Senior Quality Systems Specialist

Niowave Inc. • Lansing, MI

3d • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in Life Sciences (biology, chemistry, biochemistry, Engineering (chemical, biomedical, industrial), or related field
• 10+ years of GMP/Quality experience in pharmaceutical or biotech environments
• Demonstrated experience with the following: Managing complex quality systems, regulatory audits, and QS software implementations
• Configuring and optimizing QS software systems, ensuring compliance and efficiency
• Advanced 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 organization
• Mentoring/coaching quality team members
• Embraces and models the Niowave Core Values of Teamwork, Courage, Integrity, and Upright Zeal
• Develops and maintains good relationships, gains the confidence of others, and works effectively in a multidisciplinary matrix environment
• Understands how to integrate into a new team/organization
• Appreciates the current state of systems and processes and exercises sound judgment in proposing and implementing improvements
• Understands personal communication and learning styles and adapts approach to connect effectively with others
• Displays excellent interpersonal, written, and oral communication skills
• Possesses strong organizational and project management skills for self and teams
• Possesses a strong interest and ability to coach and mentor staff members and teams
• Demonstrates 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 risk
• Possesses advanced understanding of GMP regulations (FDA, EMA, ICH) and QS principles

Nice To Haves

• Master’s degree in Life Sciences, Engineering, or related field
• 12+ years of GMP/Quality experience in pharmaceutical or biotech environments
• Professional 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 programs
• Working in a facility with radiation regulatory requirements

Responsibilities

• Leads, configures, and optimizes QS software systems, ensuring proper workflows, validations, and integrations for deviations, CAPAs, change control, and document control modules
• Serves as the site-level subject matter expert for regulatory inspections and audits
• Serves as the primary implementer for resolutions to audit and inspection findings, including: Document revisions and creation of SOPs and QS procedures, Updating forms, templates, and training materials, Ensuring proper execution of CAPAs arising from audits
• Leads or supports front room and backroom audit activities, ensuring timely and compliant responses; Implements and maintains a robust audit program
• Conducts complex investigations, root cause analyses, and effectiveness checks
• Mentors and coaches Quality Systems Specialists and technical staff to develop capabilities across the organization
• Leads cross-functional initiatives, influencing stakeholders and building consensus on quality-related decisions
• Drives enterprise-level continuous improvement and system optimization

What This Job Offers

• Job Type: Full-time
• Career Level: Senior