Manager, Regulatory Quality Systems

Manager Of Regulatory Quality Management Systems

Covetrus is a global animal-health technology and services company dedicated to empowering veterinary practice partners to drive improved health and financial outcomes. We're bringing together products, services, and technology into a single platform that connects our customers to the solutions and insights they need to work best. Our passion for the well-being of animals and those who care for them drives us to advance the world of veterinary medicine.

Covetrus has over 100,000 customers around the globe.

The Manager of Regulatory Quality Management Systems will provide leadership in the development and oversight of the Operation's Quality Management System. This leader will manage a team responsible for key quality functions including Corrective and Preventive Actions, Complaint Management, Documentation & Change Management, Audit & Quality Risk Management. To effectively manage these functions, this role will also have oversight over the company's electronic quality system management software tool.

Additionally, the role will be responsible for achieving quality objectives by implementing and monitoring quality-based metrics and key performance indicators. To be successful, this individual must build and promote a quality culture through collaboration and partnerships, innovation, continuous improvement, and a learning environment that includes knowledge and best practice sharing.

Essential Duties And Responsibilities Include The Following. Other duties may be assigned.

• Provides leadership on & oversight of the Quality Management System within the North America Operations organization including but not limited to Document Control & Management, Change Control & Management, CAPAs & Non-Conformances, and other QS elements as required
• Interfaces with stakeholders including Quality Assurance, Regulatory Compliance & Operations Business Partners to identify and direct system improvements that enhance the efficiency and effectiveness of the Quality Management System
• Facilitates & leads Quality Management System reviews with senior leadership & relevant stakeholders to outline the health & status of the organizational QMS
• Ensures the implementation of a robust CAPA process that drives business partner engagement & continuous process improvement
• Designs and executes a risk management program including communication of risk register and risk mitigation strategy. Conducts gap analysis where needed to facilitate risk management.
• Assists in defining product life cycles across different businesses & establishes processes for development of new products including their successful transition into production
• Champions the utilization and development of an eQMS software application to demonstrate the execution of the organizational Quality Management System
• Responsible for the development & execution of a Training Management Program that ensures timely and effective training & competencies of staff
• Facilitates the establishment & maintenance of the company Audit Program covering both internal and external audits in addition to effective communication of audit outcomes across all businesses
• Assists in the development of quality metrics to drive consistent quality standards & targets throughout the organization
• Advocates for a strong Quality Culture across the business and within the sites

Supervisory Responsibilities

• Will lead a team of direct reports individual contributors across multiple functions

Qualifications:

Education And/or Experience

• Bachelor's degree in a scientific or engineering discipline
• 10+ years industry experience with 5+ years demonstrated of managerial experience
• Broad knowledge of highly regulated operations and GxP environments
• Prior experience in providing leadership and management of quality management systems activities including conducting organizational gap assessments and driving closure to achieve compliance with industry recognized quality management system standards (ex: ISO 9001, ISO
  13485)
• Prior work history with Electronic Quality Management System (eQMS) Software solutions
• Demonstrated ability in providing compliant and practical solutions to complex product quality issues
• Certified Manager of Quality, Certified Quality Engineer or Certified Quality Auditor (or equivalent) a plus Not Required

Competencies (

Skills And Abilities

)

• Proficiency in state and federal regulations with the ability to translate laws into understandable instructions
• Excellent organizational, teamwork, interpersonal, time management skills
• Strong influential leadership, coaching and feedback skills.
• Strong communication skills, both verbal and written, presentation skills.
• Experience with strategic plans, business plans, headcount justification and budgets
• Ability to communicate in a professional manner with co-workers, shareholders, and other contacts
• Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to…