Senior Manager, Quality Compliance
Obsidian Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Bedford • Massachusetts • United States
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Salary
💰 $151,500 - $185,000 per year
Job Level
About the role
- Own the Quality Compliance and Audit programs to ensure alignment with FDA, ICH, and applicable GxP regulations
- Maintain phase-appropriate and risk-based quality systems across Technical Operations, Supply Chain, and Quality functions as well as with GMP CDMO suppliers
- Prepare for, schedule, and conduct audits of Obsidian’s GMP suppliers including CDMOs, contract testing laboratories, logistics providers, and other suppliers
- Generate an audit report and report findings to management and impacted stakeholders
- Follow up with audit findings to ensure effective remediation and CAPA execution, ensuring overall supplier performance
- Trend audit findings to identify systemic issues and improvement opportunities and report at Management Review
- Execute internal audits and support regulatory inspections as necessary
- Onboard and qualify new suppliers and establish Quality Agreements with suppliers as necessary
- Regularly maintain the Approved Supplier List
- Author, review, and maintain SOPs governing Supplier Management, Audits, Quality Agreements, Supplier Corrective Action Requests, and Regulatory Inspections
- Champion a proactive quality culture focused on accountability, transparency, and risk-based decision-making
- Up to 30% business travel (essential requirement)
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related discipline with 8+ years of relevant work experience (or M.S. and 6+ years of experience)
- 4+ years of biopharmaceutical experience in a related Quality function, cell or gene therapy strongly preferred
- Direct auditing experience of GMP suppliers such as CDMOs or contract testing laboratories
- Experience in clinical-stage environments
- Excellent knowledge and understanding of applicable GXP regulations
- Strong record-keeping and organizational skills, including an ability to manage multiple responsibilities in parallel
- A highly collaborative working style
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality ComplianceAudit programsGMPGxP regulationsSOPsCAPA executionRisk-based decision-makingSupplier ManagementClinical-stage environmentsBiopharmaceutical experience
Soft Skills
Organizational skillsCollaborationAccountabilityTransparencyCommunicationProblem-solvingAttention to detailTime managementLeadershipStakeholder engagement