISO standards.
• Excellent written and verbal communication skills.
• Experience writing and approving CAPAs, change controls, and root cause analyses.
• Well organized, self-motivated, and independent work style with the ability to initiate and follow through on assignments.
• Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments.
• Ability to manage changing priorities in a fast-paced environment.

Salary & Benefit Information

Salary Range: $110,000/yr - $150,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity.)

• Health insurance with FULL premium coverage
• 401K with company match
• Employee Stock Purchase Program (ESPP)
• Competitive Paid time off (PTO)
• Company-paid short & long-term disability insurance and life insurance

Salary : $110,000 - $150,000