Senior Director, Quality Systems/QMS
Scorpion Therapeutics
Key Responsibilities Provide strategic leadership/oversight to ensure global QMS health, integrity, and effectiveness across all GxP domains, products, modalities, and geographies. Align Quality Systems with global regulatory expectations; identify/assess/control QMS-level risks; drive quality-by-design and continuous improvement; ensure lessons learned become systemic improvements. Own and evolve the QSO/Quality Systems model and strategic roadmap (e.g., scaling, digital readiness, emerging technologies/novel modalities). Implement and govern the Quality Systems Ownership model; lead Quality Systems Owners accountable for cross-QMS quality systems (e.g., Quality Risk, Vendor Quality, Event, Knowledge, Data Integrity). Chair integrated Quality Systems governance (e.g., PONs; interfaces with operational governance such as QMR) and align internal/external (outsourced/third-party) standards and expectations. Model Quality Leadership; champion quality culture, transparency, and integrity; partner with QA and enterprise functions to translate into operating standards and inspection readiness. Lead, develop, and mentor quality professionals; act as change agent for QMS transformation (including digitization). Required Qualifications BS/MS/JD/MD/PhD in Life Sciences (or equivalent). 15 years relevant experience; 7 years in global supervisory/leadership roles. GMP and/or GCP operational/quality oversight experience (additional breadth preferred). Built sustainable Quality Systems/QMS models and governance to ensure compliance across GxP. In-Depth Knowledge/Skills Strong knowledge of global regulations and ICH guidance; direct authority experience or multi-region health authority interactions. 10+ years QA leadership across audit/compliance/inspection/operational quality. Enterprise and cross-functional influence; strategic change leadership. Experience across preclinical, clinical, and CMC with quality/risk management principles. Process improvement (Lean, DMAIC, Six Sigma), problem-solving, data analysis. Travel up to 15%. #J-18808-Ljbffr Scorpion Therapeutics
$254k - $295k
...implement, and continuously improve an integrated QMS to support all GxP activities. Partner with GMP and GCP Quality leads to build practical, fit-for-purpose... ...driving consistent and effective use of quality systems. Collaborate with IT, Quality leaders, and internal...Senior$213.6k - $320.4k
## Senior Director, Quality Systems/QMSApplylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-29380**Job Description... ..., efficiency, and effectiveness throughout the global QMS.**Key Responsibilities:*** Quality Management System...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per week- Vertex Pharmaceuticals in Boston seeks a Senior Director, Quality Systems to lead quality management and systems across global operations. The ideal candidate will have a strong background in regulatory compliance, operational excellence, and quality oversight. This role...Senior
- Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements... ...and Responsibilities Business Process Management Systems (e.g. Quality Management Systems, Integrated Management Systems). Work to...SeniorRelocation package
$252k - $269k
Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes... ...and manages risk-based quality systems, collaborates across departments to advance... ...qualified resources to support the QMS and ensure delivery of company goals....SeniorLocal areaWorldwide- ...Scholar Rock is seeking an experienced and motivated Director of Quality Systems and GxP Compliance. Reporting to the Senior Director, Global Quality Systems and Compliance,... ...Support global Quality Management System (QMS) transition from clinical-stage operations to a...
$216k - $324k
Job Description The Senior Director, Manufacturing Technical Sciences QA is... ...for end-to-end technical quality oversight of cell and genetic... ...compliance frameworks, guidance, and systems are in place to keep the... ...expectations as well as Vertex’s QMS for products throughout the...SeniorSummer workRemote workFlexible hours2 days per week3 days per week$250k - $290k
Senior GCP Quality Assurance Lead - Permanent - Boston - Remote Take the lead in delivering world... ...Provide QA oversight for pharmacovigilance systems and activities. Support compliance... ...improvement of the Quality Management System (QMS). Contribute to SOP development,...SeniorPermanent employmentRemote work$160k - $180k
Senior Manager, GCP Clinical Quality (Hybrid) Responsibilities Perform internal/external audits to ensure compliance with GCP/GVP regulations and guidelines... ...approach globally. Support Quality Management System (QMS), including QA review/approval of deviations, CAPAs, and...Senior$90.63k - $181.25k
...gain an advantage, sharpen performance, and build lasting success. WE WANT PEOPLE WHO ARE PASSIONATE ABOUT SYSTEMS AND QUALITY We are looking for a hands-on Senior Systems Integration QA / Team Lead to oversee end-to-end quality assurance for our live sports video...SeniorFull time$254k - $295k
Scorpion Therapeutics is seeking a qualified candidate to design and implement an integrated Quality Management System (QMS) to support GxP activities. You will partner with GMP and GCP Quality leads, lead QMS governance, and ensure ongoing compliance with regulatory standards...Senior$160k - $187k
.... Essential Job Functions Reporting to the Executive Director of Quality Assurance, the Senior Manager, Clinical Quality Assurance (CQA) is responsible... ...audits. Working knowledge of Veeva (or similar QMS e-system) required. Knowledge of Inspection Management Tools a...SeniorSummer holidayWork at officeHome officeKura Oncology, Inc.
