Manager, QA Compliance

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

What You'll Do

The Manager of QA Compliance, reporting to the Director, QA Compliance, responsible for the development, review, execution, and maintenance of the Quality Agreement.  Support internal and external audit operations, inspection readiness, and compliance metrics. This role requires strong cross-functional collaboration with CMC, Quality Control, Supply Chain Management, Regulatory Affairs, Legal, Contract Service Providers, and other functional areas as needed.

Responsibilities

• Lead and manage global Quality Agreements/QTAs by developing, reviewing, executing, and maintaining agreements, ensuring compliance with the scope of services, regulatory requirements, internal standards, and all terms and conditions

• Collaborate with internal cross-functional teams and external stakeholders (e.g., contract service providers) to bring Quality Agreements to an approvable state

• Track Quality Agreement renewal and revision cycles

• Support regulatory authority inspection readiness activities at CSP and internally.

• Participate in the global supply chain vendor qualification process to ensure compliance with regulatory and internal standards

• Participate in the planning of internal audits

• Ensure audit findings are followed up on, corrective actions are completed, implemented, and verified to ensure compliance

• Identify and assess risks to compliance, develop mitigation strategies, and ensure effective implementation

• Maintain master vendor list with up-to-date Health Authority certification/licenses

• Maintain risk registers and communicate risk trends to Quality leadership

• Develop, track, analyze, and present Quality Compliance metrics, including audit data, CAPA performance, Quality Agreement KPIs, risk assessments, and vendor performance indicators

• Prepare quality dashboards and monthly/quarterly reports for management review

• Support SOP development and revision related to Quality Agreements, auditing, risk management, and metrics

• Other duties as assigned

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Bachelor's degree in a scientific discipline; an advanced degree is a plus

• A minimum of 8+ years of experience working in a Biotech or Pharmaceutical FDA-regulated industry in QA or a related field, or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained

• Hands-on experience drafting commercial Quality Agreements with various scopes of services.

• Prior experience in vendor qualification processes

• Excellent communication, relationship-building, and technical writing skills

• Strong knowledge of global GxP regulations (FDA, EMA, ICH).

• Prior experience in leading/supporting PAI readiness activities

• Ability to work in a virtual environment

• Ability to thrive in a dynamic, fast‑paced, cross‑functional environment.

• Willingness to travel both domestically and internationally as required.

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 

• 401K with 100% employer match on first 3% & 50% on the next 2%

• Employee stock purchase program

• Pre-tax commuter benefits

• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents

• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)

• Hybrid work model - employees have the autonomy in where and how they do their work 

• Unlimited flexible paid time off - take the time that you need

• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents

• Flex spending accounts & company-provided group term life & disability 

• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities