At Obsidian, our vision is pioneering engineered cell & gene therapies to deliver transformative outcomes for patients.

Associate Director, Clinical Quality

DirectorDirectorFull TimeRemoteSeniorTeam 51-200H1B SponsorCompany Site LinkedIn

Location

Massachusetts

Posted

98 days ago

Salary

$171.5K - $210K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishGoogle Cloud Platform

Job Description

• 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%.

Job Requirements

Bachelor’s degree in a scientific discipline and 10+ years of relevant experience, including 5+ years in GCP Clinical Quality Assurance.
Oncology and cell and gene therapy experience ideal.
Experience independently conducting internal and external GCP audits (i.e., investigator site audits, process and vendor audits, etc.). GLP audit experience is a plus.
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.
Prior experience in CRO is a plus.
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.