Manager, Quality Control

The Manager, Quality Control (QC) is responsible for developing and implementing the Quality Control analytical methods, procedures, and processes in compliance with Nucleus RadioPharma’s standards, as well as with current good manufacturing cGMP and applicable federal guidelines. This position involves hiring, training, and leading a high performing QC team to support radiopharmaceutical drug manufacturing. Description PRINCIPAL RESPONSIBILITIES: Lead the development and the execution of QC methods for radioactive drug products in a GxP environment, including radio-HPLC, TLC, GC, gamma spectroscopy, endotoxin testing, and pH measurement, etc. Manage and mentor the Quality Control team, including training, coaching, and offering performance and development management; collaborate with HR for staffing team support. Leads and supports the laboratory personnel in daily activities to fulfill client and GMP requirements. Creates, administers and maintains training for the Quality Control team on cGMP guidelines 21 CFR 210, 211, 212 (as applicable). Ensure the QC team is proficient in all relevant analytical and QC testing methods. Serve as Subject Matter Expert for Quality Control testing on site. Communicate customer’s requirements and quality standards to the team, ensuring alignment with client needs. Collaborate with cross-functional teams to achieve organizational goals and implement process improvements. Provide QC input for strategic planning, especially in relation to new product lines. Work with scientific staff to assess the technical feasibility of new product development. Manage the QC budget, including staffing and resource requirements. Write, maintain, and updates necessary Standard Operating Procedures (SOPs), Validation Protocols and Validation Report. Set requirements for raw materials from suppliers and monitor compliance. Oversee product development to identify any deviations from quality standards. Maintain accurate documentation in relation to quality standards and compliance. Address and resolve customer inquiries, including audit findings and complaints, in a timely manner. Drive continuous improvement initiatives within the QC laboratory to enhance testing efficiency, accuracy, and compliance with regulatory requirements. Lead and support interactions with regulatory authorities during inspections and audits, ensuring QC processes comply with all regulatory requirements. 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. Collaborate closely with R&D, Manufacturing, and Regulatory Affairs teams to ensure that quality standards are maintained throughout the product lifecycle. 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 5 years of related experience required. Minimum of 3 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 instruments such as HPLC, GC, and TLC is 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 guidances, etc.) and the ability to apply them based on the phase of the project (GLP, Phase I, PhaseII/III, etc.) required. Writing of technical documents (procedures, records, forms, experimental reports etc.) experience required. Supervisory experience for scientific team experience required. Knowledge of 21 CFR 212 and USP 823 regulatory requirements preferred. Radioactive material handling of gamma, beta and/or alpha emitters in radiological facilities (shielded glove boxes, hot cells etc.) experience preferred. Chemical and radiological laboratory safety (regulatory and best practices) experience 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. 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. Ability 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. 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.