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.
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Job Summary:Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company.Reporting to the President, Co-founder and Head of R&D, the Vice President of Quality will be a key member of the Management team, shaping the structure of the organization and providing a strong leadership role that ensures implementation of and compliance with global quality standards, in addition to providing strategic and operational quality guidance to Strand Therapeutics employees, delivering quality strategies and operational frameworks supporting early product development through to and beyond product registration.This individual will ensure that the company implements and maintains a Quality system which follows global GxP global compliance standards. It is also expected the candidate will work closely with all functional areas at Strand Therapeutics and develop a strong corporate Quality culture.Primary Responsibilities:The Vice President of Quality will develop long-term Quality strategies, providing leadership in policy setting, operational support, driving a work culture, grounded in transparency, credibility and trust and fully committed to patient safety, compliance, providing quality leadership and excellence in a changing environment.
This includes continued development and implementation of the GxP compliant quality system architecture, staffing, and associated processes thereby ensuring adequate checks and balances exist to assure compliance with global regulations. Additional responsibilities will include but not be limited to:
- Build the Quality organization, including development and maintenance of phase appropriate quality management systems (QMS), ensuring compliance with GxP and global regulations supporting supply chain management and external GMP manufacturing partners, clinical trials execution and reporting, and management of GxP external vendors (eg CDMOs, CRO’s, contract test laboratories, investigator sites and other vendor services)
- Establish and maintain an adequate organizational structure, provide adequate resources and actively participate in management reviews to ensure the quality system is suitable and effective to satisfy regulatory requirements and the company's Quality policy and objectives across GxP functional areas
- Develop and implement continued improvements in Quality Systems to reduce complexity; improve effectiveness, efficiencies and productivity, supporting sustainability and harmonization
- Assure established QMS robustly supports release and disposition of all Strand Therapeutics products for use in and compliant execution of clinical research. This includes procedures for document control, deviation management, corrective and preventive actions (CAPAs), and continuous improvement, ensuring all identified actions / observations are appropriate to remediate identified deficiencies and are completed in a timely manner and establish processes to ensure effectivity
- Assure established processes and procedures safeguard the rights, safety, and well-being of clinical trial participants, as well as ensuring the integrity and reliability of clinical trial data
- Responsible for the continuous improvement of quality systems, processes, and procedures to enhance the overall quality and compliance of clinical trial conduct. This includes conducting root cause analyses of compliance issues and implementing corrective and preventive actions to prevent recurrence
- Ensure a robust and risk-based Audit program is successfully realized throughout the vendor network, assuring regulatory compliant Quality Management practices and procedures at external manufacturing, testing and clinical sites through the audit function are met
- Effectively communicate progress and issue resolution to appropriate internal/external stakeholders and through Quality Management Review
- Continued development of GxP training systems for company employees
- Providing ongoing education and training to support the effectiveness of Strand Therapeutics compliance programs
- Development of QA departmental budgets supporting the corporate and departmental goals and objectives and responsible for controlling the budget during the fiscal year
Qualifications:
- 10+ years in a Quality Leadership role in the life sciences industry
- The candidate must be a highly articulate, authentic and fluid communicator in both individual and group settings. This position requires heightened intelligence, mature business judgement and a passion for developing novel therapeutics
- Prior experience in creating, building, implementing, and managing a Quality function
- Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the management of compliance
- Strategic leadership and thinking to ensure compliance is delivered cost effectively
- The candidate should be capable of operating with a high level of autonomy, but get into operational details as required
- Strong management and organizational skills; ability to prioritize and manage through complex processes/projects
- Ability to read, analyze, and interpret business periodicals, common scientific, professional and technical journals, governmental regulations and legal documents
- Ability to deal with abstract and concrete variables in situations where only limited standardization exists.
- Extensive knowledge of FDA/EMA regulatory requirements applicable to phase appropriate biologics manufacturing
- Ability to apply GxP regulations and other FDA and international guidelines to all aspects of the position
- Excellent troubleshooting skills and ability to solve complex issues
- Strong interpersonal and communication skills, verbal and written
- Proven Leadership skills
- Ability to function in a rapidly changing environment & handle multiple 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-timeSalary: Commensurate with role and experience
