Compliance Manager

Cencora

5d•Onsite

About The Position

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! This position is located onsite at our facility in Brooks, KY. There is no option for remote or hybrid work. This role is in support of Cencora's third party logistics service in the US operating through our ICS business. 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.

Requirements

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

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.
Performs related duties as assigned.