Senior Director, Quality & Regulatory Affairs

Niowave•Lansing, MI

13d•Onsite

About The Position

We are a group of scientists, engineers, designers, technicians, and many others who are dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We also enjoy darts, cornhole, ping-pong, take-out for group lunches, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living. You are a seasoned professional who is inspired by developing team members to reach their greatest potential. You are energized by helping others succeed and by the opportunity to influence patient outcomes through deliberate quality practices. Your job satisfaction is measured by collaboration and synergy you instill in cross-functional team members, enabling them to achieve optimal outcomes. You model a “seek first to understand” environment and celebrate the journey as well as the destination. You wholeheartedly embrace leadership as a choice, a responsibility, and a remarkable privilege to positively impact the lives of others. 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

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, including material classification, GMP entry point, regulatory position, and partner-facing quality narrative.
Provides strategic leadership and oversight of quality assurance, quality control, regulatory compliance, quality systems, inspection readiness, and continuous quality improvement initiatives.
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.