Senior Quality Systems Specialist

Who We Are…We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living.Who You Are…You are someone who genuinely cares about doing things the right way and finds purpose in work that requires integrity, structure, and trust. Quality and compliance resonate with you because you enjoy bringing clarity to complexity and creating systems that people can rely on. You are naturally collaborative and value building strong relationships, listening to different perspectives, and helping teams align in practical and meaningful ways. You take pride in being dependable and thoughtful, approaching challenges with sound judgment and a steady, solutions-oriented mindset. You are motivated by continuous improvement and enjoy helping others learn, grow, and succeed. Words that describe you include thoughtful, collaborative, principled, dependable, and grounded.What You Can Expect To Work On…The Senior Specialist is a highly experienced subject matter expert who leads strategic Quality Systems initiatives, supports audit and inspection strategy, and influences organizational compliance direction. This role serves as a key advisor across functions, mentors team members, and drives continuous improvement and regulatory excellence. This role serves as a trusted collaborator to leadership, assists in guiding team direction, and leads efforts in high-visibility regulatory environments. Leads, configures, and optimizes QS software systems, ensuring proper workflows, validations, and integrations for deviations, CAPAs, change control, and document control modulesServes as the site-level subject matter expert for regulatory inspections and auditsServes as the primary implementer for resolutions to audit and inspection findings, including:Document revisions and creation of SOPs and QS proceduresUpdating forms, templates, and training materialsEnsuring proper execution of CAPAs arising from auditsLeads or supports front room and backroom audit activities, ensuring timely and compliant responses; Implements and maintains a robust audit programConducts complex investigations, root cause analyses, and effectiveness checksMentors and coaches Quality Systems Specialists and technical staff to develop capabilities across the organizationLeads cross-functional initiatives, influencing stakeholders and building consensus on quality-related decisionsDrives enterprise-level continuous improvement and system optimizationWhat You Need To Succeed… Bachelor’s degree in Life Sciences (biology, chemistry, biochemistry, Engineering (chemical, biomedical, industrial), or related field10+ years of GMP/Quality experience in pharmaceutical or biotech environmentsDemonstrated experience with the following:Managing complex quality systems, regulatory audits, and QS software implementationsConfiguring and optimizing QS software systems, ensuring compliance and efficiencyAdvanced proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook, with the ability to create professional documents, presentations, and reports, and efficiently manage communication and workflow across the organizationMentoring/coaching quality team membersEmbraces and models the Niowave Core Values of Teamwork, Courage, Integrity, and Upright ZealDevelops and maintains good relationships, gains the confidence of others, and works effectively in a multidisciplinary matrix environmentUnderstands how to integrate into a new team/organizationAppreciates the current state of systems and processes and exercises sound judgment in proposing and implementing improvementsUnderstands personal communication and learning styles and adapts approach to connect effectively with othersDisplays excellent interpersonal, written, and oral communication skillsPossesses strong organizational and project management skills for self and teamsPossesses a strong interest and ability to coach and mentor staff members and teamsDemonstrates strategic thinking with creative and excellent problem solving, root cause investigation, and decision-making skills with ability to critically interpret and use data to manage riskPossesses advanced understanding of GMP regulations (FDA, EMA, ICH) and QS principlesGreat to have… Master’s degree in Life Sciences, Engineering, or related field12+ years of GMP/Quality experience in pharmaceutical or biotech environmentsProfessional certifications (e.g., ASQ Certified Quality Auditor, Six Sigma, Lean)Experience with the following:Leading or supporting regulatory inspections (FDA, EMA)Implementing QS software systems, resolving audit findings, and creating training programsWorking in a facility with radiation regulatory requirementsOther Things To Know…Full-time positionThe company’s standard operating hours are Monday thru Friday 6:00 a.m. – 6:00 p.m. with production related activities requiring 24/7/365 shiftsThis position will have regular working hours Monday - Friday within the standard operating hoursThere is an expectation of adjusting working hours outside the standard hours to meet operational requirements as neededNiowave has multiple locations within the Lansing area and travel between locations is expected in the rolePlease provide a cover letter specifically describing the nature of your background and experience as it relates to this position.