Senior Director – Quality and Regulatory Operations
AmerisourceBergenAbout the role
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
What you will be doing
Under general direction of the Vice President, Quality and Regulatory Operations (QRO), responsible for day-to-day regional Quality and Regulatory Operations for the US Supply Chain. Responsibilities include but not limited to compliance with all FDA, DEA, Boards of Pharmacy, Department of Health, OSHA, Department of Agriculture etc. requirements. Responsible for the direct supervision of six (6) Regional QRO Directors.
- Directs the activities of the QRO Regional Directors (6) and their assigned distribution centers (42); provides guidance as it relates to job duties and responsibilities.
- Provides leadership and oversight to regional QRO teams to support the deployment of any process or operational updates.
- Routinely interact with regional Operational leadership teams to identify opportunities for additional QRO support and alignment.
- Routinely review processes with regional teams to identify best practices.
- Engages with regional leadership, HR, finance, and Sr. Leaders to align on long term labor requirements and staffing strategy.
- Drives standardization of adherence to processes across all regions to ensure a USSC wide approach to Quality and Regulatory compliance.
- Ensures that all Distribution Centers are in compliance with the Cencora Diversion Control Program.
- Responsible for QRO organizational adherence to training deadlines and requirements.
- Reviews and approves network wide responses to audit findings, Facility Inspection Readiness Tool (FIRT) assessments, and Self-Assessments.
- Provides direction in response to government and non-government audits in compliance with Cencora Policies and Procedures.
- Partners with relevant stakeholders to deploy Quality Management System (QMS) infrastructure for USSC including Corrective and Preventive Actions (CAPAs), Deviations, Complaint Management, Change Controls.
- Supports development and maintenance of USSC 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 regulatory and quality insights in process development and execution.
- Responsible for all team member relations functions for assigned lead team including hiring, terminating, performance management, development, and training.
- Provides compliance support for network wide continuity events.
What your background should look like
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
Requires broad training in related field through completion of a four-year bachelor’s degree program or equivalent combination of education and experience.
Successful execution of projects and programs in a large matrixed organization
Prior experience leading and facilitating regulatory body audits
Successful track record of compliance
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 proje
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