Mariana Oncology
Validation Manager, Quality Assurance
Watertown, Massachusetts · Director
Sponsorship not specifiedDetected 44 days ago
Pharmacy PracticeGMPMass SpectrometryLeadershipCommunicationGxP
About the role
- The Validation Manager, Quality Assurance is responsible for leading and overseeing the qualification and validation program supporting existing and new cGMP radioligand therapy (RLT) manufacturing facilities.
- The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and will be reviewed periodically upon joining Mariana Oncology.
- Mariana may change the published salary range based on company and market factors.
Responsibilities
- Lead QA approval and oversight of qualification activities for
- Critical utilities (WFI, compressed gases, Environmental Monitoring /Building Management Systems-EMS/BMS)
- Provide QA oversight during facility design, commissioning, FAT/SAT execution, and GMP readiness activities for a new radioligand manufacturing facility
- Support implementation of a qualification and validation strategy integrated with project timelines, construction milestones, and technology transfer activities
- Collaborate with Manufacturing Sciences & Technology to maintain the site Master Validation Plan (MVP) covering equipment, utilities, analytical instruments, facility qualification, and computerized systems
- Ensure timely and compliant lifecycle documentation throughout design, qualification, and operational states
- Prepare for and support regulatory inspections, providing validation subject‑matter expertise
- Collaborate with Manufacturing Sciences & Technology, Manufacturing, QC, and Sterility Assurance, to ensure qualification and validation activities are executed with quality oversight
- Develop training programs, workflows, and best practices for validation activities across the site
Requirements
- Proficiency with risk‑based validation approaches and validation lifecycle management
Skills
- Bachelor's degree in Engineering, Chemistry, Life Sciences, Pharmacy, or a related technical field
- 3-5+ years of experience in GMP validation or QA roles within biotech or pharma in an aseptic manufacturing environment
- Direct experience commissioning GMP facilities or supporting greenfield/brownfield site startups is strongly preferred
- Demonstrated expertise in equipment qualification, analytical instrument validation, utility qualification, and CSV
- Mariana Oncology's Principles
- Building a Legacy
- Execution Excellence
- Courage of our Convictions
- Mariana Oncology Compensation Summary
- The salary for this position is expected to range between $107,200.00 and $160,800.00 per year.
- Your compensation will also include a performance-based cash incentive.
Compensation
- Mariana Oncology Compensation Summary
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