Obsidian Therapeutics · 11 hours ago
Associate Director, Clinical Quality
Cambridge, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$172K/yr - $210K/yr
10+ years expObsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. The Associate Director, Clinical Quality will be responsible for the development and execution of a GCP Clinical Quality Assurance program to ensure compliance with applicable regulations and support clinical trials in metastatic melanoma and non-small cell lung cancer.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Define and implement a risk-based GCP quality management system as part of Obsidian’s overall Quality Management System
Develop an audit program and conduct internal and external GCP audits of clinical investigator sites and vendors, TMFs, and laboratories to assess compliance, completeness and adherence to GDP and data integrity
Manage the audit lifecycle activities such as scheduling, planning, issuing agendas, audit execution, issuing audit reports, evaluating responses and CAPA, and audit closure
Present audit findings and/or other related audit information to appropriate departmental personnel, as required; escalate serious non-compliance issues to senior management
Work directly with auditees to ensure completion of corrective and preventative actions to address compliance concerns identified during audits
Identify non-compliance trends, gaps and implement mitigation strategies
Review study documents such as clinical protocols, IBs, ICFs and other documents to assess GCP compliance
Support investigation and closure of GCP related deviations/quality events/CAPAs
Collaborate with Clinical Operations, Technical Operations teams and CRO counterparts as needed, including participation in study team and QA meetings
Support Quality Management in inspection readiness activities and collaborate with study and functional area teams as needed; support the conduct of mock inspections and related activities; provide inspection preparation training to internal staff, clinical investigator sites, and vendors
Lead and/or support strategic organizational quality and compliance process improvement initiatives
Other duties as assigned
Estimated travel: 20-30%
Qualification
Required
Bachelor's degree in a scientific discipline and 10+ years of relevant experience, including 5+ years in GCP Clinical Quality Assurance
Experience independently conducting internal and external GCP audits (i.e., investigator site audits, process and vendor audits, etc.)
Excellent knowledge of ICH GCP and appliable CFR regulations with a working knowledge of GLP
Experience developing SOPs for risk-based quality management and quality by design for Phase I, II and III clinical trials
A clear sense of ownership and accountability to meet commitments and high standards promoting the same with clinical sites, vendors, and labs
Excellent planning, coordination, and time management skills
Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership
Ability to build and maintain productive relationships with department management, peers, and other colleagues across the organization
A track record of context-based sound judgement, including when to elevate risks and issues to leadership
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
Preferred
Oncology and cell and gene therapy experience ideal
GLP audit experience is a plus
Prior experience in CRO is a plus
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
Company
Obsidian Therapeutics
Obsidian Therapeutics is a developer of a next-generation cell and gene therapies created to extend adoptive immunotherapy.
51-200 employees
H1B Sponsorship
Obsidian Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (3)
2022 (2)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$325MKey Investors
Wellington ManagementThe Column GroupGoogle Ventures
2024-04-03Series C· $160.5M
2021-09-09Series B· $115M
2017-12-06Series A· $49.5M
Leadership Team
Madan Jagasia
Chief Executive Officer
Kirsten Kester
Senior Vice President, Business Development
Recent News
DelveInsight Business Research LLP
2025-10-14
2025-10-09
Company data provided by crunchbase