Atrium · 2 hours ago
Senior Quality Specialist, Clinical Distribution
Boston, MA
Contract
Onsite
Senior Level
$55/hr - $65/hr
5+ years expAtrium is seeking a highly motivated and experienced Senior Quality Specialist to serve as a key subject matter expert in Good Distribution Practice for the global clinical supply chain. The role involves ensuring compliant storage, handling, and distribution of critical clinical supplies, while managing vendor relationships and overseeing quality events.
Real Estate
Responsibilities
Responsible for ensuring the compliant storage, handling, and distribution of critical clinical supplies - including small molecules, cell & gene therapies (CGT), and biologics/devices - from depot to patient
Primary quality point of contact for temperature-controlled logistics, quality event management, and vendor oversight, ensuring our clinical trial materials maintain their integrity and efficacy
Partnering closely with our internal partners such as clinical supply chain, clinical/GCP operations, GMP/manufacturing and Regulatory Affairs
Serve as the SME for GDP compliance across GDP vendors, for storage and distribution activities across modalities
Maintenance of SOPs, work instructions
Application of relevant global regulations and guidelines (FDA, EU GDP, ICH GCP, etc.) to clinical distribution activities
Manage the quality relationship with clinical GDP vendors
Support vendor audits and qualification activities
Review and approve quality agreements
Oversee vendor performance through quality metrics
Provide support on programs, phases 1 to 3, across modalities, globally
Attend program meetings, provide functional updates
Support quality event investigations (root cause analysis, product impact, CAPA effectiveness and disposition), including temperature excursions
Support change management
Maintain KPIs for clinical GDP performance
Analyse trends to proactively identify risks and drive continuous improvement initiatives
Prepare and present quality metrics and updates
Qualification
Required
Bachelor's degree in a Life Sciences, Pharmacy, Engineering, or related field
Minimum of 5+ years of experience in a GxP Quality role within the pharmaceutical or biotechnology industry, with at least 3 years focused specifically on clinical GDP
Demonstrated hands-on experience managing temperature excursions and conducting quality investigations in a clinical supply context
Proven experience in vendor management
Strong knowledge of US FDA and EU GDP regulations governing clinical supplies and ICH GCP guidelines
Excellent technical writing skills for SOPs, investigation reports, and quality agreements
Company
Atrium
Atrium is a global WBENC-certified Talent Solutions and Extended Workforce Management leader.
201-500 employees
H1B Sponsorship
Atrium 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
2021 (2)
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Caylon Joiner
Talent Acquisition Partner
Shannon Mooney
Managing Director, Strategic Partnerships
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