Vendor Quality Management, Senior Specialist (Contractor) 23027
Job Description:
The Sr. Specialist is responsible for providing coordination and support of Vendor Quality Management processes within CMC Quality. This role works with a high degree of independence to ensure compliance to Vertex vendor quality processes and governance and regulatory expectations and supports QA operational quality oversight and management of Vertex Vendors.The Sr. Specialist is adept at troubleshooting problems to create and execute improved internal procedures, and completes work in a resourceful, self-sufficient manner and is able to design alternative approaches to achieve desired outcomes.
The ideal candiate with have experience working with vendor/suppliers in a quality setting, Audit managment experience and great written/verbal communication. Experience with VQMS is perferred.
This position reports to: Associate Director, Small Molecule CMC Compliance – Vendor Quality Management
Key Leadership Skills:
- Demonstrated ability to work and collaborate across functions
- Results-driven, with demonstrated ability guide individuals/teams toward desired outcome
- Strong communication and relationship management skills
Key Knowledge/Skills and Competencies:
- GxP knowledge with global understanding /application of phase appropriate regulations
- Working knowledge of the following:
- Compliance of GMP/GDP regulations-applicable global regulations for modalities such as solid oral dose, biologic, medical device, gene therapy, etc.
- Phase appropriate requirements (based on product lifecycle)
- Vendor and Audit Management processes
- Quality Management Systems and associated information systems (e.g., Veeva)
- Technical writing
- Attention to detail
- Communication and relationship management skills
- Flexibility/adaptability
- Analytical/critical thinking
- Continuous improvement / process optimization
Key Responsibilities:
Vendor Quality Management- Support Vendor Quality Management Roadmap initiatives, including initiatives to improve the Quality Agreement and other Vendor Management processes, as applicable
- Provide vendor management support in the qualification/requalification of Vertex vendors
- Identifies risk and communicates gaps to applicable Quality System Owners
- Assist with development of risk assessments and mitigation plans for applicable Vertex vendors
- Provide support for Deviations and CAPA activities related to Vendor Quality Management
- Supports document lifecycle activities associated with Vendor Management SOPs and/or work-instructions
- Supports collection and reporting of Vendor Quality Management System metrics
- Serve as a liaison between the Business, Strategic Sourcing, and QA functions for the selection, onboarding, and monitoring of vendors
- Provide vendor management support in the qualification/requalification of Vertex vendors
- Supports maintenance of Vertex Approved Vendor Lists by ensuring vendor data is current/accurate.
- Supports maintenance of Vertex Supplier Files by ensuring that all Vendor documentation (e.g., Vendor Profile Records, GMP certificates, risk assessments) are current/accurate and uploaded into the applicable QMS or quality document repositories, as applicable.
- Collaborate with applicable stakeholders (e.g., Audit and Inspection Management, Operational QA, and business stakeholders, etc.) to drive the development and maintenance of Vendor Profile Records (VPR) across GMP and GDP vendors.
- Support completeness and accuracy verification of Vendor information on Vertex Supply Chain Maps
- Supports development, maintenance, and continuous improvement of Vendor Scorecard process
- Coordinate and/or facilitate meetings with customers to collect vendor performance feedback and ensure timely completion of Vendor’s performance dashboard
- M.S. (or equivalent degree) and 0-3 years of relevant work experience, or B.S. in a scientific or allied health field and 4+ years of relevant work experience, or relevant comparable background
- Experience with Vendor/Audit management in the GxP space
- Experience participating on cross-functional teams
- Experience using computerized systems including Electronic Document Management (eDMS), Electronic Quality Management System (eQMS) and Electronic Learning Management (eLMS)
- Proficiency in using MS Office applications required (including MS Word, MS Excel, PowerPoint)
Pay Range:
$55-63/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 law.
In 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