Senior Quality Systems Specialist

Niowave • Lansing, MI • 2h ago

::: {align="center"} Senior Quality Systems Specialist :::

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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 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 you need to succeed...

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

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