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Reporting:

Director QA, Sterility Assurance

Description:

We are seeking an experienced Validation Manger, Quality Assurance to join Mariana's Quality Assurance organization, advancing personalized medicine and radiopharmaceuticals. 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. This includes directing validation of production equipment, utility systems, analytical instruments and associated computerized systems, as well as providing QA oversight throughout facility commissioning, startup, and day-to-day management. The Validation Manager, Quality Assurance ensures all validation lifecycle activities comply with global regulatory requirements for radiopharmaceuticals, sterile manufacturing, and radiationcontrolled operations. This role partners closely with Manufacturing Sciences & Technology, Manufacturing, QC, Sterility Assurance, and R&D Operations to ensure the facility is designed, qualified, and validated to support safe, compliant production of radioligand therapies.

Illustrative Breadth of Responsibilities:

Manufacturing Equipment, Analytical Instrument, & Utility Qualification

• Lead QA approval and oversight of qualification activities for GMP manufacturing equipment including:
  • Radiochemistry synthesis modules
  • Hot cells, isolators, and shielding systems
  • Automated dispensing and filling systems
  • Sterile filtration and aseptic processing equipment
  • HEPA/ventilation, HVAC, and radiation containment systems
  • Critical utilities (WFI, compressed gases, Environmental Monitoring /Building Management Systems-EMS/BMS)

• Provide QA oversight for qualification/validation of QC laboratory equipment and analytical instruments, including radioHPLC, GC, gamma spectroscopy equipment, dose calibrators, microbiological systems, and balances
• Ensure testing (IQ/OQ/PQ) is riskbased, traceable to requirements, and aligned with applicable GxP and radiation safety guidelines

Computerized System Validation (CSV)

• Oversee validation of computerized and automated systems supporting manufacturing and QC (e.g., HPLC/GC software, LIMS, EMS, manufacturing execution systems, synthesis/automation software, asset management systems)
• Ensure compliance with 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ALCOA+
• Ensure data integrity of all GxP data generated

Site Commissioning & StartUp

• Provide QA oversight during facility design, commissioning, FAT/SAT execution, and GMP readiness activities for a new radioligand manufacturing facility
• Review and approve commissioning plans, engineering deliverables, and qualification protocols to ensure alignment with GMP and radiation safety requirements
• Support implementation of a qualification and validation strategy integrated with project timelines, construction milestones, and technology transfer activities

Validation Program Ownership

• Collaborate with Manufacturing Sciences & Technology to maintain the site Master Validation Plan (MVP) covering equipment, utilities, analytical instruments, facility qualification, and computerized systems
• Review and approve validation plans, risk assessments, protocols, reports, deviations, and change controls

• Ensure timely and compliant lifecycle documentation throughout design, qualification, and operational states
• Proficiency with riskbased validation approaches and validation lifecycle management

• Prepare for and support regulatory inspections, providing validation subjectmatter expertise

CrossFunctional Leadership

• Collaborate with Manufacturing Sciences & Technology, Manufacturing, QC, and Sterility Assurance, to ensure qualification and validation activities are executed with quality oversight
• Participate in technology transfer, process introduction, and scaleup activities related to new RLT products

• Develop training programs, workflows, and best practices for validation activities across the site
• Strong leadership, communication, and organizational abilities
• Ability to manage complexity, multiple stakeholders, and fastpaced project timelines

Requirements/Skills:

• Position is a hybrid role with 4 days a week attendance required in the Watertown manufacturing facility to perform onsite QA activities related to cGMP manufacturing and quality control testing
• 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
• Experience with working in and implementing a global QMS adhering to EU GMP Vol 4 Part I, IV, and applicable EU GMP Annexes (including but not limited to Annex 1 and Annex 3), 21 CFR 210-212, 21CFR Part 11, ICH, and USP requirements
• 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
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements

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.

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.

US-based eligible employees will receive a comprehensive benefits package that includes a strong health insurance package, life insurance, disability benefits, a 401(k) with company contribution and match, tuition reimbursement, and a variety of other benefits. In addition, employees are eligible for a generous flexible time off program.