Senior Manager, Quality & Regulatory

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.

Location: Remote, USA with travel required to facilities based in the United States

The Senior Quality and Regulatory Manager will provide overall company leadership and direction for Quality and Regulatory Compliance for the MWI U.S. Operations. This position is compliance critical, and responsibilities include ensuring proper compliance with all division, corporate and government regulatory requirements. The Senior Quality and Regulatory Manager will be part of a high-caliber International Quality, Regulatory and Continuous Improvement team.

Primary Responsibilities:

• Execute the quality and compliance strategy within the organization, ensuring adherence to standardized processes aligned with Cencora policies
• Acts as MWI's U.S. management representative to Cencora and perform all duties and tasks associated with that designation
• Implement and maintain a comprehensive Quality Management System (QMS) to ensure compliance with SOPs and Business Processes
• Lead the strategy surrounding Quality Audits, focusing on the development and improvement of internal quality audit processes and external third-party partners
• Develop and manage the Corporate Vendor Quality Audit Program, including inspection strategy and audit schedule framework
• Ensure compliance with DSCSA (Drug Supply Chain Security Act) requirements for product traceability, including GS1 barcode systems.
• Lead all regulatory activities and submissions related to our VetOne and Securos Brands. Ensure that all due dates for regulatory milestones for the MWI Private brands in support of both pre- and post-approval submissions
• Track and report company quality data including complaints, nonconforming product, and corrective/preventive action activities related to MWI private label brands
• Design and coordinate the preparation and ongoing review of policies, procedures, training materials and other communication tools to ensure departments meet compliance requirements
• Develop, implement, and monitor quality improvement programs, ensuring adherence to regulatory requirements
• Execute quality performance improvement plans and partner with local teams and departments to implement improvements as needed
• Support local training and educational programs as needed
• Oversee documentation, record-keeping, and internal audits to verify QMS effectiveness
• Oversee other key compliance standards relevant to our operations, such as Covered Business Partner Program, TAA Compliance, Food Safety Verification Program etc.
• Ensure compliance with federal, state, international regulations
• Collaborate closely with cross-functional teams (sourcing operations, legal, Cencora QRO, Customer service etc..) to integrate regulatory requirements to provide strategic guidance and training to internal stakeholders
• Support all inspection readiness and regulatory agency data requests during site inspections
• Monitor and interpret changes in applicable regulations to provide strategic guidance and training to internal stakeholders
• Manage a team of 1-3 direct reports
• Continue to strategically evolve company quality management system
• Perform other duties as assigned

Experience and Educational Requirements:

• B.S. degree in an appropriate Science discipline with a minimum of five (5) years of experience with in-depth knowledge of pharmaceutical and medical devices

• Certified Regulatory Compliance Manager (CRCM) preferred

• Strong understanding of relevant regulations and industry standards

• Experience in auditing, risk management, and/or quality management.

• Knowledge of QMS software

• Audit experience required

• Experience with complex regulatory filing(s) and post-approval regulatory activities

Minimum Skills, Knowledge, and Ability Requirements:

• Ability to influence and work effectively with various stakeholders, regions, and cultures

• Result-driven with ideas to drive continuous improvement process

• Demonstrated strong cross-functional leadership skills

• Excellent written and verbal communication and interpersonal, negotiation, judgement, and conflict resolution skills

• Able to communicate complex information clearly and succinctly, verbally, and written

• Ability to build relationships and work collaboratively with all levels of individuals across the organization and externally

• Detail-oriented with excellent organizational and time management skills

• Ability to function in a high pace environment, multi-task, manage and prioritize various and differing projects, as well as work effectively toward numerous deadlines

• Demonstrated analytical capabilities with the ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with regulatory compliance, formulate action plans, and implement solutions

• Demonstrated ability to anticipate potential problems and risks related to quality management systems expectations and regulatory compliance, formulate plans, and implement solutions

• Knowledge and understanding of the drug development process, scientific methods and thought processes, specifically the manufacturing process, to ensure regulatory information is current

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In 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 https://www.virtualfairhub.com/cencora

*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.

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 company's 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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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