Senior Manager, Quality Control

About the role

The Senior Manager, Quality Control (QC) provides strategic, technical, and operational leadership for the Quality Control organization supporting radiopharmaceutical development and cGMP manufacturing operations in our Rochester, Minn site.

Responsibilities

• Provide strategic and operational leadership for the Quality Control organization supporting radiopharmaceutical manufacturing and development activities.
• Build, develop, and mentor a high-performing QC team, including recruitment, onboarding, training, coaching, succession planning, and performance management.
• Lead the development, qualification, validation, transfer, and lifecycle management of analytical methods for radioactive drug products in a GxP environment, including radio-HPLC, TLC, GC, gamma spectroscopy, endotoxin testing, pH analysis and other analytical techniques.
• Oversee daily QC laboratory operations to ensure timely and compliant release testing, stability testing, raw material testing, environmental support testing, and client deliverables.
• Establish and maintain phase-appropriate QC systems, procedures, laboratory controls, and programs aligned with 21 CFR Parts 210, 211, and 212, USP requirements, and applicable ICH guidelines.
• Lead laboratory investigations, including Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, CAPAs, and root cause investigations, ensuring robust, scientifically sound, and timely resolution.
• Collaborate cross-functionally with Manufacturing, MSAT, Engineering, Regulatory Affairs, Supply Chain, Radiation Safety, and Quality Assurance to support product lifecycle activities and operational readiness.
• Support technical transfer, client onboarding, and startup activities for new radiopharmaceutical programs and manufacturing processes.
• Drive continuous improvement initiatives within QC operations focused on laboratory efficiency, compliance, data integrity, automation, and right-first-time execution.
• Develop and monitor QC performance metrics and KPIs, including laboratory turnaround times, deviation trends, CAPA effectiveness, and compliance metrics, reporting results to Quality leadership.
• Lead and support regulatory inspections, client audits, and internal audits, including preparation activities, inspection hosting, response development, and CAPA implementation.
• Oversee QC documentation systems, including SOPs, specifications, analytical methods, protocols, reports, logbooks, and training records.
• Ensure QC activities maintain compliance with data integrity requirements and Good Documentation Practices (GDP).
• Support implementation and optimization of electronic laboratory systems, LIMS, Empower, and/or eQMS platforms as applicable.
• Evaluate and implement new analytical technologies, instrumentation, and automation solutions to improve operational performance and laboratory scalability.
• Collaborate closely with R&D, Manufacturing, and Regulatory Affairs teams to ensure that quality standards are maintained throughout the product lifecycle.
• Perform routine quality project management reviews with the quality team and leadership.
• Conduct routine quality project management reviews with the quality team and leadership.
• Identify and implement new technologies and automation tools to improve testing throughput and data accuracy.
• Oversee risk management activities within QC, ensuring that potential risks to product quality are identified, assessed, and mitigated in accordance with regulatory guidelines.
• Perform other duties as assigned.

Qualifications & Requirements

• Bachelor's degree in chemistry or related area required, Master’s degree in chemistry or related area preferred.
• Minimum of 8 years of related experience within a cGMP-regulated pharmaceutical, biotechnology, CDMO, or radiopharmaceutical environment required.
• Minimum of 5 years in a leadership position within cGMP Quality Control pharmaceutical space required; 3 years of experience in leadership position within quality control of cGMP Radiopharmaceuticals preferred.
• Hands-on experience with analytical instrumentation including HPLC, GC, TLC, gamma spectroscopy, endotoxin systems, and related laboratory technologies required.
• Experience working in facilities compliant with ICH Q7, GxPs, 21 CFR 211 and 21 CFR 212 preferred.
• Knowledge of regulations applicable to drugs and devices (21 CFR Parts 210/211, ICH and FDA guidance's, etc.) and the ability to apply them based on the phase of the project (GLP, Phase I, PhaseII/III, etc.) required.
• Writing technical documents (procedures, records, forms, experimental reports etc.) experience required.
• Supervisory experience for scientific team experience is required.

Preferred Qualifications

• Radioactive material handling of gamma, beta and/or alpha emitters in radiological facilities (shielded glove boxes, hot cells etc.) preferred experience.
• Chemical and radiological laboratory safety (regulatory and best practices) preferred.
• Advanced ability to effectively lead one or more projects with competing priorities to meet the demands of a fast-paced and dynamic work environment required.
• Strong technical writing experience including SOPs, protocols, validation reports, investigations, and quality records required.
• Experience implementing continuous improvement initiatives and laboratory operational excellence programs preferred.
• Experience with electronic systems such as LIMS, Empower, TrackWise, Veeva, MasterControl, or equivalent systems preferred.

Knowledge, Skills & Abilities

• Strong leadership and organizational development skills with demonstrated ability to build and lead high-performing teams.
• Demonstrated ability to manage multiple priorities and complex projects within fast-paced startup and CDMO environments.
• Excellent analytical, critical thinking, and problem-solving capabilities.
• Strong interpersonal, communication, and collaboration skills with the ability to influence cross-functional stakeholders.
• Able to effectively communicate with regulatory authorities, clients, auditors, and executive leadership.
• Strong understanding of laboratory compliance, data integrity, contamination control, and GMP documentation practices.
• Demonstrated ability to drive operational excellence and continuous improvement initiatives.
• High attention to detail and commitment to quality and compliance.
• Adaptable to changing priorities and organizational growth.
• Able to foster an inclusive, collaborative, and accountable work environment.
• Ability to work sitting and standing for extended periods, including fine motor control activities.
• Ability to lift/move equipment and materials weighing up to 30 pounds frequently.
• Ability to work in cleanroom and radiopharmaceutical manufacturing environments while adhering to gowning, hygiene, radiation safety, and contamination control requirements.
• Adaptable to quickly changing priorities required.
• In-depth critical thinking skills to evaluate issues and identify a potential solution.
• Creatively addresses complex or new problems required.
• Strong interpersonal and leadership skills, with a focus on teamwork, are required.
• Able to foster an inclusive and cooperative work environment required.
• Ability to work sitting and standing for extended periods, grasping/gripping, fine motor control with hands required.
• Ability to lift / move, transport, position equipment and work items weighing up to 30 pounds across on a frequent basis.

Pay & Benefits

The salary range for this role in Minnesota is $117,000-160,000 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.