Obsidian Therapeutics

Quality Operations Manager

Obsidian Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: Bedford • Massachusetts • United States

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Salary

💰 $129,000 - $157,500 per year

About the role

  • Support oversight of CDMOs to ensure adherence to Good Manufacturing Practices (GMP) regulations as well as Obsidian Therapeutics’ standards
  • Participate in Person in Plant activities.
  • Provide QA support for manufacturing operations including CMC, QA operations, and Supply chain and materials management.
  • Manage lot disposition - review batch data including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
  • Manage archive of batch records and other disposition supporting documents in internal document/record repositories.
  • Provide QA support for change controls, GMP investigations, associated CAPAs and Effectiveness Checks.
  • Facilitate resolution of Quality issues in a timely manner.
  • Lead the investigation/CAPA triage meetings (as necessary) and collaborate with CDMO and internal partners to ensure quality systems are monitored and established metrics are met.
  • Participate in IND preparedness, inspection readiness activities, and support regulatory site inspections.
  • Support development of quality metrics.
  • Participate in process improvement initiatives, perform gap analyses and communicate risks.
  • Provide compliance guidance to Obsidian project teams through collaborative review and working with the business owners to gain a better understanding of their needs.
  • Review applicable Supplier Quality Agreements.
  • Travel up to 20% to perform essential functions of the job.

Requirements

  • Bachelor’s degree in Biology, Chemistry, Engineering, life sciences or a related field, and 6+ years of relevant work experience (or M.S. and 4+ years of relevant work experience)
  • Strong knowledge of SOPs, associated CMC regulatory considerations and quality system processes
  • Proficiency in providing QA support and oversight of GMP manufacturing operations including batch release, experience with CDMO manufacturing and testing
  • Prior success in quality to quality interactions with CDMOs / CTLs Successful experience event investigations, Root Cause Analysis (RCA), and CAPA
  • Experience with both paper and electronic QMS systems
  • Excellent planning, coordination, and time management skills
  • Excellent oral, written, and visual communication skills
  • Ability to build and maintain productive relationships with department management, peers, and other colleagues across the organization
  • Ability to manage and deliver multiple projects in a fast-paced environment
  • A systems thinker. Approaches problem solving and process design from consideration of the overall system as well as its individual parts; considers interrelationships and patterns
  • Demonstrates context-based sound judgement.
Benefits
  • Competitive salary and benefits
  • Annual incentive bonus as a percentage of actual base salary
  • Long-term incentives in the form of employee stock options
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Good Manufacturing Practices (GMP)Quality Assurance (QA)CMC regulatory considerationsRoot Cause Analysis (RCA)Corrective and Preventive Actions (CAPA)Quality Management Systems (QMS)Batch releaseProcess improvementGap analysisSupplier Quality Agreements
Soft Skills
PlanningCoordinationTime managementOral communicationWritten communicationVisual communicationRelationship buildingProject managementProblem solvingSound judgement