Quality Assurance Manager

Cencora • Shakopee, MN

24d • $76,200 - $119,460 • Onsite

About The Position

The Quality Assurance Manager supports Cencora’s veterinary and livestock production solutions through its MWI Animal Health business. 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 the business unit location maintains an effective Quality Management System and meets security and regulatory requirements consistent with company policies and applicable state and federal regulations. The position has authority and responsibility for maintaining quality-system compliance and fostering quality and regulatory awareness throughout the operation.

The manager maintains, executes, and monitors the location’s Quality Management System and Good Distribution Practices, oversees required licenses and registrations, and serves as the primary liaison with regulatory agencies. The role also oversees quality, health and safety, security, and regulatory assessments and training; supports investigations, corrective and preventive actions, change control, and risk management; and uses metrics and trend analysis to monitor performance and improve processes.

The position has responsibility for controlled-substance compliance, including Schedule 2 documentation and order forms, inventory controls, required reporting, and investigation and notification of losses. It also manages the facility’s Health & Safety Program, monitors security controls, and helps identify and address vulnerabilities. The position is onsite at the Shakopee, Minnesota facility, works a Monday–Friday schedule with stated hours of 8:00 a.m.–4:30 p.m., requires flexibility based on business needs, and may require travel up to 10%.

Requirements

• A four-year bachelor’s degree in a field such as Life Science, business administration, or a related field, or an equivalent combination of education and experience.
• A minimum of four years of directly related and progressively responsible experience.
• Process-oriented approach and continuous-improvement experience, such as Lean Six Sigma.
• Good understanding of local, state, and federal laws and regulations and of 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 and leadership skills.
• Effective 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 skills.
• Excellent problem-solving skills and 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 as required by business needs.

Responsibilities

• Maintain, execute, and monitor the business unit location’s Quality Management System, Good Distribution Practices, and compliance with applicable 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 location and regulatory agencies; manage or assist with inspections, investigations, and information requests.
• Conduct required Quality, Health & Safety, Security, and Regulatory Assessments.
• Promote a culture of quality, including understanding of GDP, good documentation practices, data integrity, and good storage, distribution, and transportation practices.
• Collaborate with the location on implementation of annual Quality Objectives and key business drivers for distribution center operations.
• Support and monitor location 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, including root-cause analysis and corrective actions.
• Generate monthly and quarterly metric reports for regional leadership and participate in regional quality metric calls and meetings.
• Represent Quality and Regulatory on the location leadership team and monitor compliance with corporate policies for temperature and security monitoring, alarm systems, access cards, key control, and CCTV.
• Manage and maintain distribution center Power of Attorney documentation for signers of Schedule 2 order forms.
• Review DEA Form 222 Schedule 2 order forms for transaction compliance.
• Monitor the location’s AB Order Monitoring Program for compliance with corporate, state, and DEA requirements.
• Verify that controlled-substance and listed-chemical inventories are completed and maintained according to corporate policy, including daily, monthly, annual, and biennial counts.
• Ensure significant inventory variances, thefts, and losses are investigated.
• Ensure ARCOS and state reporting requirements and submissions are completed in accordance with corporate, state, and federal requirements.
• Manage notification and submission of correspondence to state and federal agencies regarding 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 prompt corrective action when unsafe acts or conditions are observed.
• Perform related duties as assigned.

Benefits

• Medical, dental, and vision care.
• 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.
• Training programs, professional development resources, and mentorship opportunities.
• Employee resource groups and volunteer activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager