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

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

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
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

Manager, QA Compliance

Key skills