Senior Director, Quality Control

Obsidian Therapeutics

Senior Director, Quality Control leading QC strategies for clinical-stage cell therapy at Obsidian Therapeutics. Responsible for oversight and quality compliance in the development process.

Posted 5/15/2026full-timeBedford • Massachusetts • 🇺🇸 United StatesSenior💰 $232,000 - $280,000 per yearWebsite

About the role

Key responsibilities & impact

Develop and implement a phase-appropriate QC strategy and operations for clinical and commercial stages of development to support external manufacturing of autologous cell therapy products ensuring compliance with regulations and alignment with applicable global standards.
Serve as the QC subject matter expert (SME) for analytical methods, method qualification/validation, CMC strategy, regulatory filings, relationship management with external laboratory partners, and interactions with regulatory agencies. Ensure methods are fit-for-purpose, phase-appropriate, and robust for QC environments.
Define analytical control strategies for drug substance (DS) and drug product (DP), raw materials, in-process controls (IPCs), and release testing.
Champion continuous improvement to strengthen method lifecycle management, documentation practices, and analytical robustness.
Partner with External Manufacturing and QA Operations to manage and oversee contract testing laboratories (CTLs) and CDMOs; lead method transfer, qualification, testing, validation, and lifecycle management in line with business needs and quality and regulatory standards.
Support lot release and disposition decisions in collaboration with QA including QC input into Investigations and CAPAs, change controls (methods, specifications, materials), and stability programs.
Review and approve internal and external documents (including laboratory investigations, deviations, CAPAs, SOPs, validations, reports, forms, specifications, and certificates of analysis).
Interpret and present data, perform statistical analysis, and conduct trend assessments, participate in Quality Management Reviews.
Author and/or review CMC documents pertinent to quality control for regulatory submissions.
Lead QC support for Regulatory inspections for internal and external audits.
Oversee QC assessment of new raw materials and raw material qualification required to support GMP manufacturing and testing.
Establish department and individual goals and key performance indicators in alignment with company and operational goals.
Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues.
Develop and support a high performing team to execute department responsibilities; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee engagement and development, and philosophically aligned rewards and recognitions practices.
Drive a team culture of high standards, collaboration, empowerment, accountability, trust, and continuous learning.

Requirements

What you’ll need

PhD or MS in Biology, Biochemistry, or a related field, with 12+ years of experience in biopharma including cell therapy, demonstrating progressive responsibility in QC and Analytical Development or related function.
Expertise with cell-based potency assays, flow assays, immunoassays, molecular assays, and safety assays including rapid sterility and mycoplasma, and viral vector analytics.
Experience authoring and supporting BLA submissions.
Demonstrated success in leading outsourced/virtual QC models, partnering with Contract Manufacturing and Testing labs (CDMOS and CTLs) in technical transfer, qualification and validation of assays.
A track record of building and leading teams to deliver critical goals while adapting to changing priorities.
Exceptional communication skills in verbal, written, and visual formats, and adapted to the audience.
Excellent organizational skills; able to manage multiple tasks of varying degrees of complexity in parallel.
Ability to travel up to 20% of the time.

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

QC strategyanalytical methodsmethod qualificationmethod validationanalytical control strategiescell-based potency assaysflow assaysimmunoassaysmolecular assaysBLA submissions

Soft Skills

leadershipcommunicationorganizational skillscollaborationaccountabilitycontinuous learningrisk assessmentperformance managementemployee engagementadaptability