Assoc. Director OR Director, Quality Assurance

Reporting:

Vice President Quality Assurance

Description:

Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors. We are based in Arsenal Yards in Watertown, MA. We have our office space, research labs, and GMP manufacturing suite all in one place, with a beautiful surrounding area within Arsenal Yards.

We are seeking an experienced Associate Director/Director Quality Assurance to join Mariana's Quality Assurance organization, advancing personalized medicine and radiopharmaceuticals. This role involves developing quality assurance programs and ensuring regulatory compliance in a global cGMP drug substance and drug product manufacturing environment.

Illustrative Breadth of Responsibilities:

• Provide onsite operational QA support for cGMP clinical stage aseptic drug product manufacturing for radioligand therapies. This includes drafting of master batch records, review of executed batch records, release of raw materials and finished product, writing and reviewing deviations, CAPAs, and change requests related to manufacturing process, manufacturing equipment, analytical instruments, facilities and GxP computer systems.

• Support cGMP manufacturing and quality control metrology program, including development and review of IQ/OQ/PQ documentation for instruments, equipment, and facilities. Schedule vendors to perform qualifications and preventive maintenance.

• Support GxP training program (GMP, GCP, GLP and Computer System Validation) by creating training curricula, assigning required training, developing and presenting training modules, and maintaining training records.

• Develop quality management system SOPs. Review quality assurance, manufacturing, and quality control procedures.

• Conduct internal GxP process audits and source data verification audits.

• Perform qualification activities to support the GxP vendor management program including vendor audits, evaluating vendor qualification questionnaires, and writing vendor risk assessments.

• Review technology transfer, process validation, manufacturing process risk analysis, product stability, and other types of technical reports to support IND and global regulatory submissions.

• Collect and report quality assurance and cGxP metrics at Quality Management Review meetings.

• Maintain electronic and paper-based quality document archive.

Requirements/Skills:

• Position is a hybrid role with 4 days a week attendance required in the Watertown manufacturing facility to perform onsite QA activities related to cGMP manufacturing and quality control testing.
• Bachelor's degree in engineering or science with at least five years of experience working in a cGMP aseptic manufacturing and quality control testing environment in the pharmaceutical or biotechnology industry.
• Experience with working in and implementing a global QMS adhering to EU GMP Vol 4 Part I, IV, and applicable EU GMP Annexes (including but not limited to Annex 1 and Annex 3), 21 CFR 210-212, 21CFR Part 11, ICH, and USP requirements.
• Experience working in QA roles related to GCP, GLP, Computer Systems Validation (CSV) compliance, or with radiopharmaceuticals will be considered as a plus.
• Ability to work collaboratively with cross functional teams including manufacturing, quality control, supply chain, technical development, and facilities personnel.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.

Mariana Oncology's Principles

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

What Success Looks Like at Mariana Oncology

Entrepreneurial Mindset:

We are all working in an exciting and new space of life sciences, and the only way we're going to be successful is by working together. We will be tested in ways that require us to improve our skills, learn from our mistakes, and take continuous action on ideas. By sharing our work, explaining our processes, and highlighting the takeaways we derive from our experiments, we will all learn and grow as a team.

Believing the Glass is Half-Full and Having Self-Confidence:

We need you to bring all your courage and willingness to advocate positions based on doing the right things; identify and focus on the positives and potential of every business and scientific opportunity. There will be times when we're in uncharted territory and working without a lot of direction. When things get challenging, we must look out for each other. Sometimes, even something as simple as saying, "thank you" or "great work" can go a long way.

Leadership:

We're looking for role models who can think and work across the enterprise and inspire others to perform at their very best. If you are passionate about improving the lives of people suffering from cancer, empowering others, and being a positive force for change, the join us. Together we can defeat cancer's toughest tumors!

Location: Watertown, MA, US

Posted Date: 11/25/2024