Vice President of Quality

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established three platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts with an additional site based in Watertown, Massachusetts.

Job Summary:

Strand is looking for a highly motivated and innovative candidate for the role of Vice President of Quality. The expectation is that the Vice President of Quality will be leading and strategically directing QA compliance of all GXP activities. This individual will develop, maintain, and continually improve Quality Operations, the Quality Management System, the Quality Assurance program, and the Training Program, as well as provide overall Quality and Compliance oversight for the manufacturing and supply chain process to support Strand's clinical campaigns. Reporting to the President, Co-Founder & Head of R&D, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for Strand along with extensive experience building and managing all aspects of the Quality Department.

Primary Responsibilities:

• Leading and strategically directing QA compliance of all GMP activities.
• Building the Strand Quality Organization.
• Develop, maintain, and continually improve Quality Operations, the Quality Management System, the Quality Assurance program, and the Training Program.
• Provide overall Quality and Compliance oversight for the manufacturing and supply chain process to support Strand's clinical campaigns.
• Responsible for supplier qualification and audit program.
• Provide Quality guidance and be accountable for the continuous development, execution and administration of a GxP Quality System meeting all compliance requirements with respect to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).
• Identify, implement, and develop the GxP Quality Management System, including the appropriate processes, procedures, and subsystems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
• Establish and maintain appropriate development phase GMP compliance for product manufacture, testing, and stability.
• Establish and maintain appropriate quality oversight for GxP activities.
• Review and assess production and testing methods, specifications, validations, reference materials and test results.
• Manage audit programs against GxP standards, FDA/ICH requirements, and other regulatory standards.
• Ensure timely resolution of any identified issues.
• Own the planning, review, and execution of all batch documentation from internal and/or external activities and complete material/product disposition activities.

Qualifications:

• B.S. or Advanced Degree with 10+ years of industrial experience in a GMP quality function at a biotechnology or pharmaceutical organization.
• In-depth understanding of quality principles and GMP/ICH/FDA regulations presented by the FDA/global health authorities.
• Extensive experience with the management and oversight of all batch documentation and other records essential for GMP production.
• Experience with quality operations in a manufacturing capacity for mRNA and/or nucleic acid-based products highly preferred.
• Technical knowledge of analytical method qualification, process validation and establishing product specifications preferred.
• Proficient with Quality by Design (QbD) principles and philosophy.
• Track record of completing deliverables within specified timelines.
• Independently motivated, detail oriented and good problem-solving ability.
• Excellent organizational skills.
• Able to multi-task in an extremely fast-paced environment with changing priorities.

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand's goals.

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: Commensurate with role and experience