Position Summary:

The Associate Director, GxP Systems will report to the Sr. Director, Commercialization Systems and will be responsible for leading the implementation, validation, and support of GxP-regulated systems to enable Quality Assurance, Regulatory, Clinical, and Process Development & Manufacturing (PD&M) in a commercial biotech environment. This role will play a pivotal part in supporting regulatory, compliance, and for commercialization. Working with Quality Assurance, Medical Affairs, Regulatory Affairs, Clinical Operations, and PD&M functions to ensure systems are fit-for-purpose, validated and aligned with evolving business requirements.

Responsibilities:

• Serve as the System Owner and hands-on administrator for GxP systems (e.g., TraceLink, Lorenz DocuBridge, Egnyte Life Sciences, ZenQMS, Global Vision, Veeva), overseeing system lifecycle, performance, and compliance
• Participate in system implementation activities, including vendor selection, requirements gathering, testing, and deployment to ensure alignment with business and regulatory needs
• Provide oversight and direction for Computer System Validation (CSV) activities and validation documentation, partnering with the Validation Engineer to ensure regulatory compliance and audit readiness
• Own and lead Change Control processes for all GxP systems, including impact assessments, risk evaluations, documentation, coordination of testing, and release management
• Perform system administration activities, including user access provisioning, role management, periodic access reviews, and audit trail monitoring
• Oversee system maintenance, enhancements, and issue resolution (e.g., upgrades, patches, changes), ensuring appropriate validation impact assessments, documentation updates, and minimal business disruption
• Collaborate with IT and vendors to support integration, system performance optimization, and resolution of technical issues
• Develop and maintain system-related documentation, including SOPs, Systems Inventory, administrative procedures, and work instructions in collaboration with Quality Assurance and business stakeholders
• Provide SME support during FDA audits and inspections, including preparation, documentation review, and representation of system controls and validation status
• Drive continuous improvement by identifying gaps, inefficiencies, and opportunities for system scalability and automation
• Translate business requirements into effective system solutions, acting as a key liaison between business stakeholders and technical teams
• Manage project timelines, risks, and deliverables to ensure successful and compliant execution of system initiatives

Qualifications:

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related field; advanced degree preferred
• 10-12 years of hands-on experience with GxP systems in Life Sciences, including system administration, validation oversight, and operational support
• Proven experience implementing and validating systems such as eQMS, TraceLink, LMS, Validated Documents and Data storage solutions (such as Box for GxP or Egnyte Life Sciences), or ERP systems (e.g., NetSuite, Oracle, SAP) in a GxP-regulated environment
• Strong understanding of CSV, data integrity, Part 11 compliance, and regulatory expectations (FDA, EMA, ICH)
• Experience partnering with validation/CSV resources while maintaining accountability for system compliance and validation outcomes
• Proven experience owning and managing Change Control processes for GxP systems
• Experience supporting pre-commercial biotech organizations transitioning to commercialization
• Ability to balance strategic oversight with hands-on system administration and operational responsibilities
• Strong cross-functional collaboration skills across IT, QA, Regulatory, and Technical Operations
• Experience managing vendors and implementation partners
• Excellent troubleshooting, analytical, and problem-solving skills
• Strong communication skills with the ability to translate technical concepts into business terms and influence stakeholders

PsiQuantum’s mission is to build the first useful quantum computers—machines capable of delivering the breakthroughs the field has long promised. Since our founding in 2016, our singular focus has been to build and deploy million-qubit, fault-tolerant quantum systems. 

Quantum computers harness the laws of quantum mechanics to solve problems that even the most advanced supercomputers or AI systems will never reach. Their impact will span energy, pharmaceuticals, finance, agriculture, transportation, materials, and other foundational industries. 

Our architecture and approach is based on silicon photonics. By leveraging the advanced semiconductor manufacturing industry—including partners like GlobalFoundries—we use the same high-volume processes that already produce billions of chips for telecom and consumer electronics. Photonics offers natural advantages for scale: photons don’t feel heat, are immune to electromagnetic interference, and integrate with existing cryogenic cooling and standard fiber-optic infrastructure. 

