Quality Assurance Manager

MWI Animal Health; Shakopee (MN); Sur place; USD 76 000 - 119 000; Plein temps

Résumé du poste

MWI Animal Health, a leading provider of veterinary and livestock solutions, seeks a Quality Assurance Manager to oversee the Quality Management System (QMS) and ensure GDP compliance at the Shakopee, MN site. This onsite role reports to the Regional Director and collaborates with Regulatory, Quality, and Operations teams.

Responsibilities include audits, training, CAPA execution, and regulatory liaison, with up to 10% travel.

Qualifications

• Bachelor’s degree or equivalent in Life Science, Business, or related field.
• Minimum four years of progressively responsible experience in quality/regulatory operations.
• Strong knowledge of GDP, cGMP, and regulatory requirements.

Responsabilités

• Maintain and monitor the Quality Management System (QMS) at the BU location.
• Ensure compliance with local/state/federal regulations and DEA/EPA/FDA/OSHA requirements.
• Lead audits, inspections, and regulatory inquiries; drive corrective actions (CAPAs).
• Promote a culture of quality, data integrity, and Right the First Time.
• Develop and monitor Quality Objectives and training programs.
• Analyze metrics to drive improvements and cost savings.

Connaissances

Lean Six Sigma

Regulatory compliance

Leadership

Communication

Process improvement

Microsoft Office

Formation

Bachelor’s degree

Outils

Microsoft Office

Description du poste

## Quality Assurance ManagerPostuler: Shakopee, MN: Temps Plein: Publié aujourd'hui: R2617443Our 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!# Ce que vous ferez**Shift Hours:** Monday- Friday 8AM-4:30PM*Please note, flexibility in schedule will be required based on business needs, this can include working different hours or days.***Location:** This position is located onsite at our facility in Shakopee, MN. There is no option for remote or hybrid work.This role is in support of Cencora's veterinary and livestock production solutions marketed through our MWI Animal Health business. MWI Animal Health is a leading brand of Cencora, offering animal health services globally.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. * 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.* 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 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. **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**Ce qu’AmerisourceBergen offre** Nous offrons une rémunération globale concurrentielle. Notre engagement envers nos associés comprend l’offre de programmes d’avantages sociaux complets, diversifiés et conçus pour répondre aux divers besoins de l’ensemble de nos associés. Grâce à notre présence mondiale et nos diverses unités commerciales, nous avons une approche équilibrée des avantages que nous offrons. De nombreux avantages sociaux sont payés par l’entreprise, tandis que d’autres sont offerts par les cotisations des associés. Les offres d’avantages sociaux spécifiques peuvent varier selon l’emplacement, le poste ou l’unité d’affaires.Temps Plein# ****Salary Range\\*****$76,200 - 119,460\\*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.