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Job Details

The Senior Director will be responsible for the US Supply Chain (USSC) Quality Management System (QMS.) Responsibilities include but not limited to adoption and sustainment of all relevant quality standards for a pharmaceutical wholesale distributor operating the United States.

Remote position

• Owner of US Supply Chain (USSC) Quality Management System including overall strategy for Quality Plan, documentation, Corrective and Preventative Actions (CAPAs), Change Controls, Complaints Management, etc.
• Establishes metrics and key performance indicators (KPIs) for USSC’s Quality Management System.
• Leads implementation of electronic Quality Management System (eQMS) for USSC partnering with Global Quality and Regulatory Assurance (GQRA), Legal, Environmental Health and Safety, and complimentary Business Units (BUs.)
• Facilitates Management Review at appropriate frequency to provide Cencora and USSC senior leadership with an overview of the health of the USSC QMS.
• Forward facing resource for all interactions with US Food and Drug Administration (FDA) and State Boards of Pharmacy (BOP) on all quality related matters.
• Responsible for the iterative adoption of USSC’s ‘Culture of Quality’ initiative driving quality principles to all corners of USSC.
• Routinely interacts with USSC operational and functional leadership teams to identify opportunities for further adherence and integration of Quality standards.
• Chair, Product Review Board (PRB), ensuring that all products subject to quality events, excursions, etc. are thoughtfully reviewed for viability.
• Drives standardization of adherence to processes across all regions and functions to ensure a USSC wide approach to Quality.
• Reviews and approves network wide responses to audit findings, Facility Inspection Readiness Tool (FIRT) assessments, and Self-Assessments.
• Provides direction in response to government, supplier, customer, and internal audits in compliance with Cencora Policies and Procedures.
• Partners with key stakeholders including but not limited to Global Quality and Regulatory Assurance (GQRA), Legal, Environment Health and Safety (EHS), USSC Operations, Transportation, US Pharmaceutical and Animal Health (USPAH), Strategic Global Sourcing (SGS) to provide key quality insights in process development and execution.
• Monitors and implements evolving Quality requirements set forth by regulators, manufacturers, customers, etc.
• Provides support for network wide quality and continuity events. 

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• Minimum 15 years of experience in Life Science Quality
• Highly preferred, minimum 5 years’ experience in Pharmaceutical Wholesale Distribution
• Requires broad training in related field through completion of a four-year bachelor’s degree program or equivalent combination of education and experience.
• Successful implementation of a QMS in a large matrixed organization 
• Successful implementation of an eQMS from requirements gathering through business process integration and deployment.
• Leadership in industry forums, regulator interaction.
• Prior experience leading and facilitating regulatory body audits
• Demonstrated ability to work vertically and horizontally to achieve a collaborative result.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Excellent communication both orally and in writing
• Strong leadership skills
• Ability to work in a highly matrixed environment.
• Excellent logical, analytical reasoning, and problem-solving skills to evaluate business problems and apply knowledge to identify appropriate solutions; ability to resolve associate issues effectively and efficiently.
• Strong project management acumen
• Excellent organizational, motivational, and interpersonal skills
• Utilization of multiple electronic Quality Management Systems (eQMS)
• Proficiency in Quality Standards including ISO 9001, CFR 205.50, etc.
• Working knowledge of Drug Supply Chain Security Act, Food Safety Modernization Act, and Modernization of Cosmetics Regulation Act
• Aptitude for translating quality standards into business processes.

What Cencora offers

We provide compensation, benefits, and re