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About the Role

We are seeking a Quality Assurance Operations professional to manage quality oversight at Drug Product Contract Manufacturing Organizations (CMOs). This role involves acting as the QA operations lead with assigned CMOs, reviewing manufacturing batch records and release certificates, and ensuring CMO SOPs and Master Batch Records comply with cGMPs. You will also serve as a technical reviewer for deviations, change records, protocols, and CAPAs.

Responsibilities

Represent QA Operations on internal and external project teams, audits, and inspections.
Monitor CMO performance.
Review and manage master and executed manufacturing batch records from CMOs, including release activities and related documents.
Author and perform quality review of SOPs and quality events (deviations/investigations, OOSs/OOTs, change controls, supplier notifications, etc.).
Lead Disposition of Drug Product.
Communicate and escalate manufacturing deficiencies/non-conformances to management.
Present issues during escalation.
Work with CMOs to ensure timely resolution of manufacturing issues.
Support review of regulatory filings.
Support audit of CMOs.

Requirements

Bachelor's Degree in a science discipline.
8+ years of experience within a biopharmaceutical company or contract research organization.
Strong knowledge of GMP, SOPs, Quality Systems (e.g. Lot Release, Deviation, Change Control, CAPA), ICH, and GxP principles.
Strong knowledge of FDA and other clinical trial regulations.
Prior experience in QC, Analytical Development, and process validation is highly desired.
Excellent verbal and written communication skills.
Strong customer focus.
Excellent organizational skills.
Ability to manage multiple tasks and competing priorities.
Ability to maintain meticulous attention to detail.
Travel up to 10%.

Skills

GMP
SOPs
Quality Systems
Lot Release
Deviation Management
Change Control
CAPA
ICH
GxP
FDA regulations
Clinical trial regulations
QC
Analytical Development
Process Validation
Communication
Organizational skills
Attention to detail

Location

San Francisco

Work Type

In-office collaboration 2-3x per week
Hybrid work model

Experience Level

8+ years of experience

Education Level

Bachelor's Degree in a science discipline

Salary/Compensations

$150,000—$175,000 USD

Benefits

Market-leading compensation
Annual performance bonus
Company equity
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for employee and dependents
Health Savings Account (HSA) with annual employer contributions
Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support
Flexible, take-what-you-need paid time off
Company-paid holidays
Comprehensive paid medical and parental leave
Skill development opportunities
Internal mobility opportunities
Career pathing
Continuous education
Professional development programs
Peer-to-peer recognition

About the Company

Pioneered a “moneyball for biotech” approach, pooling projects and early-stage research from academia under one financial umbrella to reduce risk and unleash innovation.
Builds bridges to groundbreaking advancements in rare disease.
Develops life-changing medicines for patients with unmet needs.
Defines white space, pushes boundaries, and empowers people to solve problems.
Asks "why not?" and helps reengineer the future of biopharma.
Values curiosity and experimentation, including the ethical and thoughtful use of AI.