Quality Assurance Manager

Cencora•Shakopee, MN

22d•Onsite

About The Position

The Quality Assurance Manager supports Cencora’s MWI Animal Health business at its Shakopee, Minnesota facility. Under the general supervision of the Regional Director, Quality and Regulatory Operations, with a dotted-line relationship to the Regional Director of Quality Assurance, this role ensures that the business unit location maintains an effective Quality Management System and meets applicable security, regulatory, and corporate requirements. The manager is responsible for maintaining and monitoring the location’s QMS and Good Distribution Practices, promoting a culture of quality and regulatory compliance, and supporting knowledge transfer throughout the operation. The position oversees compliance with local, state, and federal regulations and corporate policies, including licensing, regulatory agency interactions, inspections, investigations, controlled-substance processes, security monitoring, and facility health and safety. It also supports quality objectives, training, corrective and preventive actions, risk management, continuous improvement, and performance reporting. The role is onsite in Shakopee, Monday through Friday, generally 8:00 a.m. to 4:30 p.m.; schedule flexibility may be needed based on business needs. Travel of up to 10% is expected.

Requirements

A four-year bachelor’s degree in Life Science, business administration, a related field, or an equivalent combination of education and experience.
A minimum of four years of directly related, progressively responsible experience.
Process-oriented approach and continuous improvement experience, such as Lean Six Sigma.
Good understanding of applicable local, state, and federal laws and regulations and the agencies that regulate the business unit location.
Detailed understanding of drug distribution practices and procedures.
Ability to communicate effectively orally and in writing.
Effective presentation and training skills.
Strong interpersonal, leadership, and negotiation skills.
Strong organizational skills and attention to detail.
Good analytical skills and self-motivation.
Ability to follow and interpret government regulatory requirements and changes.
Ability to implement processes that result in satisfactory audit practices.
Strong decision-making and problem-solving skills, including the ability to resolve issues effectively and efficiently.
Advanced skills in Microsoft Office Suite.
Willingness to travel up to 10%.
Flexibility to work different hours or days based on business needs.

Responsibilities

Maintain, execute, and monitor the business unit location’s Quality Management System and Good Distribution Practices, ensuring compliance with local, state, and federal regulations and corporate policies.
Monitor, verify, and maintain required local, state, and federal licenses and registrations.
Serve as the primary liaison between the business unit location and local, state, and federal regulatory agencies.
Manage or assist with inspections, investigations, and regulatory information requests.
Conduct required Quality, Health & Safety, Security, and Regulatory assessments.
Promote understanding of USP 1079, good documentation practices, data integrity, and good storage, distribution, and transportation practices.
Collaborate with the business unit on annual quality objectives and key business drivers for distribution center operations.
Support and monitor quality, health and safety, security, and regulatory training.
Support development of QMS components, including root-cause investigations, CAPA identification and implementation, change control, risk management, and cGMP refresher training.
Use metrics and trend analysis to monitor processes, report performance, drive improvement, and identify cost savings.
Collaborate with Transportation on carrier-related issues, root-cause analysis, and corrective actions.
Generate monthly and quarterly metric reports for regional leadership and participate in regional quality metric meetings.
Represent Quality and Regulatory on the business unit location leadership team.
Monitor compliance with corporate policies for temperature and security monitoring and alarm systems, access cards, key control, and CCTV.
Manage and maintain DC Power of Attorney documentation for Schedule 2 order-form signers and review DEA Form 222s for compliance.
Monitor the location’s AB Order Monitoring Program for compliance with corporate, state, and DEA requirements.
Review and verify completion and maintenance of controlled-substance and listed-chemical inventories, including daily, monthly, annual, and biennial counts.
Ensure investigation of significant inventory variances, thefts, and losses.
Ensure ARCOS and state reporting requirements and submissions are completed.
Manage notifications and submissions to state and federal agencies concerning losses of prescription, controlled-substance, or listed-chemical products.
Ensure suspect product notifications are reported to Product Integrity and assist with investigations.
Manage and oversee all aspects of the facility’s Health & Safety Program.
Raise awareness of security issues, bring potential diversion activities and security breaches to CSRA Leadership, identify vulnerabilities, propose reconciliation procedures, and take corrective action when unsafe acts or conditions are observed.
Perform related duties as assigned.