Boston, MA4 days ago$160k - $180k
...best‑in‑class potential. About the Role As the Senior Manager, GCP Clinical Quality reporting to the Senior Director GCP Quality Assurance, you will partner with... ...approach globally. Support Quality Management System (QMS) activities, including review/approval of deviations...SeniorWork at office2 days per week$124.63k - $179.22k
The Manager/Sr. Manager Training & Quality Systems will report to the Director Quality Systems and be responsible for the GxP Quality Training program at Eyepoint. This position will require the ability to build strong relationships with partner groups who support GLP,...Senior- ...us at About the role The Director/Sr. Dir, GCP Quality Assurance is Prilenia's primary... ...cross‑functional teams and senior leadership. Roles and... ...to Drug Safety: oversee PV systems, vendor quality performance... ...applicable national regulations. QMS & Cross‑Functional...SeniorFull timeRemote workFlexible hours
$148k - $222k
Job Description Position Summary The Quality Systems Associate Director supports strategic design of and ensures tactical execution of quality systems... ...the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation...Full timeSummer workLocal areaRemote workFlexible hours2 days per week- ...access, and additive manufacturing. ABCorp is seeking a Senior Quality Systems Specialist to help strengthen and standardize our quality operating... ...discipline and attention to detail ~ Experience with QMS, ERP, or workflow systems Nice to Have Experience...SeniorWorldwide
ABCorp
West Roxbury, MA3 days ago $260k - $320k
...patients suffering from serious diseases. Position Overview The Senior Director, Product Quality Assurance, Cambridge (PQA) will be responsible for... ...mitigation strategies. Create and ensure appropriate quality systems are in place to support product release in a compliant...SeniorContract workWorldwide- Responsibilities Provide end-to-end GMP Quality oversight of CDMOs, contract laboratories, and packaging/labeling vendors supporting clinical... .... Integrate external manufacturing processes into core QMS elements (deviations, CAPA, change control, and product complaints...SeniorContract work
- Scorpion Therapeutics is seeking a Senior QA Specialist focused on GxP Document Control and Quality Systems in Boston. This hybrid position requires leading document control in the electronic QMS, supporting audits, and maintaining GxP compliance. The ideal candidate will...Senior
$134k - $186k
...Ultrasound QMS Manager In this role you Are responsible for overseeing... ...data to identify trends, systemic issues, and improvement opportunities... ...implementing effective solutions to enhance quality and compliance. • Serves as a senior quality advisor and key point of...Full timeWork at officeLocal areaRemote workWork visaRelocation package3 days per weekPhilips
Cambridge, MA1 day ago$130k - $160k
...at our site in Norfolk, Virginia Site Quality leader and Management Representative responsible... ...performance of products and the quality system. Develops relationships with key... ...including hourly production employees through senior management. Must possess excellent...SeniorHourly payWork experience placementFlexible hoursZimmer Biomet
Boston, MA2 days ago- Bicara Therapeutics is seeking a Senior Director, Quality Management Systems in Boston to build and lead the company’s QMS from the ground up. This leadership role will ensure operational efficiency and compliance with GxP activities. The ideal candidate will have over...
$191.25k - $260k
...matters and every contribution drives progress. Join us! As Senior Director, Quality, you will provide strategic leadership and oversight for... ...implementing, and continuously improving a robust Quality Management System that meets regulatory requirements, supports business...SeniorWorldwideFlexible hoursRepligen
Waltham, MA4 days ago$155k - $278.3k
...Autodesk, we are redefining how products are conceived, engineered, and manufactured. We are seeking a Senior Principal UX Designer who operates at the intersection of UX, systems thinking, and computational design — someone who can shape the future of AI-powered product...SeniorRemote jobFor contractors- ...Description Job Description Summary: The Hypersonic and Advanced Weapons group at Draper is seeking a Senior Guidance, Navigation, and Control (GNC) Systems Engineer to work within and lead multi-disciplinary teams to design next-generation weapon system concepts...Senior
Draper
Cambridge, MA3 days ago - ...Senior Supervisor At Boston Scientific, we'll give you the opportunity to harness all... ...Senior Supervisor will support the Global Quality Distribution Product Controls (DPC) team... ...and budgets; ensure adherence to quality system, regulatory and safety policies and procedures...SeniorWork at officeLocal area3 days per week
Intracept by Boston Scientific
Boston, MA5 days ago $146k - $194k
Slope in Quincy, Massachusetts is seeking a highly motivated Systems Engineer to join the Maritime team. This role involves working closely with program leadership and various cross-departments to integrate systems for the next generation of Autonomous Underwater Vehicles...Senior$166k - $220k
Anduril Industries is seeking a Reliability Engineer in Quincy, Massachusetts to oversee the reliability of advanced defense technology systems. In this role, you will perform predictive analysis and lead failure investigations, ensuring robust designs from concept to...Senior$82.3k - $220k
...Stark Draper Laboratory, Inc. is seeking a Senior Requirements & Concepts Engineer to join... ..., MA. This role involves developing system concepts and requirements for critical defense... ...partners, ensuring the delivery of high-quality systems. Comprehensive benefits and a competitive...Senior
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