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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management within regulated life sciences environments, focusing on supplier quality oversight, compliance with GCP, GLP, GMP, and GDP regulations, and effective project management across global, cross-functional teams.
Highest-signal resume keywords
Supplier Quality ManagementGCP, GLP, GMP, GDP RegulationsQuality Agreements DevelopmentProject ManagementCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality ManagementSupplier Quality OversightGMP ComplianceGDP ComplianceQuality KPIs DefinitionRisk-Based TriageContinuous Improvement InitiativesContract NegotiationTransactional LeanValue Stream Mapping
Soft Skills
LeadershipNegotiationCritical ThinkingAnalytical SkillsEffective Communication
Tools & Technologies
Supplier Quality Management Systems
Industry Keywords
Life SciencesClinical DevelopmentGlobal Matrix OrganizationCross-Functional TeamsQuality Governance
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide risk-based Quality governance and oversight for R&D suppliers
- Support and facilitate a cross-functional R&D and Operations forum for clinical quality issues
- Coordinate intake and risk-based triage of complex clinical supplier and Quality issues
- Identify applicable requirements, potential Quality and business risks, subject matter experts, and accountable functions
- Partner with Quality and business stakeholders to establish supplier qualification and oversight strategies
- Support development, negotiation, and maintenance of Quality Agreements and supplier Quality requirements
- Collaborate with research and other functions on continuous improvement initiatives
- Act as Quality lead for quality records related to R&D Supplier management
- Define and maintain R&D Supplier Quality KPIs and metrics
- Drive escalation, documentation, and continuous improvement for supplier-quality risks
- Coordinate across multiple functions and time zones in a global, matrixed organization
Requirements
What you’ll need- Doctorate degree and 2 years of Quality Management or other relevant experience OR Master’s degree and 4 years OR Bachelor’s degree and 6 years OR Associate’s degree and 10 years OR high school diploma/GED and 12 years
- Experience in supplier quality management or oversight
- Working knowledge of GCP, GLP, GPvP, GMP, and GDP regulations, practices, and trends
- Experience in clinical supply chain Quality or oversight of GMP/GDP-regulated services used in clinical development
- Practical experience applying GMP and/or GDP requirements within a regulated life sciences environment
- Ability to influence and drive progress across functions
- Effective decision-making and influencing skills
- Strong leadership, negotiation, critical thinking, and analytical skills
- Written and verbal communication skills
- Ability to use tools and systems supporting supplier quality management processes
- Excellent project management abilities
- Experience in a global, matrix organization across multiple time zones
- Experience supporting supplier quality oversight across complex, cross-functional, or global environments
- Experience in contract negotiations and supplier/service-provider relationship building
- Experience in transactional lean and value stream mapping
- Ability to adapt to changing business needs and navigate ambiguity
- Willingness and capability to travel up to 15%
- Sponsorship is not guaranteed
Benefits
Comp & perks- Health and welfare plans for staff and eligible dependents
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Financial plans with opportunities to save towards retirement or other goals
- Work/life balance