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Mariana Oncology · 2 weeks ago

Associate Director, Quality Systems

Watertown, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$157K/yr - $213K/yr

8+ years exp

Mariana Oncology is advancing personalized medicine and radiopharmaceuticals, and they are seeking an experienced Associate Director, Quality Systems to join their Quality Assurance organization. The role involves leading the integration of quality management systems and collaborating cross-functionally to enhance quality processes and systems.

BioinformaticsBiometricsBiopharmaBiotechnologyOncology

H1B Sponsor Likely

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

Qualification

Quality Management SystemsGMP DocumentationElectronic Document ManagementPharmaceutical Industry ExperienceSystem Integration ExperienceContinuous ImprovementCross-functional Collaboration

Required

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

Must have experience implementing an electronic Document Management System

Strong understanding of industry quality management tools, quality systems

Must be willing to work onsite in Watertown 4 days per week

Preferred

Experience working in an onsite GMP manufacturing facility is highly preferred

Experience navigating large, complex pharmaceutical organization(s) is preferred

System integration experience and/or company integration experience is highly preferred

Benefits

Strong health insurance package

Life insurance

Disability benefits

401(k) with company contribution and match

Tuition reimbursement

Generous flexible time off program

Company

Mariana Oncology

Mariana Oncology is a biotechnology research industry.

Founded in 2021

Watertown, Massachusetts, USA

11-50 employees

https://www.marianaoncology.com

H1B Sponsorship

Mariana Oncology has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (1)