Senior Manager, Development Quality
About the role
The Senior Manager, Development Quality serves as a senior technical and operational quality leader within the Development Quality function, providing expert oversight of CDMO/CMO quality activities and driving continuous improvement across development-stage radiopharmaceutical programs.
Responsibilities
Lead GMP compliance oversight for radiopharmaceutical development programs manufactured by CDMOs/CMOs, including real-time GMP monitoring, batch disposition support, and proactive identification of compliance risks specific to short half-life manufacturing environments.
Own the preparation, review, and approval of key QMS documents within Telix PQS, and lead cross-functional process improvements to enhance the effectiveness and efficiency of the development-stage quality system.
Provide senior-level guidance to manufacturing, project, and CMC teams on PQS requirements and quality expectations; serve as a subject matter expert on QMS processes for development-stage radiopharmaceutical.
Lead and independently execute batch release activities for investigational radiopharmaceutical products, including review and approval of batch records, QC results, and certificate of analysis documentation from CDMOs/CMOs.
Provide senior review and approval of SOPs, batch records, QC results, and regulatory documents; independently assess compliance gaps and escalate risk-based recommendations to the Director, Development.
Document and Record-Keeping: Lead the authoring, review, and approval of deviations, investigations, CAPAs, and change controls; mentor junior team members on investigation methodology, root cause analysis, and CAPA effectiveness evaluation to build team capability.
People Leadership and Vendor Management: Provide day-to-day guidance, mentorship, and technical oversight to junior Development Quality team members; contribute to onboarding, training development, and performance support within the Lead quality oversight of CDMO/CMO relationships, including conducting or co-leading supplier audits, managing audit observations through closure, and escalating systemic quality risks to the Director, Development Quality.
Represent Development Quality in cross-functional program teams, providing independent quality voice in project governance, risk discussions, and regulatory readiness activities.
Qualifications
BS/BSc or higher in a science-related discipline (e.g., Chemistry, Radiochemistry, Pharmacology, Biology, or related field) required; advanced degree (MS, PharmD) preferred.
8+ years of progressive quality experience within the pharmaceutical, biotechnology, or radiopharmaceutical industry, with demonstrated depth in development-stage GMP quality and CDMO/CMO oversight.
Direct radiopharmaceutical quality experience required, including familiarity with short half-life manufacturing, USP, real-time release testing, and hot-cell or dispensing operations quality oversight.
Demonstrated expertise in independently authoring, reviewing, and approving SOPs, quality plans, and technical quality documents for development-stage programs.
Extensive experience independently reviewing and approving batch records manufactured by CMOs/CDMOs, including radiopharmaceutical or sterile manufacturing batch records.
Expert-level experience leading investigations, root cause analysis, and CAPA management; proven track record of independently authoring, reviewing, and approving complex deviations and change controls.
Applied expertise in quality risk management using ICH Q9 frameworks; ability to independently conduct risk assessments and communicate risk-based recommendations to program teams and senior leadership.
Demonstrated ability to operate as a senior quality representative in matrixed, cross-functional teams; experience influencing external vendor quality performance and driving issue resolution with CDMOs/CMOs.
In-depth understanding of 21 CFR Part 210/211/212, ICH Guidelines (Q7, Q9, Q10), PIC/S GMP, and USP; working knowledge of IND/CTA quality requirements and CTD Module 3 expectations for radiopharmaceutical development.
Radiopharmaceutical industry experience required; PET manufacturing or targeted radiotherapy development quality experience strongly preferred.
Quality auditing experience required, including experience leading or co-leading GMP audits of external manufacturing partners; experience managing audit observations through closure preferred.
Ability to travel (approximately up to 20%) for CDMO/CMO audits, site visits, and regulatory.
Experience mentoring or providing technical oversight to junior quality staff; formal people management experience is a plus but not required for this role.