Senior Director, Supplier Quality

AMER•Fishers, IN

10d•Remote

About The Position

The Sr Director of Supplier Quality leads the global strategy, governance, and performance management of the supplier quality program. This role ensures that all external suppliers, CMOs, and contract laboratories meet regulatory, quality, and business requirements to enable uninterrupted supply of GMP/GDP materials, components, intermediates, and finished products. The Sr Director of Supplier Quality will demonstrate core strengths in supplier evaluation and selection, monitoring and development. This includes a robust process of working with key business partners and intelligently selecting suppliers based on fit for purpose criteria. The criteria will include measurements of competencies in quality assurance and control, risk management, continuous improvement, collaboration, and communication. The Sr Director will guide the design and maturity of audit programs and will provide leadership in managing supplier audits, and inspections, with a strong understanding of regulations from the major health authorities and associations. As a key member of our corporate quality leadership team, this individual will play a crucial role in ensuring the ongoing compliance, quality standards, and inspection readiness of our GxP suppliers as well as our internal sites and external partners. This role is fully remote with about 30% travel required, including some international travel.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or a related discipline, an advanced degree is preferred
15+ years of experience in GMP operations, within the pharmaceutical or biotech industry
7+ years of leading global teams in the pharmaceutical or biotechnology industry
10+ years in GMP supplier quality, external manufacturing, material quality, or technical quality leadership.
Proven track record leading global teams and scaling global supplier quality programs
Strong knowledge of GxP regulations
Skilled at leading teams through ambiguity and driving decisive action.
Strong collaboration with Procurement, Operations, Technical Services, Regulatory, and Supply Chain.
Proven leadership experience in managing cross-functional teams in a quality-related environment as well as managing strategic partner accountabilities from a supplier quality perspective
Excellent communication and interpersonal skills
Strong analytical and problem-solving abilities
Ability and willingness to travel as needed

Responsibilities

Global Supplier Quality Strategy & Leadership Shape the global supplier quality strategy to align with corporate and quality objectives.
Develop and maintain governance models and performance frameworks for supplier oversight across all regions.
Lead and develop a high-performing, geographically dispersed supplier quality team.
Define expectations and guidelines for conducting Person in Plant requirements based on data and risk Supplier Qualification & Lifecycle Management
Oversee processes for tracking, monitoring, and communicating supplier-related risks to Quality, Compliance, and Global Influence functional organizations to recognize and address systemic quality issues at external sites and with strategic partners to drive improvements, mitigating risk, and support better inspection outcomes
Ensure risk-based qualification aligned with ICH Q9, ICH Q10, and applicable GMP requirements.
Guide and development of supplier risk scoring and segmentation to prioritize oversight and audits.
Supplier Audits & Compliance Oversight Provide strategic oversight of global audit planning, execution, and follow-up for suppliers, CMOs, and contract labs.
Ensure audit observations are addressed effectively, with timely CAPA closure and robust effectiveness checks.
Maintain audit programs consistent with FDA, EMA, MHRA, TGA, PMDA, Health Canada, and other health authority expectations.
Issue Management & Quality Escalation Lead response and escalation processes for supplier deviations, OOS, critical defects, and supply-related disruptions.
Serve as key decision-maker and escalation point within cross-functional supplier crisis management.
Partner with Procurement, Operations, and Technical teams to resolve supplier quality issues and drive continuous improvement.
Continuous Improvement Oversee the ongoing optimization within Master Control Supplier Quality and where applicable Audit Module and the ongoing maintenance of program outputs for Supplier Quality
Create a living Quality Transformation plan around Supplier Quality Initiatives with both internal and external actions
Drive implementation of digital tools for supplier monitoring (e.g., eQMS modules, audit management, scorecards).
Implement industry best practices for advanced quality analytics, predictive risk modeling, and supplier quality modernization.
Collaboration and Communication Coordinate with Manufacturing and other key business partners to maintain a lifecycle approach to supplier and strategic partner relationships
Lead the management of the master supplier list for the entire company Leads cross functional teams in Quality improvement initiatives