Cencora · 2 days ago
Quality and Regulatory Manager
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
4+ years expCencora is an innovative company dedicated to creating healthier futures. They are seeking a Quality and Regulatory Manager to maintain an effective Quality Management System and ensure compliance with state and federal regulations, while promoting a culture of quality across the business unit.
Emergency MedicineEnterprise SoftwareHealth CareMedicalPharmaceutical
Responsibilities
Responsible for the maintenance, execution, and monitoring of the BU Location’s Quality Management System (QMS), Good Distribution Practices (GDP), and compliance with all local state (BOP, DOH, etc.),, and federal regulations (DEA, EPA, FDA, OSHA, etc.) as well as all corporate policies and procedures
Monitors, verifies, and maintains all BU location local, state, and federal licensure and registrations as required
Acts as primary liaison between BU location and all local, state, and federal regulatory agencies. Manages and/or assists with all inspections, investigations, and information requests
Conducts required Quality, Health & Safety, Security and Regulatory Assessments
Promotes a culture of Quality across the BU location that ensures management commitment and understanding of USP 1079 (GDP), good documentation practices, Data Integrity, and Good Storage, Distribution and Transportation practices
Responsible for collaborating with BU location on implementation of annual Quality Objectives (e.g., Right the First Time, Mistake-Proofing, DSCSA compliance) and Key Business Drivers established for DC operations
Responsible for supporting and monitoring BU location Quality, Health & Safety, Security and Regulatory training
Supports development of BU location QMS components e.g. RCA investigation, CAPA identification, and implementation, change control process, risk management, cGMP refresher training
Utilize metrics and trend analysis to effectively monitor processes, report on performance, drive improvement and provide cost savings to the BU location
Collaborate with Transportation on carrier-related issues where root cause analysis and corrective actions are initiated to improve carrier performance
Generate monthly and quarterly metric reports for regional leadership review. Attend and participate in Regional Quality metric calls/meetings. Represent Quality and Regulatory as a member of the BU location leadership team and Monitors and ensures compliance with corporate policy related to all temperature and security monitoring and alarm systems, access cards, key control, CCTV
Manages and maintains all DC Power of Attorney documentation for all signers of Schedule 2 order forms
Reviews Schedule 2 order forms (DEA Form 222s) to ensure compliance of Schedule 2 transactions
Monitors the AB Order Monitoring Program (OMP) at the BU location level to ensure compliance with all corporate, state, and DEA requirements
Reviews and verifies that all controlled substance and listed chemical inventories (daily counts, monthly, annual & biennial) are completed and maintained as per corporate policy
Ensures BU location investigates all significant inventory variances, thefts and losses
Ensures all ARCOS and state reporting requirements and submissions are completed per corporate, state, and federal requirements
Maintains and manages notification and submittal of all correspondence to state and federal agencies regarding losses of Rx, Controlled Substance, and/or Listed Chemical product as per corporate policy
Ensures BU location reports Suspect Product notifications to Product Integrity and assists with Suspect Product investigations
Manages and oversees all aspects of the facility’s Health & Safety Program (H&SP)
Responsible for heightening the awareness of security issues and bringing potential diversion activities and security breaches to the attention of CSRA Leadership; identifies areas of vulnerability and propose reconciliation procedures; takes prompt corrective action when unsafe acts or conditions are observed
Willingness to travel up to 10%
Performs related duties as assigned
Qualification
Required
Requires broad training in fields such as Life Science or related field, business administration, or similar vocations generally obtained through completion of a four-year bachelor's degree program or equivalent combination of experience and education; normally requires a minimum of four (4) years directly related and progressively responsible experience
Process-oriented, Continuous Improvement experience such as Lean Six Sigma
Good understanding of local, state, and federal laws and regulations and knowledge of the agencies that regulate the BU location
Detailed understanding of all drug distribution practices and procedures
Ability to communicate effectively both orally and in writing
Effective presentation and training skills
Strong interpersonal skills
Strong leadership skills
Effective negotiation skills
Strong organizational skills; attention to detail
Good analytical skills; self-motivating
Ability to follow and interpret government regulatory requirements and changes
Ability to implement processes resulting in satisfactory audit practices
Strong decision-making skills
Excellent problem-solving skills; ability to resolve issues effectively and efficiently
Advanced skills in Microsoft Office Suite
Benefits
Medical, dental, and vision care
Backup dependent care
Adoption assistance
Infertility coverage
Family building support
Behavioral health solutions
Paid parental leave
Paid caregiver leave
Training programs
Professional development resources
Opportunities to participate in mentorship programs
Employee resource groups
Volunteer activities
Company
Cencora
Cencora is a global healthcare company that advances the development and delivery of pharmaceuticals and healthcare products.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$4.83B2024-12-02Post Ipo Debt· $1.8B
2024-02-05Post Ipo Debt· $500M
2022-11-07Post Ipo Secondary· $500M
Leadership Team
Robert Mauch
President and Chief Executive Officer
Mike Baca
Senior Director, AI Platforms & Solutions
Recent News
legacy.thefly.com
2026-02-04
2026-02-04
Benzinga.com
2026-02-04
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