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Manager, Quality & Regulatory Operations, Process & Technology

$67.1k - $95.8k
Full-time

Covetrus

Covetrus is a global animal-health technology and services leader dedicated to empowering veterinary practice partners to drive improved health and financial outcomes. We bring 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.

SUMMARY

The Manager, Quality & Regulatory Operations, Process & Technology is a key member of the QRA team, responsible for identifying, designing, implementing, and sustaining technology-enabled improvements across the Quality and Regulatory function. This role partners closely with Quality, Regulatory, Operations, Legal, Pharmacy, Operations and other leaders to simplify complex regulated processes, eliminate manual work, and build scalable automation using AI, low-code platforms, workflow tools, dashboards, and integrations. At least 60% of this role is hands-on building and transforming, not simply identifying opportunities; success is measured by the quality, adoption, and business impact of the solutions you create.

This role is well suited for a Quality or Regulatory subject matter expert who builds. You have lived inside a regulated function — quality, regulatory, compliance, or legal — in a highly regulated industry, and along the way you became the person your department went to when something needed to be automated, tracked, or reported. You may have held a title such as Quality Systems Manager, Regulatory Operations Manager, QA Specialist, Compliance Analyst, Validation Specialist, Senior Paralegal, Quality Engineer, or something else. You know what a regulator would ask for, you know why the SOP says what it says, and you have personally built the trackers, workflows, dashboards, and AI-assisted tools that kept the function running. A formal technology title is not required; demonstrated building is.

This role is not well suited for a candidate whose automation experience sits entirely outside a regulated or controlled function, a candidate who wants to own a roadmap and hand the building to someone else, or a candidate seeking a pure software engineering role. We build on approved enterprise low-code and AI platforms, including Microsoft Power Platform and Claude, rather than a bespoke stack.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Design, develop, test, deploy, and sustain technology-enabled solutions that automate and streamline Quality and Regulatory processes, and own those solutions thereafter so they remain reliable, compliant, adopted, and continuously improved.
  • Build workflows, AI agents, dashboards, forms, integrations, scripts, and low-code applications using approved enterprise technologies, including Microsoft Power Platform (Power Automate, Power Apps, Power BI, Copilot Studio) and Claude, our approved enterprise AI assistant.
  • Use Claude to build practical solutions for regulated work, including drafting and reviewing controlled documents, summarizing investigations and audit findings, analyzing complaint and nonconformance data, and creating reusable prompts, projects, and skills the QRO team can run themselves.
  • Define how Claude and other AI tools are used responsibly within a regulated function, including appropriate use cases, human review points, source verification, confidentiality, and documentation of AI-assisted work.
  • Rapidly prototype solutions, iterate with business partners, and continuously improve based on user feedback.
  • Partner with Quality and Regulatory process and system owners to understand current-state workflows, pain points, and improvement opportunities, and facilitate process mapping and workflow analysis to identify inefficiencies, bottlenecks, manual work, and compliance risks.
  • Develop future-state process designs that improve efficiency while maintaining or strengthening regulatory compliance and quality standards.
  • Apply regulatory judgment to automation decisions: determine what can be automated, what must remain under human review, and how to defend either choice to an auditor.
  • Prioritize automation and optimization opportunities based on business impact, effort, regulatory risk, and return on investment, and maintain a pipeline of continuous improvement initiatives.
  • Drive process improvements across QMS processes including CAPA, Change Control, Document Control, Training, Audits, Supplier Quality, Complaints, Nonconformance, Management Review, and related quality workflows, and support optimization and configuration of Quality Management Systems and related digital platforms.
  • Develop dashboards and metrics providing visibility into process performance, cycle times, compliance indicators, and operational efficiency.
  • Ensure solutions meet data integrity, validation, cybersecurity, records retention, and regulatory requirements, and that they remain inspection-ready.
  • Serve as the QRA function’s technology, automation, and AI subject matter expert, including as the internal champion for Claude adoption across quality and regulatory teams.
  • Evaluate emerging technologies and AI capabilities for practical application within regulated quality and regulatory processes, and establish best practices, standards, and governance for automation across the organization.
  • Partner with QRA leadership on change management, training, and adoption, and coach team members on new tools, workflows, and automation capabilities.
  • Collaborate with IT, Cybersecurity, and enterprise technology teams when more complex integrations or software engineering support is required.
  • Measure and communicate realized benefits, including reduced manual effort, faster cycle times for investigations, CAPAs, change controls, registrations, and document approvals, increased process standardization, improved operational visibility, risk reduction, and cost savings.
  • Perform other duties as assigned.

QUALIFICATIONS:

Education and/or Experience

  • Bachelor’s degree required, degree in a STEM, engineering, information systems, life sciences, legal, or business discipline preferred.
  • 5+ years of experience working within a Quality, Regulatory, Compliance, Legal, or equivalent control function in a highly regulated industry, such as life sciences, medical device, pharmaceutical, animal health, food, aerospace, energy, or financial services. This is a requirement, not a preference.
  • Demonstrated experience improving business processes, automation, digital transformation, or operational excellence within that regulated environment.
  • Hands-on experience building automation using Microsoft Power Platform or comparable workflow and automation technologies. Candidates should be prepared to walk us through something they built, who used it, and what it replaced.
  • Working knowledge of quality management system processes and the regulatory frameworks that govern them, such as FDA, ISO, GxP, DEA and state board requirements, or an equivalent regime in the candidate’s industry.
  • Experience with validation, data integrity, or electronic records and signature requirements, strongly preferred.
  • Hands-on experience using an enterprise AI assistant such as Claude or Microsoft Copilot in day-to-day work, strongly preferred.
  • Salesforce.com and/or enterprise QMS platform experience preferred.

Competencies (Skills & Abilities)

  • Demonstrated ability to build solutions, not simply recommend improvements.
  • Strong systems thinking with excellent analytical, process-design, and simplification skills.
  • Regulatory fluency, with the ability to translate between compliance requirements and technical design without losing either.
  • Advanced proficiency in Microsoft Office, particularly Excel (e.g., formulas, pivot tables, data analysis).
  • Comfortable leveraging AI as part of daily work and excited to evaluate emerging technologies.
  • Skilled at prompting and directing AI tools such as Claude to produce reliable output, and disciplined about verifying what they return before it enters a controlled process.
  • Excellent written and verbal communication skills, with the ability to translate technical concepts for quality, regulatory, and business audiences.
  • Strong attention to detail, with a focus on accuracy, consistency, and operational rigor.
  • Ability to work independently while managing multiple priorities and deadlines.
  • Curious, self-directed, business-minded, and comfortable challenging existing ways of working while respecting why the control exists.

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.

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-related 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

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.

Vacancy posted 2 days ago
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