Director of Quality and Regulatory Operations

The Director of Quality and Regulatory Operations will be responsible for day-to-day leadership of the Quality and Regulatory Operations for the US Pharmacy and Supply Chain networks as well as other areas of the organization as may be needed. Responsibilities include the execution of regulatory compliance within the operational processes across the North America supply chain fulfillment network ensuring compliance with all FDA, DEA, Boards of Pharmacy, Department of Health, Department of Agriculture etc, the management of a robust quality/adverse occurrence process. The Director of Quality and Regulatory Operations will oversee the ongoing development and maintenance of the Quality Management System (QMS), day to day Quality Assurance and improvement activities supporting business operations and assuring compliance with existing and newly enacted regulatory requirements applicable to these operations. This role will be responsible for establishing annual objectives and priorities that ensure compliance with regulatory standards and algin with corporate strategy. To be successful, this individual must build and promote a quality culture through collaboration and partnerships, innovation, and continuous improvement and must be skilled with developing and implementing repeatable processes necessary to ensure appropriate compliance in a high volume fast paced environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned

• Provide guidance to pharmacy and supply change networks in areas where performance improvement opportunities based on quality data analytics trends at a frequency needed to meet business targets.
• Drives standardization of adherence to processes across the networks to ensure a wide approach to quality and regulatory compliance.
• Develops and establishes the North America Quality Management System framework including implementing and managing multi-year programs to achieve quality system harmonization, optimization, and continuous improvement across all applicable lines of business.
• Develops, implements, and improves regional North America quality sub-systems for document and change control, training administration, nonconformance/CAPA, new product introduction, risk management, and others assigned.
• Ensures the implementation of a robust nonconformance and CAPA process that prioritizes cross-functional ownership, timeliness of investigation and actions, and clear root cause and corrective action determination and follow through of action plan implementation.
• Responsible for QRO organizational adherence to training deadlines and requirements.
• Supports development and maintenance of policies and procedures.
• Establishes regional North America quality system metrics and ensures processes are in place for periodic reporting by all applicable sites.
• Establishes and maintains the tracking of external audits. Analyzes audit and inspection outcomes and reports results to leadership.
• Provides leadership and direction regarding supplier quality management strategy and systems to ensure the suppliers meet appropriate regulatory requirements and standards set by Covetrus.
• Leads the Performance Improvement (PI) Program including oversight and advancement of key activities, associated thresholds, and plans of correction (where required).
• Identifies & implements organizational best practices aimed at improving operational efficiency, quality performance, customer/consumer outcomes while reducing cost to the business.
• Develop risk mitigation measures related to GMP and regulatory compliance risk areas.
• Organize, facilitate, and attend cross-functional meetings as the QA representative and Quality Subject Matter Expert (SME), as required.
• Lead and mentor a team of Quality and Regulatory professionals to navigate, lead and advance in a matrix organization.
• Advocates within the organization to continually improve Quality mindset & culture.

QUALIFICATIONS:

EDUCATION AND/OR EXPERIENCE

• Bachelor of science degree in a relevant field. Master's degree preferred.
• 8 years industry experience in Quality with 4 years personnel management.
• Leadership experience in regulatory submissions, regulatory assessment, and interactions with regulators (e.g. - FDA).
• Knowledge of the GMP requirements of the pharmaceutical industry as well as quality assurance, quality control, and continuous improvement processes.
• Analytical and critical thinking skills to include software systems, workflows (pharmacy, supply chain, manufacturing), organizational knowledge including applicable industry requirements.
• Ability to learn new software applications as needed.

SUPERVISORY RESPONSIBILITIES

• The role will lead both managers & individual contributors across multiple lines of business within the functions of Quality Assurance, Supplier Quality, New Product Introduction, Materials & Product Validation & Training.
• Directs functions at Business and Facility level, ranging from supply chain to pharmacy to wholesale distribution.

QUALIFICATIONS:

EDUCATION AND/OR EXPERIENCE

CERTIFICATES, LICENSES, REGISTRATIONS

• Certified Manager of Quality, Certified Quality Engineer, or Certified Quality Auditor (or equivalent) desired.
• Six Sigma/Lean certification preferred.

COMPETENCIES (SKILLS AND ABILITIES)

• Excellent organizational, teamwork, interpersonal, time management, influential leadership, coaching and feedback skills.
• Ability to work in fast paced environment, with demonstrated ability to multi-task and resolve problems effectively and efficiently
• Well-developed oral and written communication skills including the ability to write and deliver both informal and formal presentations
• 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
• Proficient with Microsoft Office applications
• Ability to pay attention to detail and retain information readily
• Able to interact with all levels of the organization
• Demonstrate initiative, possession of strong organizational skills and attention to detail
• Aptitudefortranslatingregulatory or quality requirements into businessprocesses.
• Dependable and ethical conduct

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.

• Must be able to read reports and computer screens, hear well enough to communicate with colleagues, walk and stand for extended periods, and operate devices such as computers, telephones, and laboratory instruments.
• Must be able to support travel for on-site work across the North America network. Potential travel overseas is possible. (travel ~ 25%)

Salary may vary depending on factors such as confirmed job-related skills, experience, and location.

However, the pay range for this position is as follows. Sales Positions are eligible for a Variable Incentive

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

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.