Senior Director, Quality & Regulatory Affairs at Niowave Inc.

Lansing, Michigan, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Aug, 26

Salary

0.0

Posted On

14 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Systems, Regulatory Compliance, cGMP, FDA Regulations, EMA Regulations, CAPA Systems, Quality Risk Management, Deviation Investigations, Audit Management, Strategic Leadership, Cross-functional Leadership, Project Management, Inspection Readiness, Succession Planning, Radiopharmaceutical Manufacturing

Industry

Pharmaceutical Manufacturing

Description

Senior Director, Quality & Regulatory Affairs Who we are… 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. Who you are… 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. How you will make an impact… 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. What you need to succeed… * 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 Great to have… * 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) Other things to note… * Full-time position * The 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 shifts * This position will have regular working hours Monday - Friday within the standard operating hours * There is an expectation of adjusting working hours outside the standard hours to meet operational requirements as needed * Niowave has multiple locations within the Lansing area and travel between locations is expected in the role Please provide a cover letter specifically describing the nature of your interest & expertise.

Responsibilities

Lead the company's quality and regulatory strategy for radioisotope production under a cGMP operating model. Provide strategic oversight for quality assurance, quality control, regulatory compliance, and continuous improvement initiatives.