Senior Director, Quality Assurance

POSITION SUMMARY

The Senior Director, Quality Assurance leads the Quality function at Nucleus RadioPharma’s Rochester facility and serves as the site’s senior Quality authority. This hands-on leader provides independent oversight of Quality Assurance, sterility assurance, laboratory operations, batch disposition, and inspection readiness for clinical and future commercial radiopharmaceutical manufacturing.

As a member of the Rochester Site Leadership Team, the Senior Director brings a strong and independent Quality perspective to site priorities, operational decisions, risk assessments, and resource planning. This leader is expected to make timely, risk-based decisions, communicate expectations clearly, challenge decisions when necessary, and take decisive action when patient safety, product quality, data integrity, or cGMP compliance may be at risk. Schedule, cost, or customer pressure must never override Quality requirements.

The Senior Director is also accountable for building a culture in which Quality is understood as a shared responsibility and consistently reflected in how work is planned, performed, documented, reviewed, and improved. Through a visible presence on the manufacturing floor and in the laboratories, this leader models integrity, transparency, sound judgment, and accountability; coach's leaders and employees in Quality expectations; reinforces the right behaviors; addresses gaps directly; and ensures Quality principles are embedded in daily decisions and operations across the Rochester site.

PRINCIPAL RESPONSIBILITIES

• Lead the Rochester QA organization as the site's primary Quality decision-maker, defining the QA operating model, staffing, escalation paths, and interfaces with QC, Operations, MSAT, Engineering, Validation, Regulatory Affairs, and Supply Chain.
• Exercise independent authority to approve or reject components, materials, procedures, investigations, validation conclusions, and product batches, and to pause manufacturing, testing, release, or distribution when patient safety, data integrity, or compliance may be compromised.
• Provide end-to-end QA oversight of cGMP operations, material receipt and release, aseptic processing, radiolabeling, sterile filtration and filling, packaging, and laboratory operations: ensuring executed records are complete and reviewed prior to disposition.
• Own the performance and continuous improvement of Quality systems, including deviations, investigations, CAPAs, change control, complaints, recalls, document control, training, supplier quality, and the eQMS, driving fact-based and timely resolution of Quality events.
• Establish and lead Rochester's year-round inspection and audit readiness program, including a risk-based annual audit plan, mock inspections, and a current inspection-readiness playbook.
• Serve as the senior Rochester Quality representative for customer and sponsor audits and FDA and other health authority inspections. Lead audit preparation, inspection hosting, response development, corrective action commitments, and timely, verified closure of all observations in a highly collaborative and transparent culture.
• Serve as the senior Rochester Quality partner for clients, leading input to Quality Agreements and providing QA leadership for technology transfer, process and cleaning validation, stability, and clinical-to-commercial launch readiness.
• Define Rochester's Quality roadmap and represent an independent Quality perspective as an active member of the Rochester Site Leadership Team, providing concise executive visibility into Quality performance, risk, and decisions required.
• Build a technically strong QA team through frequent coaching, candid feedback, and succession planning, and reinforce a Quality culture where employees are expected to speak up, stop work, and escalate without fear of retaliation.
• Set annual QA objectives and key results, inspection-readiness priorities, staffing and succession plans, and a risk-based QA budget aligned with Rochester's clinical and future commercial commitments.
• Perform other general duties as assigned or directed by supervisors.

QUALIFICATIONS & REQUIREMENTS

Required:

• Bachelor's degree in pharmacy, chemistry, microbiology, biology, biochemistry, engineering, or a related scientific discipline, or equivalent.
• Minimum 12 years of progressive Quality experience supporting cGMP drug manufacturing, including at least 10 years direct leadership and 5 years in a senior site Quality leadership role.
• Demonstrated success as a senior Quality leader in a manufacturing site, with accountability for operational QA, Quality systems, product disposition, inspection readiness, and cross-functional decision-making.
• Substantial experience supporting sterile drug manufacturing, aseptic processing, contamination control, and microbiology/environmental monitoring programs, including batch release.
• Demonstrated success hosting multiple FDA or comparable health authority inspections and leading sponsor or customer audits, including front-room leadership and sustained closure of commitments.
• Expert working knowledge of applicable US CGMP requirements, including 21 CFR Parts 210, 211, 212, and 11, with a strong understanding of ICH Quality guidance, data integrity, and phase-appropriate clinical-to-commercial expectations.
• Ability to operate effectively in a radiation-controlled, short-shelf-life manufacturing environment.
• Visible and decisive leadership with sound judgment, courage to escalate, executive presence, and demonstrated ability to change Quality culture in a complex operating environment.
• Excellent verbal and written communication skills.
• Demonstrated problem-solving and interpersonal skills, utilizing resourceful thinking and strong empathy.
• Ability to foster an inclusive and cooperative work environment.
• Ability to work onsite in Rochester, Minnesota, maintain a visible presence across manufacturing, laboratory, warehouse, and office areas, and enter controlled areas in compliance with gowning, PPE, and radiation safety requirements.
• Ability to support business-critical operations outside standard working hours when required, travel occasionally for regulatory, customer, or supplier activities, and lift or move up to 30 pounds occasionally, with or without reasonable accommodation.

Preferred:

• Advanced scientific or technical degree.
• Direct radiopharmaceutical, radioligand therapy, PET drug, or nuclear pharmacy manufacturing experience.
• Annex 1 experience.

Ideal:

• Experience in a CDMO, multi-product, startup, or rapidly scaling site.
• Experience implementing or optimizing eQMS and learning systems.

COMPENSATION & BENEFITS

The salary range for this role is $190,000-250,000k USD per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, and experience.

Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation assistance is available to qualified team members.

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.