Associate Director, QC Operations – Cell Therapy

Obsidian Therapeutics

Associate Director of QC Operations overseeing drug product manufacturing at Obsidian Therapeutics. Leading a quality team in regulatory compliance and operational excellence for cell therapies.

Posted 5/29/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $175,000 - $214,500 per yearWebsite

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Hard Skills

analytical method transferphase appropriate validationGMP complianceQC analytical methods optimizationpotency assayimmunoassaysflow cytometryPCRdata trendingquality metrics

Soft Skills

ownershipaccountabilityeffective communicationorganizational skillsflexibilitysystems thinkingsound judgementcollaborationself-motivationresilience

Industry Keywords

biologicscell therapygene therapyFDA guidelinesEMA guidelinesICH guidelinescontract test laboratoriesquality eventsBLA preparatory activitiesCDMO

About the role

Key responsibilities & impact

Provide strategic and operational leadership for Drug Product programs supported through external manufacturing and testing partners.
Build systems/processes and organize resources to establish and achieve product release cycle times
Provide QC oversight of CDMOs and contract test laboratories (CTLs)
Direct and oversee method validation and transfer activities, including tech transfer to an external CDMO, to ensure GMP compliance
Assist with PPQ readiness and BLA preparatory activities
Lead QC investigation of quality events including laboratory investigations, OOS/OOT and deviations, and support manufacturing investigations at CDMOs and CTLs
Support development of specifications for raw material, drug substance, intermediate and final product testing, and stability testing
Author and review test methods, protocols, reports, and associated documents
Support data trending and quality metrics
Support regulatory submission activities
Collaborate closely with QA, Regulatory, Supply Chain, MSAT, AD, and PD groups and external key partners
Monitor and evaluate external laboratory performance using KPIs, driving improvements in efficiency and right-first-time execution
Assist with continuous improvement of quality and compliance
Regularly perform QC Person In Plant activities at Obsidian’s CDMO facilities, and other duties as needed.

Requirements

What you’ll need

Bachelor’s degree in biology, chemistry, life sciences or a related field, and 10+ years of analytical experience in biologics or CGT in an industry setting (or M.S. and 8+ years of experience)
At least 6 years of experience in a GMP setting
Expertise with analytical method transfer and phase appropriate validation/qualification
Familiarity with relevant FDA/EMA and ICH regulatory guidelines relevant to gene and cell therapy, analytical development, and method validation
Experience enabling and overseeing contract test laboratories for cell and/or gene therapy products and managing quality events and investigations
Experience with late phase to commercial programs (cell therapy, gene therapy or biologics)
Experience with QC analytical methods optimization and troubleshooting for cell and gene therapy products including potency assay, immunoassays/flow cytometry, PCR, etc.
A clear sense of ownership and accountability to meet commitment and high standards promoting the same with CDMO partners
Ability to communicate effectively with scientific/technical colleagues in a dynamic, cross-functional environment
Excellent organizational skills, with a proven ability to manage multiple matrixed projects and tasks to completion in a fast-paced environment, anticipating risks and obstacles and adjusting to effective contingency plans
Flexibility - ability to adapt to changes and priorities to fulfill our mission, including after-hours or weekend support for batch release when required to deliver product to a patient
Systems thinking - You approach problem solving and process design with consideration of the overall system as well as its individual parts, considering interrelationships and patterns.
A track record of context-based sound judgement, including when to elevate risks and issues to leadership
An ability to be on-site at CDMO up to 30-40% of time
Collaborative and accountable – recognizes success requires interdisciplinary thinking and teamwork; shares feedback and ideas, productively challenges own and others’ assumptions to facilitate better outcomes
Self-motivated, with a proven ability to work with general direction to meet objectives and timelines, managing multiple responsibilities in parallel.
Curious and humble – seeks and welcomes input/expertise of others, continuous learner
Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments.

Benefits

Comp & perks

Comprehensive medical, dental, and vision coverage
Company contributions to health savings and retirement accounts
Ample paid time off
Access to wellness programs
Rich career growth opportunities
Annual incentive bonus as a percentage of actual base salary
Long-term incentives in the form of employee stock options