Classification: Full Time, Exempt
Work Location: Rochester, MN - Onsite
The Sr. Manager, Quality Assurance (QA) is responsible for providing strategic and operational leadership for the site Quality Assurance program and Quality Management System (QMS) supporting clinical and future commercial radiopharmaceutical manufacturing operations. This role ensures compliance with applicable global regulatory requirements, including 21 CFR Parts 210, 211, and 212, while advancing a culture of quality, inspection readiness, continuous improvement, and operational excellence.
The Senior Manager serves as a key quality leader within the organization and partners cross-functionally with Operations, Engineering, MSAT, Regulatory Affairs, Validation, Supply Chain, and Technology to ensure quality systems and GMP controls are effectively implemented and scalable to support organizational growth.
This role is responsible for driving proactive quality risk management, overseeing critical quality systems, leading regulatory inspection readiness activities, and mentoring a high-performing QA organization capable of supporting a rapidly growing CDMO environment.
- Develop, manage, and maintain continual improvement of QA programs, policies and procedures for pre-clinical, clinical, and commercial radiopharmaceutical drug production.
- Provide strategic leadership for the site Quality Management System (QMS), ensuring scalability, compliance, and alignment with organizational objectives.
- Lead site quality initiatives supporting clinical and future commercial manufacturing readiness.
- Serve as the primary QA lead and site representative during regulatory inspections, customer audits, and quality assessments, providing strategic leadership and coordination for inspection activities and responses.
- Lead site inspection readiness activities, including mock inspections, audit preparation, response coordination, and remediation activities, ensuring a continuous state of regulatory and client audit readiness.
- Strong knowledge of applicable GMP regulations and guidance, including 21 CFR Parts 210, 211, and 212, ICH guidelines, EU GMP Annex 1, and phase-appropriate regulatory expectations for sterile injectable manufacturing.
- Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.
- Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Engineering and Operations team.
- Write, review, approve, and/or implement quality procedures, specifications, processes, and methods as required.
- Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
- Prepare and present periodic review of the quality system for regular ‘Management Review’
- Partner with Operations, Engineering, MSAT, Validation, and Regulatory Affairs to ensure quality and compliance requirements are integrated into facility, equipment, process, and product lifecycle activities.
- Provide quality oversight and risk assessment support for technical transfers, process changes, validation activities, and new product introductions.
- Development, review, and approval of facility, process, and equipment validations
- Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.
- Oversee site quality systems including deviations, CAPAs, change controls, investigations, complaints, supplier quality, training, and document management.
- Ensure effective implementation and optimization of electronic Quality Management Systems (eQMS).
- Establish, monitor, and analyze key quality metrics, trends, and performance indicators (e.g., deviations, CAPAs, environmental monitoring, audit findings) to proactively identify compliance risks and drive continuous improvement initiatives.
- Apply phase-appropriate GMP principles aligned with FDA guidance for clinical manufacturing while maintaining scalable systems to support future commercial readiness.
- Build, mentor, and develop a high-performing QA organization by ensuring team members are appropriately trained, qualified, coached, and developed to support compliance, operational excellence, and future organizational growth.
- Liaise with internal and external inspectors and representatives, particularly on QA-related topics.
- Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).
- Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify management problems in personnel, equipment, and the facility that require correction.
- Review documents associated with the site’s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.
- Ensure the qualification and ongoing performance of critical suppliers and vendors, including conducting periodic audits and reviewing quality agreements.
- Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.
- Implement risk management processes to proactively identify and mitigate potential quality and compliance issues.
- Develop and monitor key quality metrics (e.g., CAPA, audit findings, deviations) and report trends to senior management, recommending corrective actions where needed.
- Ensure compliance with all applicable standard operating procedures and regulations, including 21 CFR Part 210, 211, and 212 requirements.
- Ensure product complaints are managed in a manner consistent with SOPs and FDA regulations.
- Attend quality and operational meetings. Interface with QA and Operations on quality-related issues. Provide status updates as required management.
- Bachelor's Degree (B.S.) in an appropriate scientific or engineering field of study required, preferred fields of study include Microbiology, Biology, Medical Technology, Pharmacy, Biochemistry, or Engineering.
- Minimum 8 years of progressive experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, or radiopharmaceutical manufacturing environment required.
- Minimum 5 years of progressive leadership experience managing QA teams and quality systems in a regulated manufacturing environment required.
- Knowledge of how and ability to write, review, and revise Standard Operating Procedure (SOPs) required.
- Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
- Ability to write reports, business correspondence, and procedure manuals required.
- Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, and inspectors required.
- Ability to define problems, collect data, establish facts, and draw valid conclusions required.
- Ability to solve problems and handle issues required.
- Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.
- Experience leading or directly supporting FDA, EMA, and/or international regulatory inspections required.
- Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.
- Quality, Pharmacy, or CGMP manufacturing experience preferred.
- Experience with Quality by Design (QbD) principles and regulatory interactions/submissions with FDA, EMA, or other global health authorities preferred.
- Proficiency in using continuous improvement methodologies such as Six Sigma, Lean Manufacturing, or Kaizen to drive quality improvements.
- Experience implementing, managing, or optimizing electronic Quality Management Systems (eQMS) such as MasterControl, Veeva, or TrackWise strongly 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. Adaptable to quickly changing priorities.
- In-depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems.
- Ability to foster an inclusive and cooperative work environment.
- Ability to lift / move, transport, position equipment and work items weighing up to 30 pounds across on a frequent basis.
- Experience managing quality systems in startup, CDMO, or rapidly scaling manufacturing environments strongly preferred.
- Extensive experience supporting sterile injectable manufacturing, aseptic processing, contamination control, and Annex 1 expectations preferred.
COMPENSATION & BENEFITS
The salary range for this role in Minnesota is $110,000- 165,000 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.
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
