Senior Manager, Quality Assurance (RLT Manufacturing Ops)

Breadth of Responsibilities

Lead the QA RLT Operations team.
Coach and develop QA RLT Operations team members, fostering a culture of quality, accountability, collaboration, and continuous improvement.
Serve as a subject matter expert (SME) in radiopharmaceutical GMP requirements, aseptic operations, and radiation-handling quality considerations.
Train manufacturing and QC personnel on quality systems, deviations, and compliance standards.
Support GMP training program by creating and delivering Operations QA training modules.
Perform QA support for radioligand manufacturing, including aseptic processing, sterile filtration, radiolabeling, and final product packaging.
Lead QA oversight for product lifecycle activities, technology transfer, process qualification and validation activities, process changes, and new product introductions.
Review technology transfer, process validation, manufacturing process risk analysis, product stability, and other types of technical reports to support IND and global regulatory submissions.
Support GMP training program by creating and delivering Operations QA training modules.
Ensure adherence to GMP, ALCOA+ data integrity principles, and radiation safety requirements.
Review and approve master production records.
Review executed batch records, analytical data, specifications, protocols, reports, logbooks, and supporting documentation for radiopharmaceutical intermediates, drug products, and finished products.
Disposition raw materials, components, and finished radioligand batches.
Review, approve, and drive timely resolution of quality events, including investigations related to deviations, OOS/OOT results, and complaints.
Review and Approve CAPAs, change controls, and risk assessments.
Maintain GMP documentation and controlled forms. Draft QA Operations SOPs.
Review and approve quality assurance, manufacturing, and quality control procedures.
Prepare for and support internal audits, regulatory inspections (e.g., FDA, EMA, ICH), and corporate quality assessments.
Ensure manufacturing areas remain in a state of compliance and inspection readiness.
Identify and drive improvements in processes, documentation, and compliance across radioligand operations.
Support implementation of new equipment, facility upgrades, and process changes.
Identify systemic issues and lead initiatives to improve right first-time performance, compliance, and operational efficiency.
Promote a strong quality and safety culture with emphasis on radiological safety and GMP rigor.

Requirements/Skills

• Bachelor’s or Master’s degree in relevant scientific or engineering discipline with at least ten years of experience working within Quality Assurance in the pharmaceutical or biotechnology industry.
• Experience working with radiopharmaceuticals and/or oncology will be considered as a plus.
• Experience with working in and implementing a global QMS adhering to EU GMP Vol 4 Part I, IV, and applicable EU GMP Annexes (including but not limited to Annex 1 and Annex 3), 21 CFR 210-212, 21CFR Part 11, ICH, and USP requirements.
• Experience supporting aseptic operations, isotopes/radioligands, or PET/SPECT radiopharmaceutical environments preferred.
• Ability to work collaboratively with cross functional teams including manufacturing, quality control, supply chain, technical development, and facilities personnel.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.