Sr Director - Quality Management Systems

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 resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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