Aera Therapeutics was founded by a world-class team of scientists, investors, and company builders with a shared vision to unlock the potential of genetic medicines across a broad range of modalities and therapeutic areas. We strive for excellence and an industry-leading position in our chosen delivery platforms, while aggressively hunting for opportunities where enabling delivery technologies can unlock applications of high, unmet medical need.

Leveraging deep expertise in the space, Aera has a leading LNP platform that enables today’s applications, while investing in and developing a potentially disruptive PNP platform to enable tomorrow’s applications.

How will your role make an impact at Aera Therapeutics? Aera is seeking a Director of Quality Operations to lead all Quality oversight activities in a fully outsourced GxP environment. The successful candidate will ensure that Aera's external partners (CDMOs, CTLs, CROs) meet phase appropriate compliance requirements, while strengthening Aera's internal QMS and effectively managing our team of Quality consultants.

This role is both strategic and hands-on, and is critical to building the robust, phase appropriate Quality organization as we advance our novel genetic medicines into the clinic. You will report to the VP, Head of CMC and be expected to be onsite 4-5 days per week.

You will:

Lead Quality Oversight for AERA-109 and Pipeline Programs
- Serve as the Quality Lead for all CMC/GMP, GLP, and GCP activities supporting AERA-109 (Aera's novel targeted in vivo CAR T therapy)
- Establish a Quality framework for Aera's expanding pipeline, including next generation tLNP and AOC programs

Strengthen and Scale Aera's Quality Management System
- Own and optimize in a phase-appropriate manner Aera's eQMS
- Manage eQMS workflows executed by Aera team members and Quality consultants
- Implement and maintain a phase- and function-appropriate training program for internal GxP employees

Lead Quality Oversight of External GxP Vendors
- Drive risk-based oversight of all external GxP partners (CDMOs, CTLs, and CROs), including vendor qualification and audit activities
- Maintain and improve Aera's vendor management program
- Negotiate, implement, and manage Quality Agreements

Drive Regulatory Submissions & Inspection Readiness
- Author and review Quality-related sections of regulatory submissions.
- Serve as the Quality Lead during mock inspections, audits, and regulatory interactions.

Provide Cross-Functional Leadership & Manage a Hybrid Quality Model
- Partner closely with CMC, Clinical Operations, Regulatory, and R&D teams to ensure operational efficiency and adherence to Quality requirements
- Effectively leverage Aera's team of QA/QC consultants to meet Quality goals across programs

Qualifications:

Bachelor's Degree and 12+ years of QA experience, or Master's degree with 10+ years of QA experience, including 5+ years in a Quality leadership role in biotech (biologics, RNA therapeutics, LNP based modalities)

Proven track record advancing programs into and through clinical development (Phase I through commercialization) as a Quality lead

Demonstrated success managing fully outsourced GLP, GMP, and GCP models

Deep working knowledge of global GxP regulations, including:
- GMP: 21 CFR 210/211, 600–680, FDA Phase 1 CGMP; EU/PIC/S GMP; ICH Q7/Q8/Q9/Q10
- GCP: 21 CFR 50/56/312; ICH E6
- GLP: 21 CFR 58; OECD GLP
- Data Integrity / 21 CFR Part 11
- CMC guidance for biologics & genetic medicines

Manage Quality consultants within a hybrid QA model

Previous authorship of regulatory submissions with FDA, MHRA, and/or EMA

Ability to travel internationally 10-20%

Knowledge of ChP requirements
Commitment to our Core Values: Respect, Integrity, Excellence, Impact

The approximate salary range for this role is $200,000 - $222,000

Our salary ranges are determined by job scope, level, and location. The range displayed on this job posting reflects the minimum and maximum target for new hire salaries for the position as posted. Within the range, individual pay is determined by a variety of factors, including job-related skills, experience, relevant education or training, and business need. In addition to the base salary, eligible employees will have an opportunity to participate in an annual cash bonus, equity incentives, and a robust benefits offering that includes health insurance, 401k retirement plan with company match, paid sick and vacation time, life and disability insurance, and commuting expense reimbursement.

Aera Therapeutics is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, protected veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.

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