In 2024, PsiQuantum announced government-funded projects to support the build-out of our first utility-scale quantum computers in Brisbane, Australia, and Chicago, Illinois. These initiatives reflect a growing recognition that quantum computing will be strategically and economically defining—and that now is the time to scale. 

PsiQuantum also develops the algorithms and software needed to make these systems commercially valuable. Our application, software, and industry teams work directly with leading Fortune 500 companies—including Lockheed Martin, Mercedes-Benz, Boehringer Ingelheim, and Mitsubishi Chemical—to prepare quantum solutions for real-world impact. 

Quantum computing is not an extension of classical computing. It represents a fundamental shift—and a path to mastering challenges that cannot be solved any other way. The potential is enormous, and we have a clear path to make it real. 

Come join us. 

Job Summary:

PsiQuantum is rapidly scaling to build the world's first useful fault-tolerant quantum computer. At the forefront of this effort, we need a motivated physicist/engineer to join our new laboratory in Brisbane and help us test the limits of our beyond-state-of-the-art quantum photonic platform. This role will focus on the validation and high-performance operation of our quantum photonic systems, and the development and validation of related methodology. The successful candidate will be responsible for executing experiments—including data analysis and interpretation—to validate and calibrate quantum computer subsystems to fault-tolerant levels at high cadence. They will also assist with experimental design. They will identify physical processes that limit photonic quantum performance and feedback new understandings to improve designs and operations of future generation of quantum hardware, and new generations of validation methodologies. They will collaborate broadly with design and engineering teams across all of PsiQuantum’s technical disciplines, including optics, quantum optics, photonics, electronics, cryogenics, quantum architecture, and software to understand system performance and inform engineering models.

Responsibilities:

• Be part of a team pushing photonic quantum computing hardware to fault-tolerant quantum performance.
• Development of classical and non-classical measurements and procedures, and execution of these, to validate optical quantum computer systems performance.
• Develop and verify methods for calibration, self-test, and control of novel quantum photonic systems.
• Develop clear and quantitative metrics for quantum performance.
• Work with other teams to ensure that developed, defined, and documented validation objectives fit with the broader company mission and timeframes.
• Develop requirements for the software and electronics teams to implement procedures and manage data.
• Analyse, reduce, and deliver experimental data. Work with other engineering teams to ensure that the data informs engineering models for system performance.
• Debug complex systems and work with other engineering teams to conduct failure analysis and resolve design or manufacturing issues as appropriate.
• Communicate validation outcomes broadly to internal stakeholders and help guide corrective actions.
• Work on-site in the lab in Brisbane, Australia.

Experience/Qualifications:

• Ph.D or equivalent experience in experimental quantum optics/quantum physics, photonic/electrical engineering, or a related field, and a demonstrated track record of delivering high quality research outcomes.
• Demonstrated expertise in the design and execution of complex quantum experiments in a cross-functional environment.
• Broad technical knowledge with ability to dive deep into required technical areas of our systems including hardware, software, controls, precision measurement, photonics, and quantum information.
• Software development for instrumentation, controls, test equipment, and data analysis (python preferred).
• Proven team player with an ability to work effectively across departments, sites, time zones.
• Excellent verbal and written communication skills with an ability to communicate effectively to a variety of audiences including senior leadership and technical experts.
• Demonstrated interest in PsiQuantum’s mission and vision for quantum computing, with an ability to contribute within a fast-paced start-up environment consistent with PsiQuantum’s values of communication, collaboration, respect, results, and challenge.

PsiQuantum provides equal employment opportunity for all applicants and employees. PsiQuantum does not unlawfully discriminate on the basis of race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, gender expression, national origin, ancestry, citizenship, age, physical or mental disability, military or veteran status, marital status, domestic partner status, sexual orientation, genetic information, or any other basis protected by applicable laws.

Note: PsiQuantum will only reach out to you using an official PsiQuantum email address and will never ask you for bank account information as part of the interview process. Please report any suspicious activity to recruiting@psiquantum.com.

We are not accepting unsolicited resumes from employment agencies.