Associate Director, Quality Systems

Job Description

Job DescriptionSalary:

Reporting:

Vice President, Quality Assurance

Description:

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

Illustrative Breadth of Responsibilities:

• Lead the integration from Marianas 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.

Requirements/Skills:

• Bachelors or Masters degree in relevant scientific or engineering discipline with 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.

Mariana Oncologys Principles

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