Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2022.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
How do you know if you’re the right fit?
Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding are what we call ‘another day at Turnstone’? At Turnstone, the science drives decision making, and our therapies are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.
If you are interested in being a part of a growing Regulatory Affairs and Quality Assurance team, then this role may be for you! As the Manager, Quality Assurance, reporting to the Head of Quality you will support the team to establish and implement the quality systems which enable GXP compliance in accordance with country regulations and guidelines, as well as the company’s policies and procedures. The focus will be on GMP activities, with strong interfaces to the technical operations team, the clinical operations team (GCP) and the pre-clinical/R&D team (GLP).
The responsibilities and critical expectations include the following:
- Develop, establish and maintain QA programs, policies, and procedures to ensure GxP compliance of clinical trial material
- Serve as QA Subject Matter Expert (SME) in computer system validation, data integrity ,electronic records and signatures for GxP activities including GCP, GVP and GMP. Provide Computer System QA Support to CSV project teams
- Perform QA review of CSV deliverables including validation plans, user requirements, executed test scripts and report
- Evaluate change controls for computerized systems to ensure adequate testing is performed
- Manage and maintain the periodic review system to assure computerized systems are maintained in a validated state and in compliance with applicable regulations and SOPs
- Serve as the CSV SME during audits and inspections by business partners and regulatory agencies
- Train business and technical users involved in Validation activities Data Integrity requirements
- Review and approve IQ, OQ and PQ protocols and reports
- Review and approve Validation Plans and Validation Reports
- Perform or oversee the conduct of CSV audits of internal computerized systems, computer software suppliers, hosted data centers and systems used by GxP providers.
- Manage the CSV audit program including the annual audit schedule, development of audit plans and reports, and tracking of CSV related CAPAs
- Perform record review and disposition activities for clinical trial material including manufacturing, testing and labelling/packaging batch records
- Lead investigations with vendors and interdepartmental teams to resolve potential product quality issues.
- Oversee the generation, review and/or disposition of internal and external documents used in GxP activities.
- Act as the single point of QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues
- Drive the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GxPs
- Interpret regulatory agency policies and guidance as it pertains to QA issues.
- Review CMC documents submitted to regulatory agencies
- Develop work instructions and/or standard operating procedures
What’s in it for you?
In this role, you will have the opportunity to develop your ability to build processes and drive these to implementation. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!
Experience & Qualifications:
- University graduate in a technical area (e.g., Engineering, Computer Science, Chemistry)
- Experience in the pharmaceutical/biotech industry in technical with quality assurance roles (5 years+), ideally across a full range of multiple clinical development phases
- QA Experience in computer system validation in the pharmaceutical industry is required
- Sound knowledge of GMP requirements, CFR 21- Part 11, Eudralex Vol. 4 Annex 11, FDA Data Integrity Guidance, MHRA Data Integrity Guidance, GAMP5
- Experienced with computer system validation in a variety of GXP areas including clinical development, pharmacovigilance, supply chain and quality
- Understanding of biologics and cell therapy manufacturing processes in GXP environments will be viewed as a positive
- Experience with regulatory authority or client/partner inspections/audits, and conduct of supplier/manufacturer audits
- Experience with Microsoft Computer Products (Word, Excel, Access, PowerPoint).
- Demonstrated ability to manage multiple projects and variable workloads with demanding timelines
- Strong interpersonal, teamwork, and organizational skills; effective oral and written communication skills
- The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility