Senior R&D Supplier Quality Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver risk-focused Quality governance and oversight for R&D suppliers.

• Facilitate a collaborative forum across R&D and Operations to address clinical quality concerns.

• Manage the intake process and prioritize complex clinical supplier and Quality issues based on risk.

• Determine relevant requirements, potential Quality and business risks, subject matter experts, and responsible functions.

• Collaborate with Quality and business stakeholders to develop strategies for supplier qualification and oversight.

• Assist in the creation, negotiation, and maintenance of Quality Agreements and supplier Quality requirements.

• Work alongside research and other departments to drive continuous improvement initiatives.

• Serve as the Quality lead for managing quality records associated with R&D Supplier management.

• Establish and uphold R&D Supplier Quality KPIs and metrics.

• Promote escalation, documentation, and ongoing enhancement for supplier-quality risks.

• Coordinate efforts across multiple functions and time zones within a global, matrixed organization.

⛳️ Requirements

• Doctorate degree with 2 years of Quality Management or relevant experience OR Master’s degree with 4 years OR Bachelor’s degree with 6 years OR Associate’s degree with 10 years OR high school diploma/GED with 12 years.

• Proven experience in supplier quality management or oversight.

• Familiarity with GCP, GLP, GPvP, GMP, and GDP regulations, practices, and trends.

• Experience in clinical supply chain Quality or oversight of GMP/GDP-regulated services utilized in clinical development.

• Practical experience in implementing GMP and/or GDP requirements in a regulated life sciences setting.

• Capability to influence and propel progress across different functions.

• Strong decision-making and influencing abilities.

• Excellent leadership, negotiation, critical thinking, and analytical skills.

• Proficient written and verbal communication skills.

• Ability to utilize tools and systems that support supplier quality management processes.

• Exceptional project management skills.

• Experience in a global, matrix organization across various time zones.

• Background in supporting supplier quality oversight within complex, cross-functional, or global environments.

• Experience in contract negotiations and fostering supplier/service-provider relationships.

• Knowledge in transactional lean and value stream mapping.

• Ability to adjust to evolving business needs and navigate through ambiguity.

• Willingness and ability to travel up to 15%.

• Sponsorship is not guaranteed.

🏝️ Benefits

• Health and welfare plans available for staff and their eligible dependents.

• Retirement and Savings Plan featuring generous contributions from the company.

• Comprehensive group medical, dental, and vision coverage.

• Life and disability insurance provided.

• Flexible spending accounts offered.

• Discretionary annual bonus program available.

• Stock-based long-term incentives included.

• Award-winning time-off plans in place.

• Flexible work models available where feasible.

• Opportunities for career development.

• Financial plans with options to save for retirement or other objectives.

• Support for work/life balance initiatives.