Senior Director, Quality & Regulatory Affairs

Niowave Inc. • Lansing, MI

20h • Onsite

About The Position

The Quality & Regulatory Affairs department leader owns the company quality and regulatory strategy for radioisotope material production under a cGMP operating model, including material classification, GMP entry point, regulatory position, and partner-facing quality narrative. This role provides strategic leadership and oversight of quality assurance, quality control, regulatory compliance, quality systems, inspection readiness, and continuous quality improvement initiatives.

Requirements

• Bachelor’s degree in a scientific, engineering, or related technical discipline
• 15+ years of experience in pharmaceutical, biotechnology, or radiopharmaceutical industry
• 10+ years of leadership experience in Quality Assurance / Quality Systems
• 8+ years’ experience managing and leading teams and departments, scaling them to the needs of the organizational mission and objectives
• Demonstrated ability to build cohesive groups, establish career development tracks, and succession planning to develop and sustain high functioning teams
• Strong working knowledge of FDA, EMA regulations and cGMP requirements
• Demonstrated experience managing quality systems, audits, and regulatory inspections
• Proven effective leadership in cross-functional environments and departmental leadership
• Deep experience with deviation investigations, CAPA systems, and quality risk management
• 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
• Demonstrates strategic thinking with creative and excellent problem solving and decision-making skills with ability to critically interpret and use data to manage risk
• Demonstrates high accountability, visionary leadership with excellent management aptitude both in theory and application

Nice To Haves

• Advanced degree in a scientific, engineering, or regulatory discipline
• 15+ years of management experience
• Experience in radiopharmaceutical manufacturing or nuclear medicine products
• Experience in a CDMO environment supporting multiple clients
• Experience supporting regulatory submissions (IND, NDA, ANDA, or DMF)

Responsibilities

• Owns the company quality and regulatory strategy for radioisotope material production under a cGMP operating model.
• Provides strategic leadership and oversight of quality assurance, quality control, regulatory compliance, quality systems, inspection readiness, and continuous quality improvement initiatives.

What This Job Offers

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