Senior Quality Specialist- Vendor Management
Boston, MA Posted: 1/24/2020
A leading biopharmaceutical company has an opening for a Senior Quality Specialist-Vendor Management QA
TITLE/ROLE: Senior QualitySpecialist AREA: Vendor Management QA
GENERAL POSITION SUMMARY:
The Senior Quality Specialist 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, self-sufficient 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 the GCP/GMP/GDP/GVP space.
This position reports to: Director, Vendor Quality Management
REQUIRED KNOWLEDGE, SKILLS AND COMPETENCIES:
Key Leadership Skills:
- Cross-functional collaboration
- Results driver
Key Knowledge/ Skills and Competencies:
- GxP knowledge with global understanding / application of phase appropriate regulations
- Awareness of:
- Compliance GCP/GMP/GDP/GVP regulations- applicable global regulations for modalities such as medical device, solid oral dose, biologic, gene therapy, etc.
- 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
- Negotiation/Influencing skills
- Risk-based/critical thinking
- Analytical thinking
- Continuous improvement
- Ensures that the AVL’s are kept current and that the information within is accurate.
- 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.
- Coordinates ongoing meetings with customers to collect performance feedback and ensure the completion on time of the Vendor’s performance dashboard.
- Ensures that the SOPs, SD’s and WI associated to the Vendor Management Program are current.
- Identifies risks and communicates gaps to applicable Quality System Owner(s).
- Verifies vendor addresses to ensure the Approved Vendor List (AVL) is accurate to support regulatory submission activities and accurately reflects where activities are performed.
- Consults with other QA functions team members and Supply Chain stakeholders to complete the Supply Chain Maps; ensure that the AVL is updated and aligned with the Supply Chain Maps.
- Serves as a liaison among the business, Sourcing groups and QA functions for the selection, onboarding and monitoring of vendors.
- Contributes to and supports initiatives to improve the Quality Agreement and Vendor Management processes.
- Other tasks as assigned by Management.
EDUCATION AND EXPERIENCE:
- 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 cross-functional teams
- Experience using computerized systems such as EDMS, EQMS, ELMS and SharePoint
- Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS Powerpoint)
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