Associate Director, MS&T Compliance

Reporting:

Director, Manufacturing Science & Technology

Description:

We are seeking an experienced Associate Director, MS&T Compliance to join Mariana’s Manufacturing Science & Technology organization, advancing personalized medicine and radiopharmaceuticals. This role will provide leadership in compliance for manufacturing activities, with a strong focus on deviation investigations, change management, root cause analysis, and inspection readiness. The Associate Director will serve as a subject matter expert in cGMP manufacturing compliance, ensuring operational excellence, continuous improvement, and alignment with regulatory expectations in the radiopharmaceutical sector. This position will also manage compliance-related projects and act as the primary MS&T representative in interactions with Quality functions.

Illustrative Breadth of Responsibilities:

• Lead and oversee investigation activities for deviations, including coordination of cross-functional teams and impact assessments.
• Develop and author change controls, deviation reports, root cause analyses, corrective and preventive action (CAPA) plans, and other compliance documentation.
• Drive the timely closure of investigations, CAPAs, and change controls in close collaboration with Quality and MS&T leadership.
• Manage ongoing MS&T compliance projects to ensure alignment with quality and regulatory requirements, while driving continuous improvement initiatives.
• Deliver training to MS&T, Manufacturing, and Support teams on investigation best practices, root cause analysis, and CAPA effectiveness.
• Provide inspection readiness support for both personnel (training, responses, mock inspections) and facilities (equipment, documentation, and cleanliness).
• Identify compliance risks within GMP manufacturing operations and recommend process improvements aligned with Right-First-Time principles.
• Support and execute risk assessments, gap analyses, and compliance-focused operational reviews.
• Serve as the MS&T compliance representative during audits, inspections, and management review presentations.
• Act as the key liaison between MS&T and local/parent company Quality Assurance functions, ensuring alignment on compliance priorities, strategies, and execution.
• Partner with cross-functional teams to strengthen operational and regulatory compliance across MS&T activities.
• Other duties as assigned.

Requirements/Skills:

• Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• 8+ years of experience in MS&T, Process Development, or Manufacturing within the pharmaceutical, biotechnology, or radiopharmaceutical industry.
• Strong expertise in deviation management, CAPA systems, change control processes, and GMP compliance frameworks.
• Working knowledge of bioprocessing workflows including upstream, downstream, and analytical operations.
• Demonstrated ability to analyze complex technical data and drive data-based decision-making.
• Strong scientific and engineering aptitude with proven problem-solving and compliance investigation skills.
• Excellent written and verbal communication, including the ability to present to auditors, inspectors, and senior leadership.
• Proven track record in training and developing technical staff in compliance and investigation best practices.
• Experience with electronic quality management systems (e.g., Veeva), ERP platforms, and statistical tools (e.g., JMP, SIMCA) strongly preferred.
• In-depth understanding of regulatory requirements (FDA, EMA, ICH) in a GMP manufacturing environment.

Mariana Oncology’s Principles

• Building a Legacy
• Execution Excellence
• Courage of our Convictions