Quality and Regulatory Manager
Quality and Regulatory Manager
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Salary Not Disclosed
1 Vacancy
Job Description
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!
Job Details
Location: Onsite in Grand Prairie TX
- There is no option for remote or hybrid work.
Typical Work Hours: 8:00am 5:00pm Monday-Friday
This role is supporting our AmerisourceBergen business which offers supply chain services to healthcare providers and health systems in the United States.
The Quality and Regulatory Manager is 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.
Responsible for the maintenance execution and monitoring of the BU Locations 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 .
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 facilitys 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.
Education:
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 bachelors degree program or equivalent combination of experience and education; normally requires a minimum of four (4) years directly related and progressively responsible experience.
Skills and Abilities:
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 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 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 time 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 companys 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 . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returnedEqual Employment Opportunity
Affiliated Companies
Affiliated Companies: AmerisourceBergen Services Corporation
Required Experience:
Manager
Employment Type
Full-Time
