Serve as the quality lead for commercial packaging operations at assigned CSPs, providing oversight across primary/secondary packaging, labeling, and serialization to ensure GMP and GDP compliance.
Review executed batch records and compile batch documentation packages to support lot disposition and market release.
Provide quality review of deviations, change controls, CAPAs, and risk assessments related to packaging operations.
Review and provide quality input on tech transfer, process validation, and shipping qualification protocols and reports through preparation, execution, and closure.
Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution.
Support review of CMC sections and regulatory filings.
Author, review, and maintain QA Operations SOPs and controlled documents.

Bachelor’s degree in a scientific discipline with 6+ years of experience within a biopharmaceutical company and at least 4+ years in Quality Operation roles in a current Good Manufacturing Practices (cGMP) environment.
Strong working knowledge of FDA regulations (21CFR, 210/211), ICH guidelines, and global regulations (EU Directives, and ROW) and expertise in the cGMP requirements pertaining to manufacturing and packaging operations (including serialization) in the United States and globally in support of global commercial production activities.
Experience with Veeva platform highly preferred.
Strong communication and collaboration skills with the ability to influence stakeholders in a matrix environment.
Ability to exercise good judgment and make decisions that align with organizational objectives.
Results-driven mindset, taking initiative and ownership of assigned tasks.
Demonstrated flexibility and adaptability in a dynamic, rapidly growing environment.
Commitment to continuous improvement and embracing innovative approaches in daily work.
Up to 15% domestic and international travel required.

Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family

Manager, QA Operations

Key skills