Senior Manager, Development Quality

Telix Pharmaceuticals (AMER); Deutschland; Hybrid; EUR 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Equity incentive

Annual bonus

Generous vacation

Wellness days

Learning & development support

Zusammenfassung

Telix Pharmaceuticals seeks a Senior Manager, Development Quality to lead GMP oversight of radiopharmaceutical programs and manage CDMO/CMO quality actions. You will drive CAPAs, change controls, and batch release activities, ensuring regulatory readiness across IND/CTA stages.

You will mentor junior staff, provide expert QMS guidance, and partner with cross‑functional teams to scale quality processes across multiple country jurisdictions.

Qualifikationen

• BS/BSc in a science-related discipline is required or higher.
• Advanced degree (MS or PharmD) preferred for senior scope.
• Direct radiopharmaceutical GMP quality experience is essential.
• Experience with CDMO/CMO oversight and batch release processes.

Aufgaben

• Lead GMP compliance oversight for radiopharmaceutical development programs with CDMOs/CMOs.
• Own and improve the Development Quality MSA/QMS processes and documents.
• Provide senior guidance on PQS requirements to cross-functional teams.
• Lead batch release reviews and regulatory documentation for IND/CTA.
• Author/review deviations, investigations, CAPAs, and change controls.
• Mentor junior staff and oversee vendor audits with external partners.
• Represent Development Quality in program governance and risk discussions.

Kenntnisse

GMP knowledge

Quality leadership

Auditing

Regulatory compliance

CAPA & investigations

Vendor management

Cross-functional collaboration

Risk management

Ausbildung

BS/BSc in science

MS/PharmD preferred

Tools

QMS (PQS)

Jobbeschreibung

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll‑out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical‑stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

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. This role leads the execution of quality management system processes — including deviation management, CAPA, change control, and batch record review — and functions as a primary quality interface with external manufacturing partners. The Senior Manager brings deep radiopharmaceutical GMP expertise, exercises independent judgment on complex quality issues, and provides guidance and mentorship to junior quality team members. As the organization transitions from PET diagnostics into radiopharmaceutical therapeutics, this role plays a key part in building scalable quality processes and supporting IND‑stage program needs across multiple country jurisdictions.

Key Accountabilities:

• Good Manufacturing Practices
  • 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.
• Quality Management Systems in Manufacturing
  • 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
• Quality Assurance and Control
  • 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 elevate risk‑based recommendations to the Director, Development
• Regulatory Compliance
  • Demonstrate expert‑level knowledge of radiopharmaceutical GMP requirements including PIC/S GMP, ICH guidelines, 21 CFR 210, 211, and 212, and USP <821>; provide interpretive guidance to teams and support regulatory submission quality inputs (IND/CTA Module 3).
• Documentation 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.

Education and Experience

• 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 <821>, 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 <821>; 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.

Key Capabilities:

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results‑oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts , we strive to be extraordinary , and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance‑based bonuses, an equity‑based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.