Associate Director, Quality Systems

Reporting:

Vice President, Quality Assurance

Description:

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

Illustrative Breadth of 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.

Requirements/Skills:

Bachelor’s or Master’s 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 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 $157,250.00 and $212,750.00 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.