Associate Director, Quality Systems

Mariana Oncology • Watertown, MA

85d

About The Position

We are seeking an experienced Associate Director, Quality Systems to join Mariana’s Quality Assurance organization, advancing personalized medicine and radiopharmaceuticals.

Requirements

• Bachelor’s or Master’s degree in relevant scientific or engineering discipline.
• At least eight years of experience working within Quality Assurance in the pharmaceutical or biotechnology industry.
• Experience working with radiopharmaceuticals and/or oncology will be considered as a plus.
• Experience working in an onsite GMP manufacturing facility is highly preferred.
• Must have experience implementing an electronic Document Management System.
• Strong understanding of industry quality management tools, quality systems.
• Experience navigating large, complex pharmaceutical organization(s) is preferred.
• System integration experience and/or company integration experience is highly preferred.
• Must be willing to work onsite in Watertown 4 days per week.

Responsibilities

• Lead the integration from Mariana’s legacy QMS to Novartis’ QMS platform.
• Be the system owner and Subject Matter Expert for quality systems (EDMS, EQMS, LMS) at Mariana.
• Review GMP documentation to support the Quality Systems including Document Management, Change Control, Deviations, CAPA, Supplier Management, Risk, and Audits.
• Collaborate cross-functionally, including but not limited to liaising with QA, Regulatory Affairs, CMC, Preclinical Development, Manufacturing, etc.
• Liaise between IT and Operations for QMS process/system enhancements and process improvements.
• Author, review, and, when appropriate, approve policies, procedures, and other related documents for the QMS processes.
• Lead the implementation and/or evolution and execution of QMS GxP training program.
• Manage GxP document archive.
• Manage internal and external audit documentation, while acting as an SME for electronic QMS.
• Establish and/or refine systems governance KPIs and create a culture of continuous improvement.

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 11-50 employees