Quality Assurance, CQV Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee Quality Assurance for commissioning, qualification, validation, and operational readiness activities throughout the Telix Manufacturing Solution network.

• Review and authorize validation lifecycle documents, such as Validation Master Plans (VMPs), risk assessments, protocols, reports, and qualification documentation.

• Ensure that facility startup, expansion, and remediation efforts align with relevant cGMP requirements.

• Implement risk-based methodologies in commissioning, qualification, and validation.

• Assist in the rollout of quality systems, procedures, and governance to facilitate the transition to standard GMP operations.

• Review and approve deviations, investigations, CAPAs, change controls, and quality risk assessments pertaining to CQV.

• Foster a culture of data integrity, quality, and GMP compliance.

• Collaborate with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs teams.

• Track project milestones, validation outputs, and site-readiness indicators; escalate compliance risks as necessary.

• Aid in technology transfers, manufacturing preparedness, site activation, and the transition to on-site Quality Assurance and Quality Control teams.

• Direct readiness preparations for regulatory audits and internal or customer inspections.

• Coordinate and oversee contractors, validation consultants, engineering firms, and service providers engaged in CQV activities.

• Support facility construction and expansion, equipment and utility qualification, computerized systems validation, process validation, and operational readiness.

• Report to the Quality Director for Manufacturing Expansion & Readiness.

• Engage in extensive travel throughout the U.S. Telix Manufacturing Solution network, with travel likely exceeding 75% and potential multi-week site assignments.

⛳️ Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Engineering, Microbiology, Life Sciences, or a related scientific field is required.

• A minimum of 5 years of experience in Quality Assurance, Validation, Engineering Quality, or CQV within the pharmaceutical, biotechnology, or radiopharmaceutical sectors.

• At least 5 years of hands-on experience supporting Commissioning, Qualification, and Validation (CQV) efforts for GMP facilities and manufacturing systems.

• Proficient in reviewing and approving Validation Master Plans (VMPs), User Requirement Specifications (URS), Design Qualification (DQ), IQ/OQ/PQ protocols, risk assessments, and validation reports.

• Technical knowledge of manufacturing, quality, and regulatory standards.

• Experience in writing and reviewing Standard Operating Procedures (SOPs).

• Willingness and capability to travel over 75% across various U.S. manufacturing locations, including potential extended stays of several weeks.

• Proficiency in English.

• Understanding of applicable cGMP regulations, including 21 CFR Parts 210, 211, and 212.

• Ability to handle validation documentation, quality systems, risk management, deviations, investigations, CAPAs, and change controls effectively.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for professional learning and development.

• Options for hybrid and remote work arrangements available across the organization.