Director of Quality Assurance and Improvement
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 is headquartered in Portland, Maine, with more than 5,000 employees, serving over 100,000 customers around the globe.
Provides leadership, strategic direction, and management of quality assurance/quality control and improvements at the pharmacy facilities. The Director interfaces, directs, and supports pharmacy operations at all locations with all quality, regulatory, and change management/process improvement initiatives. Manages quality teams and advises pharmacy/compliance staff on regulatory and quality issues. Drives continuous process improvements for all quality programs by using a variety of methodologies.
The Director of Quality Assurance and Improvement position will be located in Portland, ME
Expected travel – up to 25%
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Develop quality strategy and roadmap that drives continuous improvements centered on medication error prevention, compounding technique and best practice standards aimed at ensuring compliance with all state and federal regulations and accreditations programs.
- Lead and develop a team of high performing employees focused on supporting training, operational efficiency, and clinical excellence across multiple sites thought continuous process improvement.
- Lead the development and maintenance of, comprehensive QA/QC and compliance programs and processes with projects aimed at identifying process improvement opportunities and analyzing metrics used to drive performance.
- Serve as the accreditation and standards expert and translate these standards to ensure QA/QC, and compliance programs are best in class.
- Ensures alignment with key stakeholders, including Legal, Pharmacy Operations, Safety, and Compliance.
- Internal liaison to support all state, federal, and accreditation audits.
- Serves as primary resource for technical and quality initiative and standardizations related to training programs, standard operating process, and products.
- Oversee ongoing maintenance of pharmacy quality management system.
- Manages requests received from vendors, internal team members, state and federal regulatory bodies, and any other regulatory authorities relating to QA/QC, improvement, and compliance initiatives.
- Manages workflow and the compliance audit process to ensure timely completion and in agreement with all state and federal regulatory bodies.
- Perform annual risk analysis and develop compliance programs to ensure timely CAPA's are executed.
- Oversees and conducts site visits and compliance audits on a regular basis. Supports multiple locations in US.
- Manage a team 5-10 employees
EDUCATION AND/OR EXPERIENCE
- Bachelors' degree, Master's Preferred
- 5+ years Quality and Process Improvement experience, 3+ years auditing experience in a regulatory compliance environment
- Analytical and critical thinking skills to include: quality programs, process improvements
- Preferred: pharmacy software systems, pharmacy workflow, the practice of pharmacy, organizational knowledge, and complex pharmacy compliance requirements.
- Learn new software applications as needed.
CERTIFICATES, LICENSES, REGISTRATIONS
- ASQ Certification, Pharmaceutical GMP Professional Certification, CPGP is a plus
- Lean Six Sigma Green Belt or Black Belt, or similar continuous improvement methodology
- ISO Certification, program development and audit readiness experience is a plus
COMPETENCIES (SKILLS AND ABILITIES)
- Proven analytical and critical thinking skills
- Strong computer skills: proficient in MS Office Suite including SharePoint
- Ability to take direction, provide instruction, and recognize the importance of and timing for reaching out to others to ensure high quality work output/performance
- Demonstrate initiative, possession of strong organizational skills and attention to detail is critical for success on the job
- Function as part of a team with other team members within the company
- Strong communication skills both verbal and written are necessary as well as an ability to work with everyone from front-line employees to top level executives
- All job functions are to be completed with a high level of confidentiality
- Work in fast paced environment, with demonstrated ability to multi-task and resolve problems effectively and efficiently
- Proven leadership, assertiveness, interpersonal and analytical skills proficiency is essential
- Well-developed oral and written communication skills including the ability to develop and deliver both informal and formal presentations
- Prepare clear, concise documents for general and technical needs
PHYSICAL DEMANDS/WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Pet friendly environment
- Extensive computer work
Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.