Barden are delighted to be supporting our renowned biotechnology client that specializes in the research, development, and commercialization of innovative therapies in the field of life sciences in their search for a Director Vendor Management Quality
As Director, Vendor Quality Management, you will be responsible for providing quality advice, direction, and leadership for quality and compliance oversight of GxP vendors. You will work closely with external quality groups to ensure vendor commitments & services meet standards and comply with regulations.
You will serve as the R&D Quality Business Partner for specific groups, offering strategic guidance on R&D quality, risk management, and continuous improvement that affects Good Practices (GxP) across functions. Your role involves advising on GxP risk reduction, helping partners understand risks and solutions, and taking the lead in addressing quality issues. Additionally, you will play an active role in Quality forums, cross-functional teams, and projects.
Roles & Responsibilities:
- Oversees comprehensive vendor quality oversight program which includes vendor risk assessments, Quality Issue Management and governance for GxP vendors.
- Lead quality participation in vendor qualification, selection, requalification and governance activities.
- Lead and support development and ongoing management of Quality Agreements with key vendors
- Interfaces with key internal business stakeholders and external groups including Vendors and Contract Research Organizations (CROs) Quality organizations.
- Develops strong relationships with key vendors, creating a mindset of partnership and mutual respect.
- Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical
- Governance on internal quality audits, regulatory agency inspections, risk assessments, deviations and CAPAs for vendor related activities.
- Serves as an expert and provide guidance on and interpretation of GxP regulations, standards, and quality systems for internal stakeholders.
- Assists in inspection readiness and preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings, as applicable.
- Supports deviation identification, reporting, and CAPA development, as applicable.
- Oversees effective vendor quality reporting to functional management and the Senior Leadership team. This includes presenting relevant vendor metrics, trends and quality risks at quality meetings & governance forums.
- As an expert, provide sound judgment and risk-based rationale to facilitate decision-making and support the development and execution of effective and comprehensive action plans to address quality and compliance risks.
- Leads Quality-to-Quality (Q2Q) governance meetings and represents R&D Q&MG in Operational
- Reviews vendor contractual language from a quality & compliance perspective
ABOUT THE PERSON:
- Bachelor’s degree with significant years; Master’s degree with 10+ years of R&D quality assurance compliance experience in a highly regulated environment.
- Must have GCP/GCLP/GVP audit and compliance experience.
- Proven experience in managing vendor quality programs and/or vendor relationship management.
- Has effectively operated within Clinical Quality Assurance or similar function in a Biopharma sponsor organization.
- Strong organizational & project management skills including the ability to prioritize and adapt to business needs while upholding compliance with regulations and company procedures.
For more information contact Aidan Crowley on email@example.com
Candidates must be an EU Citizen or hold a valid work permit/visa to be considered.
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