Manager, Regulatory Quality Systems

reputed company 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. reputed company has over 100,000 customers around the globe. SUMMARY The Manager of Regulatory Quality Management Systems will provide leadership in the development and reputed company 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 reputed company 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, reputed company 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 & reputed company of the Quality Management System reputed company 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 & reputed company 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 reputed company 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 reputed company the sites

SUPERVISORY RESPONSIBILITIES

• Will reputed company 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 reputed company compliance with industry recognized quality management system standards (ex: ISO 9001, ISO13485)
• Prior work history with Electronic Quality Management System (eQMS) Software solutions
• Demonstrated ability in providing compliant and practical solutions to reputed company 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 problems.
• Dependable and ethical conduct
• Experience with reputed company Office reputed company, Word, and PowerPoint
• Ability to pay attention to detail and retain information readily
• Able to interact with reputed company levels of the organization
• Demonstrate initiative, possession of strong organizational skills and attention to detail

We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program:

• 401k savings & company match
• Paid time off
• Paid holidays
• Maternity leave
• Parental leave
• Military leave
• Other leaves of absence
• Health, dental, and vision benefits
• Health savings accounts
• Flexible spending accounts
• Life & disability benefits
• Identity theft protection
• Pet insurance
• Certain positions may include eligibility for a short-term incentive plan

Salary may vary depending on factors such as confirmed job-reputed company skills, experience, and location. It is not typical for an individual to be hired at or near the top end of the range for their role. Compensation decisions are dependent upon the facts and circumstances of each case. Sales Positions are eligible for a Variable Incentive. The pay range for this position is as follows: $86,300-$123,300 reputed company is an equal opportunity/affirmative action employer. reputed company qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. Apply tot his job Apply To this Job