Director Clinical Quality Jobs in Rochester, MN (NOW HIRING)

The Director, Quality Control provides strategic and operational leadership for the Quality Control organization supporting analytical testing, microbiology, sterility assurance, environmental monitoring, laboratory operations, and product release activities across clinical and future commercial radiopharmaceutical manufacturing.

This leader is responsible for building and continuously evolving a high-performing, inspection-ready Quality Control organization capable of supporting rapid organizational growth, technology transfers, process validation, commercial manufacturing, and a nationally distributed manufacturing network. The Director establishes scalable laboratory systems, develops exceptional talent, and creates a culture of quality, accountability, operational excellence, and continuous improvement.

As a key member of the Site Leadership Team and Quality Leadership Team, the Director partners closely with LABS (R&D), Manufacturing, MSAT, Engineering, Supply Chain, and Quality Assurance to ensure compliant, efficient, and reliable laboratory operations that enable safe, timely delivery of life-changing therapies to patients.

The successful candidate demonstrates the ability to develop long-term laboratory strategy, coach and develop leaders, driving operational performance, and remain actively engaged in solving complex technical and organizational challenges within a fast-paced, high-growth environment.

Quality Control Strategy and Leadership

• Develop and execute the Quality Control strategy aligned with business objectives, growth plans, and operational excellence.
• Establish organizational structure, succession planning, workforce planning, and talent development strategies.
• Develop and manage departmental budgets, capital planning, resource allocation, and staffing strategies.
• Establish departmental OKRs, goals, KPIs, and laboratory performance and quality metrics to drive accountability, operational performance, and continuous improvement.
• Develop long-term laboratory expansion strategies that support the future manufacturing network and business growth.
• Hold leaders and employees accountable for maintaining a safe, compliant, highly organized, and professional laboratory environment.
• Partner with Quality Assurance, Manufacturing, LABS (R&D), MSAT, Engineering, and other functional leaders to align Quality Control priorities with operational, client, and business objectives.

Technical Leadership and Guidance

• Serve as the site's Quality Control technical expert.
• Provide scientific leadership and technical decision-making across analytical chemistry, microbiology, sterility assurance, and environmental monitoring.
• Provide technical guidance and Quality Control oversight for analytical method qualification, transfer, validation, verification, and lifecycle management, while partnering with LABS (R&D) on analytical method development activities.
• Lead technical investigations involving analytical methods, laboratory systems, instrumentation, data integrity, and product quality.
• Assess Quality Control testing strategies, analytical readiness, and laboratory requirements for new customer programs, technology transfers, process validation, and commercial readiness.
• Identify and drive implementation of new analytical technologies, laboratory automation, and digital solutions that improve laboratory capability, efficiency, data integrity, and operational performance.

Laboratory Operations & Execution

• Provide strategic and operational oversight for Analytical Chemistry, Microbiology, Sterility Assurance, Environmental Monitoring, and laboratory support functions.
• Provide oversight of microbiology and sterility assurance laboratories.
• Ensure timely laboratory testing and product release activities.
• Ensure timely testing and release activities supporting client commitments.
• Oversee laboratory scheduling, capacity planning, workflow optimization, and resource utilization.
• Oversee laboratory scheduling and capacity planning.
• Optimize laboratory workflows.
• Ensure laboratory equipment, instrumentation, computerized systems, and facilities remain qualified, calibrated, maintained, and inspection ready.
• Ensure laboratory equipment qualification, calibration, and maintenance.
• Utilize performance metrics and data analytics to optimize throughput, quality, efficiency, and customer service.

Compliance, Inspection Readiness & Quality Systems

• Ensure Quality Control laboratory operations comply with applicable GMP requirements, including FDA 21 CFR Parts 210, 211, and 212, USP, ICH, data integrity requirements, and applicable international regulatory expectations.
• Maintain inspection-ready laboratory operations.
• Lead laboratory activities during regulatory inspections, customer audits, and third-party assessments.
• Lead regulatory inspections involving QC.
• Support customer audits.
• Maintain a continuous state of inspection readiness.
• Provide leadership and oversight for laboratory deviations, OOS/OOT events, CAPAs, change controls, root cause investigations, and other quality events, ensuring timely resolution and effective corrective and preventive actions.

Cross-Functional Support

• Partner with Manufacturing, MSAT, Engineering, Regulatory Affairs, and Quality Assurance to solve complex technical challenges and support product lifecycle management.
• Provide Quality Control support for new client proposals and technical due diligence.
• Support technology transfer activities.
• Evaluate analytical feasibility for new products.
• Participate in client meetings.
• Support process validation and commercial readiness activities.
• Evaluate analytical strategies for technology transfers and commercial readiness.

Continuous Improvement & Operational Excellence

• Champion Operational Excellence through Lean Laboratory principles, 5S, visual management, standard work, and continuous improvement initiatives.
• Build and sustain laboratories that are safe, inspection ready, organized, efficient, and reflective of leading GMP operations laboratory practices.
• Drive implementation of laboratory automation and digital technologies that improve efficiency and quality.
• Utilize data analytics, performance metrics, and continuous improvement tools to optimize laboratory quality, efficiency, throughput, and customer service.

• Bachelor’s degree in chemistry, Pharmaceutical Sciences, Biology, or related scientific discipline required; advanced degree (Master's or Ph.D.) in Chemistry or a related scientific discipline preferred.
• Minimum of 10 years of progressive experience in Quality Control, Analytical Development, and/or CMC functions within the pharmaceutical, biotechnology, CDMO, or radiopharmaceutical industry.
• Minimum of 5 years of experience in a leadership capacity directing or managing Quality Control, Analytical Development, and/or laboratory operations teams.
• Experience supporting regulatory inspections, audits, and agency interactions involving FDA and/or other health authorities.
• Experience supporting analytical method development, validation, and technology transfer.
• Experience building and scaling laboratory organizations in a GMP environment preferred.

• Strong leadership and organizational development skills with demonstrated ability to build and lead high-performing teams.
• Demonstrated ability to lead multiple strategic initiatives and complex cross-functional projects within fast-paced startup and CDMO environments.
• Exceptional communication and influencing skills with the ability to effectively engage regulatory authorities, clients, auditors, cross-functional leaders, and executive leadership.
• Ability to effectively communicate with regulatory authorities, clients, auditors, and executive leadership.
• Demonstrated ability to drive operational excellence, Lean continuous improvement initiatives, and organizational performance through data-driven decision making.
• High attention to detail and commitment to quality and compliance.
• Demonstrated ability to develop departmental strategy, manage budgets, prioritize capital investments, and align resources with organizational objectives.
• Adaptable to changing priorities and organizational growth.
• Ability to foster an inclusive, collaborative, and accountable work environment.
• Demonstrated strategic, analytical, and critical thinking skills with the ability to evaluate complex issues, develop risk-based solutions, and make sound business decisions.
• Ability to work sitting and standing for extended periods, including grasping/gripping and fine motor control activities.
• Ability to lift, move, transport, and position equipment and work items weighing up to 30 pounds on a frequent basis.
• Ability to work in cleanroom and radiopharmaceutical manufacturing environments while adhering to gowning, hygiene, radiation safety, and contamination control requirements.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.