Vice President, Quality

remixtherapeutics

Watertown6d ago

Seniority: Lead

About the role

Remix Therapeutics is a clinical-stage biopharmaceutical company pioneering a new class of medicines that modulate RNA splicing to address the underlying biology of disease. Our lead program, REM-422, targets pre-mRNA splicing in oncology and represents a fundamentally differentiated approach to drug discovery. Headquartered in Watertown, MA, Remix is advancing its pipeline with the urgency and scientific rigor that patients deserve.  Position Summary: Remix is seeking an exceptional Vice President of Quality to serve as the architect and guardian of our quality organization at a pivotal moment in our growth. Reporting to the Chief Operating Officer, this leader will define the global quality vision and build the systems, culture, and capabilities required to advance REM-422 from clinical development through potential commercialization.  This is a rare opportunity to build a world-class quality function from the ground up within a science-driven organization where quality is understood as a patient safety imperative — not a compliance afterthought. The VP of Quality will bring deep expertise across GxP disciplines, a risk-based mindset, and the leadership presence to inspire confidence across internal teams, external partners, and Health Authorities alike.  Key Responsibilities: Quality Vision & Strategy  <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Define and drive the Quality vision, objectives, and culture of Remix, establishing quality as a strategic enabler of the company's mission </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Design, develop, and oversee a risk-based, phase-appropriate Quality Management System (QMS) spanning pre-clinical through commercialization </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Ensure the QMS meets FDA, EMA, and ICH standards while remaining agile and fit-for-purpose for a clinical-stage organization </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Build and lead Remix's quality organization from the ground up; hire and develop a small, high-impact team while establishing the infrastructure, processes, and culture to scale alongside the pipeline </li> </ul> GxP Compliance & Health Authority Engagement  <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Lead Health Authority inspections (FDA, EMA, and other applicable agencies) and all inspection readiness activities across GxP disciplines </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">Serve as primary quality point of contact in regulatory interactions and submissions; ensure quality sections of INDs, NDAs/BLAs, MAAs, and other submissions meet agency expectations </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">Maintain a comprehensive inspection readiness program ensuring the organization is always in a state of audit readiness </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Monitor evolving regulatory requirements, ICH guidance, and industry best practices; assess impact and implement appropriate updates to the QMS </li> </ul> GCP & Clinical Quality  <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1">Provide GCP quality oversight across all clinical development programs, including protocol development, site qualification, monitoring, and data integrity </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1">Partner with Drug Safety/Pharmacovigilance to provide quality oversight of PV activities, including SAE reconciliation, SUSAR reporting, PBRER/DSUR quality review, and inspection readiness for safety databases and processes </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1">Ensure pharmacovigilance quality agreements and audit programs are in place with CROs and technology vendors supporting safety data collection and reporting </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Collaborate closely with Clinical Operations, Biostatistics, and Regulatory Affairs to ensure clinical data quality standards are embedded throughout trial execution </li> </ul> GMP & CMC Quality  <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1">Oversee quality aspects of small molecule drug substance and drug product manufacturing, including batch review and product release at Contract Manufacturing Organizations (CMOs) </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1">Establish and maintain robust supplier qualification, oversight, and performance management programs for CMOs and Contract Research Organizations (CROs) </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="15" data-aria-level="1">Lead GMP vendor qualification audits and for-cause audits; maintain a risk-stratified audit schedule </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="16" data-aria-level="1">Partner with CMC, Regulatory, and Supply Chain to ensure product quality across the supply chain from development through commercial launch </li> </ul> Quality Systems & Training  <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="17" data-aria-level="1">Own and continuously improve core QMS elements: document management, change control, deviation and CAPA management, risk management, and quality metrics </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="18" data-aria-level="1">Design and implement a robust GxP training program; ensure training compliance is maintained across all relevant functions and third-party partners </li> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1">Leverage quality metrics and KPIs to provide executive leadership with meaningful data-driven insights on quality performance and risk </li> </ul> Qualifications: <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="20" data-aria-level="1">Masters degree or higher in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="21" data-aria-level="1">15+ years of progressive pharmaceutical/biotech industry experience, with 10+ years in quality management and leadership roles of increasing scope </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="22" data-aria-level="1">Proven track record building, leading, and scaling quality organizations at clinical-stage and/or commercial-stage companies </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="23" data-aria-level="1">Deep expertise in GCP and GMP compliance </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="24" data-aria-level="1">Demonstrated success leading or hosting FDA and/or EMA GxP inspections; direct experience managing inspection responses and regulatory action items </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="25" data-aria-level="1">Expert knowledge of FDA, EMA, and ICH guidelines and regulations applicable across the drug development lifecycle </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="26" data-aria-level="1">Experience providing quality oversight of small molecule CMOs and clinical CROs in a virtual or hybrid operating model </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="27" data-aria-level="1">Exceptional leadership presence, integrity, and judgment; thrives in a dynamic, fast-paced environment where agility and accountability coexist </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="28" data-aria-level="1">Familiarity with oncology drug development and oncology-specific clinical quality considerations </li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":260,"335559991":260,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="29" data-aria-level="1">Working knowledge of EU GMP requirements and experience with dual US/EU regulatory programs </li> </ul> Salary Range $293,000 - $358,000 USD This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable.  Actual salaries may vary based on factors, such as skill, experience, and qualification for the role.

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