Quality Sr. Specialist, Vendor Management (contract) 25416
Quality Sr. Specialist, Vendor Management (contract) 25416
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Job Description
Job Description
The Senior Quality Specialist Vendor Management works with a high degree of independence and is adept at troubleshooting problems to create and execute improved internal procedures and to ensure compliance with applicable regulatory requirements. The Senior Quality Specialist completes work in a resourceful selfsufficient manner and is able to design alternative approaches to achieve desired outcomes. This role is responsible for providing coordination and support of Vendor Management processes within CMC Quality.
This position reports to: Director Small Molecule CMC ComplianceVendor Quality Management
REQUIRED KNOWLEDGE SKILLS AND COMPETENCIES:
Key Leadership Skills:
- Crossfunctional collaboration
- Results driver
Key Knowledge/ Skills and Competencies:
- GxP knowledge with global understanding /application of phase appropriate regulations
- Working knowledge of:
- Compliance GMP/GDP regulationsapplicable global regulations for modalities such as medical device solid oral dose biologic gene therapy etc.
- Phase appropriate requirements (based on product lifecycle)
- Materials Vendor and Audit Management processes
- Quality Management Systems and associated information systems (software/systems)
- Technical writing
- Attention to detail
- Communication and Relationship management skills
- Flexibility/adaptability
- Analytical thinking
- Continuous improvement
- Veeva experience
KEY RESPONSIBILITIES:
- Ensures that the Approved Vendor Lists are kept current and that the information within is accurate.
- Oversee Quality and Compliance of Vendor Profile Records across GDP and GMP vendors.
- Partner with internal customers (AIM business stakeholders and Operational QA).
- Update Vendor Profiles as needed.
- Monitor and facilitate changes with External Partners.
- Ensures that all the documentation associated to the Vendor Management program; risk assessment reports Approved Vendor Lists Vendor Profile Records contact lists GMP certificates supporting documentation etc. is uploaded into the applicable QMS and documentation repositories as applicable.
- Supports metrics activities for the Vendor Management program.
- Consults with other QA functions team members and Supply Chain stakeholders to complete the Supply Chain Maps; ensure that the AVL is keep updated and aligned with the Supply Chain Maps.
- Verifies vendor addresses to ensure the Approved Vendor List (AVL) is accurate to support regulatory submission activities.
- Ensures vendor Scorecards are completed and up to date.
- Coordinates ongoing meetings with customers to collect performance feedback and ensure the completion on time of the Vendors performance dashboard.
- Coordinate Vendor Change Notification (VCN)meetings and initiate Change Requests in VeeQMS.
- Monitor the Vendor Management centralized eMail inbox for VCN
- Create Change Request in VeeQMS
- Escalate issues if
- Provide support for Change Management related to Vendor Quality Management.
- Provide support for Deviations and CAPA activities related to Vendor Quality Management.
- Ensures that the SOPs SDs and WI associated to the Vendor Management Program are current.
- Identifies risks and communicates gaps to applicable Quality System Owner(s).
- Serves as a liason between the business Sourcing groups and QA functions for the selection onboarding and monitoring of vendors.
- Assist with authoring of Risk Assessment and Mitigation plans for High Risk and Restricted Vendors.
- Serve as a liaison for communication Vendor Excipient Risk Assessment and Reduced Review Process.
- Develops and implement initiatives to improve the Quality Agreement and Vendor Management processes.
- Other tasks as assigned by Management.
PREFERRED QUALIFICATIONS:
- M.S. (or equivalent degree) and 0 3 years of relevant work experience or B.S. in a scientific or allied health field (or equivalent degree) and 5 8 years of relevant work experience or relevant comparable background
- Experience with Vendor /Audit management in the GxP space
- Experience participating on crossfunctional teams
- Experience using computerized systems such as EDMS EQMS and ELMS.
- Proficiency in using Microsoft Office applications required (MS Word MS Excel MS Powerpoint)
Pay Range
$55$65/hr
Requisition Disclaimer
This job posting is for a temporary role with a thirdparty 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 thirdparty 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 jobrelated 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 ThirdParty Vendors
Required Experience:
Senior IC
Employment Type
Full-Time
