Quality Assurance, CQV lead

 

See Yourself at Telix

The Quality Assurance Commissioning, Qualification, and Validation (CQV) Lead is a highly mobile, site-based role requiring extensive travel across the Telix Manufacturing Solution (TMS) network in the United States. Reporting to the Quality Director, Manufacturing Expansion & Readiness, the role provides Quality Assurance support and oversight for facility construction and expansion, equipment and utility qualification, computerized systems validation, process validation, and operational readiness.

Travel is expected to exceed 75% and may require extended stays of several weeks at a site, depending on project schedules, validation timelines, and readiness milestones. The role partners with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs to ensure CQV activities meet applicable cGMP requirements and Telix Quality Systems.

The position will support the implementation of quality oversight, validation strategies, risk management practices, documentation, and inspection-readiness activities needed to transition sites from project execution to routine GMP operations and support clinical and commercial manufacturing.

Key Accountabilities:

CQV & Quality Oversight

Provide Quality Assurance oversight for CQV and operational readiness activities across the TMS network.

• Review and approve validation lifecycle documentation, including VMPs, risk assessments, protocols, reports, and qualification
• Ensure facility startup, expansion, and remediation activities comply with applicable cGMP requirements, including 21 CFR Parts 210, 211, and 212, as relevant to the site.
• Apply risk-based approaches to commissioning, qualification, and validation

Quality Systems & Compliance

Support the implementation of quality systems, procedures, and governance needed to transition facilities into routine GMP operations.

• Review and approve deviations, investigations, CAPAs, change controls, and quality risk assessments related to CQV Contribute to consistency and compliance of qualification and validation practices at assigned sites.
• Promote data integrity, quality culture, and GMP compliance throughout project execution and routine

Project Readiness & Collaboration

• Partner with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs to support project execution and GMP readiness.
• Monitor project milestones, validation deliverables, and site-readiness metrics; escalate compliance risks and execution
• Support technology transfers, manufacturing readiness, site activation, and the handoff to on-site Quality Assurance and Quality Control teams.

Contractor & On-Site Support

Lead readiness activities for regulatory inspections and internal or customer audits related to facility startup and validation. Coordinate and monitor contractors, validation consultants, engineering firms, and service providers supporting CQV activities

Education and Experience:

• Bachelor’s degree required. Orientation in Pharmacy, Chemistry, Biochemistry, Engineering, Microbiology, Life Sciences, or a related scientific discipline. Advanced degree is desirable.,
• 5 years of experience in Quality Assurance, Validation, Engineering Quality, or CQV within the pharmaceutical, biotechnology or radiopharmaceutical industry.
• Minimum 5 years of direct experience supporting Commissioning, Qualification, and Validation (CQV) activities for GMP facilities and manufacturing systems.
• Experience reviewing and approving Validation Master Plans (VMPs), User Requirement Specifications (URS), Design Qualification (DQ), IQ/OQ/PQ protocols, risk assessments, and validation reports.
• Technical understanding of manufacturing, quality and regulatory requirements,
• Previous experience writing and reviewing with understanding SOPs,
• Willingness and ability to travel more than 75% across multiple S. manufacturing sites, including extended stays of several weeks, based on project schedules and validation timelines.
• Languages: English 

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