Quality Systems Consultant/Senior Quality Systems Consultant

Our Company 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.The Position – Quality Systems Consultant / Senior Quality Systems ConsultantWe’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 useConduct 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 readinessOwn assigned workstreams from scoping through delivery, working independently with minimal supervisionAt the Senior level, you’ll also:Lead client engagements, serving as the primary point of contact and directing project teams from scoping through deliveryServe as a trusted advisor to client leadership on quality strategy, inspection readiness, and building a sustainable quality cultureMentor and provide technical guidance to team members and contribute to the development of Sanova’s quality consulting offeringsThis is a fully remote position, with occasional travel to client sites as required by project work.Position Requirements:EducationBachelor’s degree in life sciences, chemistry, engineering, or a related technical fieldAdvanced degree or quality certification (e.g., ASQ CQA, CQE, or CMQ/OE) is a plusExperience7+ 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 QMSDemonstrated experience writing and implementing quality policies, SOPs, and other controlled documentsExperience conducting audits, gap assessments, investigations, and CAPAExperience with nicotine or tobacco products and familiarity with FDA CTP requirements is a plusConsulting or other client-facing experience is a plusCompetenciesPractical, pragmatic approach to applying QMS and cGMP principles, with the judgment to build systems that fit a client’s size, maturity, and productsStrong problem solver who can assess complex situations, identify root causes, and recommend sensible solutionsExcellent technical writer, able to draft clear, concise, and well-organized policies and proceduresSelf-directed and accountable; able to prioritize, manage deadlines, and deliver high-quality work without close supervisionHighly collaborative and effective in a remote working environment, building strong relationships with team members and clientsDetail-oriented and organizedCurious and adaptable, interested in working on widely varying projects across diverse products and clientsPay and Benefits: Base salary for this role ranges $110,000 - $130,000 for the Consultant level and $130,000 - $160,000 for the Senior Consultant level, not including bonus or other benefits. Level and title will be determined based on experience and qualifications. Pay within the range will be based on experience and the degree to which a candidate’s background meets the job requirements and responsibilities. Our minimum billable target is 1392 hours, which considers that our team members take all available PTO.We offer the following benefits to all full-time team members:Fully Remote Work: We are a fully remote team. Our team members manage their working hours based on team and project needs, client commitments, and billable hour requirements. This means that PTO is not required for personal appointments or activities if balanced out over the working day or workweek. PTO: In addition to day-to day work flexibility, we offer 28 days of paid time off annually for any reason.Work Wise Program: Our WorkWise program provides new team members with $1000 to help equip a home office or to support optimizing remote work, with $1000 to refresh and update equipment every 2 years. Every team member receives a monthly cell phone reimbursement of $75 and a WorkWise monthly payment of $125 to support the expenses of a home office. Healthcare through QSEHRA. We offer a QSEHRA (Qualified Small Employer Health Reimbursement Arrangement) that reimburses up to the federal maximum. You choose and own your healthcare coverage and we reimburse you.401k: We offer a 401k program with a match of 4% on your first 5%. New Business Bonus: We encourage and support team members in developing business, and we provide team members with bonuses based on gross receipts from new business generation. It’s a way to reward our team members for investing in our future.Bonus: We offer team members a discretionary bonus at the end of each year based on individual and company performance.Reimbursement of Business Expenses/Conference Attendance: We provide access to software, applications and systems needed to perform our work. We also encourage and support team member participation in industry events and conferences.