Senior Quality Specialist, Clinical Distribution (Contract) 27806
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Job Location:
Boston, NH - USA
Monthly Salary:
$ 55 - 65
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description
Vertex Pharmaceuticas is seeking a highly motivated and experienced Senior Quality Specialist to serve as a key subject matter expert in Good Distribution Practice (GDP) for our global clinical supply chain. The ideal candidate wil have expertise in GDP envrinoment with vendor managment documentation quality events temperatur excursion and reporting metrixs.
Key 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 Affair
1. Clinical GDP Oversight & Compliance:
- 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
2. Vendor Management and Internal Partner Support
- Vendor
- 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
- Internal Partners
- Provide support on programs phases 1 to 3 across modalities globally
- Attend program meetings provide functional updates
2. Quality Event & Deviation Management:
- Support quality event investigations (root cause analysis product impact CAPA effectiveness and disposition) including temperature excursions
- Support change management
- Metrics Reporting & Continuous Improvement:
- Maintain KPIs for clinical GDP performance
- Analyse trends to proactively identify risks and drive continuous improvement initiatives
- Prepare and present quality metrics and updates
Qualifications & Experience
- Bachelors 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
Pay Range
$55-$65/hr
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements
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No C2C or Third-Party Vendors
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
