Overview

The Director, Quality is responsible for leading and overseeing all quality activities supporting the manufacture, testing, release, and stability of radiopharmaceutical drug products and APIs within a cGMP-regulated environment. This role provides both strategic and hands-on leadership to build, operate, and continuously improve the Quality unit in a fast-growing CDMO organization. The position ensures quality control, quality assurance, validation, regulatory, and training activities are compliant, efficient, and aligned with rapid development timelines and lean manufacturing principles, while supporting the development of team capabilities and scaling of NorthStar’s systems, processes, and culture.

Responsibilities

Building & Scaling Quality in an Innovating Environment

• Help design, implement, and evolve quality systems, processes, procedures, and workflows suitable for an emerging and growing CDMO operation.
• Lead the development, authorship, and maintenance of SOPs, specifications, and templates with a “right sized” startup mindset.
• Support selection, qualification, and lifecycle management of laboratory equipment, software and analytical tools.
• Partner with Business Development, Facilities, Manufacturing, Engineering, and Analytical Development to identify gaps and implement practical solutions quickly.

cGMP Compliance & Quality Systems

• Ensure all activities comply with applicable cGMP requirements (FDA 21 CFR Parts 11, 210 and 211), data integrity expectations, and global regulatory standards.
• Lead or support investigations related to deviations, OOS/OOT results, and atypical events, driving timely and effective root cause analysis and CAPAs.
• Actively participate in audits and inspections, including facility readiness, inspection hosting, and response development.
• Maintain strong inspection readiness through disciplined documentation, training, and laboratory practices.

Analytical Methods & Technical Support

• Support method validation, verification, qualification, and transfer for radiopharmaceutical specific test methods, including radiochemical purity, identity, and sterility/endotoxin testing.
• Work closely with Analytical Development to transition early phase methods into routine QC use.
• Provide technical troubleshooting support for analytical methods, equipment issues, and data anomalies.

Continuous Improvement & Strategy

• Drive continuous improvement initiatives focused on efficiency, compliance, automation, and right-first-time execution.
• Contribute to QA strategy, including integrated software, process flows, and data integrity/scalability aligned with company growth.
• Contribute to QC strategy, including laboratory expansion, equipment qualification, and capability building aligned with company growth.
• Contribute to Validation strategy, including life cycle management, in-house capabilities, and scalable phase appropriate actions aligned with company growth.
• Monitor industry trends, regulatory updates, and emerging technologies relevant to radiopharmaceutical quality.

CDMO & Client Engagement

• Support quality aspects of CDMO programs, including client onboarding, quality agreements, knowledge transfer, technical discussions, and program execution.
• Support project management team, addressing testing approaches, timelines, deviations, and data questions.
• Support technology transfer activities from client or internal development programs into manufacturing and QC operations.
• Team Leadership & Development
• Directly manage and mentor a growing quality team, leading by example in both technical execution and quality mindset.
• Train and coach analysts on cGMP expectations, data integrity, and phase appropriate processes.
• Foster a collaborative, problem solving culture well suited for an emerging company.

Early Development

• Build and begin shaping core Quality processes and systems, not just maintaining existing ones.
• Effectively balance strategic priorities with hands-on execution, moving between planning, documentation, and operational support as needed.
• Navigate ambiguity and a fast-paced environment, bringing structure and clarity while maintaining momentum.
• Establish a pragmatic, enabling Quality approach that supports safe, compliant manufacturing without creating unnecessary barriers.

Qualifications

Bachelor’s Degree in a Microbiology, Biochemistry, Chemistry, Pharmaceutical Sciences, or related scientific discipline and minimum ten (10) years of Quality experience in a cGMP pharmaceutical, biotech, or radiopharmaceutical manufacturing with a minimum of five (5) years of management experience; or equivalent combination of education and experience. 

 

Additional required experience includes:

• Demonstrated experience working in small companies or startup environments, with a willingness to be hands on.
• Experience with radiopharmaceuticals, nuclear medicine, or radioactive materials testing strongly preferred.

Experience supporting manufacturing operations with tight timelines and rapid release requirements.

 

Knowledge of International Society for Pharmaceutical Engineering (ISPE) standards preferred, as well as advanced degree and American Society of Quality (ASQ) certification. 

 

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.  Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment.  Under federal law, only truthful information may be provided on the Form I-9.

Benefits

• Medical, dental, and vision insurance
• Healthcare Flex Spending Account (FSA) and Dependent Care FSA
• Company-paid short-term and long-term disability
• Company-paid life insurance & AD&D coverage
• Pet insurance
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• Bonus plan
• Equity Incentive Program

Working Conditions

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:

• Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors
• Noise levels range from quiet to loud, depending on the work area
• Specific vision abilities, including near vision, visual acuity, and color discrimination

Personal Protective Equipment (PPE) is required and may include:

• Respirators, gloves, safety glasses, and full protective clothing
• Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)
• Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions

As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:

• Follow strict radiation safety procedures
• Participate in dosimetry monitoring and bioassay testing as part of the company protocol
• Inform leadership of any health conditions that may affect product integrity, by cleanroom standards

Location

NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.

Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you’re drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families considering relocation.