Quality and Regulatory Manager Job at Cencora (Cincinnati)

Job Description

This role is supporting our AmerisourceBergen business, which offers supply chain services to healthcare providers and health systems in the United States. Under general supervision of the Regional Director, Quality and Regulatory Operations (QRO) with a dotted line to the Regional Director of Quality Assurance, responsible for assuring the business unit (BU) location maintains a robust, effective Quality Management System and security & regulatory compliance effort that aligns with Cencora' s policy and procedures, as well as state and federal regulations. This position will ensure compliance with the principles of Good Distribution Practices (GDP) and will have the authority and responsibility for ensuring the quality system is in a state of compliance and will facilitate knowledge transfer throughout the operation to help build a Quality and Regulatory Compliance Culture.

Job Responsibility

Assuring the business unit (BU) location maintains a robust, effective Quality Management System and security & regulatory compliance effort that aligns with Cencora's policy and procedures, as well as state and federal regulations
Ensure compliance with the principles of Good Distribution Practices (GDP)
Facilitate knowledge transfer throughout the operation to help build a Quality and Regulatory Compliance Culture
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
Responsible for collaborating with BU location on implementation of annual Quality Objectives 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
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
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
Reviews and verifies that all controlled substance and listed chemical inventories 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

Requirements

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

What we offer

Medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families which may include backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions
paid parental leave
paid caregiver leave
variety of training programs
professional development resources
opportunities to participate in mentorship programs
employee resource groups
volunteer activities

Cencora - All Job Offers

Select Country

Quality and Regulatory Manager

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?

Quality and Regulatory Manager

Quality, Regulatory and Sustainability Manager

Senior Manager Quality Assurance: Incoming Quality and Warehouse

Compliance and Quality Manager

Medical Device Regulatory and Quality Consultant

Technical and Quality Manager (Polymers)

Technical and Quality Manager (Polymers)

Technical and Quality Manager

Director of Quality and Regulatory Affairs

Our AI answers in your language