Quality Systems Consultant​/Senior Quality Systems Consultant

Sanova is a life sciences consulting firm specializing in regulatory, scientific, data analytics, and litigation support. We curate expert teams, both internal and external, to provide strategic, innovative, and practical solutions tailored to each client’s unique needs.

• We’re a team of scientists, strategists, and problem-solvers delivering exceptional work grounded in good science, thoughtful analysis, and a deep understanding of complex regulatory systems.
• We thrive on challenging projects that demand critical thinking and innovative solutions.
• We believe in collaborative problem solving
  , where diverse perspectives shape smarter outcomes. Our success lies in how well we work together.
• We’re driven by value and impact
  . That means going beyond deliverables and looking for ways to solve real problems to create value for our clients.

If you’re passionate about navigating complexity, working with integrity, and contributing meaningfully to practical solutions for our clients — we’d love to hear from you.

We’re looking for a Quality Systems Consultant or Senior Quality Systems Consultant who will:

• Partner with clients in the nicotine and harm-reduced products sector (e.g., ENDS, oral nicotine, heated tobacco products) to design, implement, and improve quality management systems that are practical, right-sized, and inspection-ready
• Apply cGMP and quality system principles to real-world manufacturing, supply chain, and product development settings, including FDA’s tobacco product manufacturing practice (TPMP) expectations
• Draft, review, and revise quality policies, SOPs, work instructions, forms, and quality manuals that are clear, compliant, and easy for client teams to use
• Conduct gap assessments and internal and supplier audits, and translate findings into prioritized, actionable remediation plans
• Work with our internal quality and regulatory experts to align client quality systems with regulatory submissions (e.g., PMTAs) and FDA inspection readiness
• Own assigned work streams from scoping through delivery, working independently with minimal supervision

• Lead client engagements, serving as the primary point of contact and directing project teams from scoping through delivery
• Serve as a trusted advisor to client leadership on quality strategy, inspection readiness, and building a sustainable quality culture
• Mentor and provide technical guidance to team members and contribute to the development of Sanova’s quality consulting offerings

This is a fully remote position, with occasional travel to client sites as required by project work.

• Bachelor’s degree in life sciences, chemistry, engineering, or a related technical field
• Advanced degree or quality certification (e.g., ASQ CQA, CQE, or CMQ/OE) is a plus

• 7+ years (10+ years for the Senior level) of hands‑on quality assurance or QMS experience in an FDA-regulated or cGMP environment (e.g., pharmaceuticals, medical devices, dietary supplements, food, or tobacco/nicotine products)
• For the Senior level, 5+ years in a quality systems leadership role, such as building, leading, or remediating a QMS
• Demonstrated experience writing and implementing quality policies, SOPs, and other controlled documents
• Experience conducting audits, gap assessments, investigations, and CAPA
• Experience with nicotine or tobacco products and familiarity with FDA CTP requirements is a plus
• Consulting or other client-facing experience is a plus
• Practical, pragmatic approach to applying QMS and cGMP principles, with the judgment to build systems that fit a client’s size, maturity, and products
• Strong problem solver who can assess complex…