Head of Quality Systems and Compliance (AI/SaMD)
Verily Health
Verily Health is seeking a Quality Systems and Compliance Lead to own QA across consumer health, research tools, and medical devices, guiding quality systems and ensuring compliance with global standards. You will architect robust QA processes and drive strategic QA initiatives with measurable impact, coordinating with engineering, product, and operations teams. Key focus areas include ISO 13485:2016 certification, FDA QMSR alignment, CAPA and risk management, and governance for AI/ML-enabled #J-18808-Ljbffr
$228k - $342k
Job DescriptionSenior Director, Quality Data, Digital Systems & ComplianceGxP Data Governance • Data Integrity... ..., Quality Data, Digital Systems & Compliance, serves as a pivotal leader within... ...employees to stay informed on advances in AI, technology, automation, and industry...SuggestedFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$148k - $198k
...lead the integration of lab data and automation, ensuring high-quality scientific operations. This role demands a candidate with over... ...successful applicant will drive team performance and ensure compliance with quality assurance standards while fostering a culture of...Suggested- ...Verastem Oncology seeks an accomplished Senior Vice President of Regulatory Affairs and Quality to lead global regulatory strategy and product quality for the company's small molecule portfolio. This executive will set enterprise-wide priorities, align regulatory, quality...Suggested
- Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic PDQ team, ensuring quality across the biologics portfolio. This hybrid role can be based at the Research Triangle Park, NC or Cambridge, MA, and involves strategic, tactical, and operational...Suggested
$116k - $182.27k
...best of my knowledge.Job DescriptionOBJECTIVES:Computerized Systems Quality Assurance (CS QA) Lead helps deliver on Takedas commitments... ...quality and data integrity by ensuring the quality and regulatory compliance of computerized systems and regulated data. This is...SuggestedMinimum wageWork at officeLocal areaImmediate startRemote workNight shift- ...Ketryx, headquartered in Boston, MA, is seeking a Director of Quality to own the QMS and ISMS, guide AI governance, and drive certification readiness for multiple standards in a regulated software environment. You will lead a QA/RA consulting team, coordinate release...
$175k - $265k
...countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary... ...hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards...Contract work$10k
About This Role: As the Head of Quality for Device and Combination Products, you will lead the... ...regulatory regulations within Biogen's quality system, integrating engineering design and... ...management. Your leadership will drive compliance with regulatory and quality standards...Temporary workLocal area- ...Dyne Therapeutics in Waltham, MA seeks Senior Director, Quality Control to lead QC strategy and operations across clinical and commercial manufacturing, ensuring GMP compliance and inspection readiness. This role collaborates with contract labs and internal units to support...Contract work
- ...Pharmaceuticals seeks a Director of Data Governance, Quality & Enablement to lead enterprise data... ...IT, Data Engineering, Data Products, and Compliance to embed governance into data pipelines... ..., affecting analytics, automation, and AI use cases across the organization. #J-188...
- ...Form Energy is hiring a Manager of Supplier Quality Engineering to build and lead a world-class SQE team at our facilities. You will... ...corrective action programs while shaping Form's quality management system. You'll work with NPI and supply chain teams to ensure PPAP...
- Fagron US is seeking a Quality Site Head for its 503B Outsourcing facility in Canton, MA, overseeing QA/QC, environmental monitoring, and change controls to ensure FDA and state regulatory compliance. The role leads QA/QC investigations, audits, and management reviews,...
- About the job Quality Site Head for the 503B Outsourcing facility in Canton, MA of approximately... ...and continuous improvement of Quality Systems so that they are compliant for Federal... ...inspections and other Regulatory and compliance activities. Key Responsibilities...Contract workFlexible hours
$185.5k - $344.5k
...MAInternal: DirectorLI#-HybridThis role oversees the Study Quality and Compliance team within the Toxicology line function of PCS. This team is... ...part of this role will be to identify and implement a software system that enables effective tracking and analytics of study-...Full time$189k - $238k
...ground, soldier, and maritime systems in 50+ locations world-wide. Much... ..., artificial intelligence (AI), machine learning (ML), and augmented... ...Director of Enterprise Quality will lead the quality... ...strategic leadership role ensures compliance with product quality, certification...Contract workFor contractorsWork experience placementFor subcontractor$184.6k - $277k
Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness... ...the inspection readiness and management system, ensures appropriate escalations, and... ...to stay informed on advances in AI, technology, automation, and industry trends...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week$178k - $221k
...is looking for an Associate Director of Systems Test Engineering to join our Systems Engineering... .../field Method developmentRequirements quality assuranceThis role is responsible for... ...Pi, Arduino.Behavior & controls software: AI / ML / VLAs, perception, planning, controls...Full timeFor contractorsVisa sponsorship$137k - $215.27k
...DescriptionOBJECTIVES:Provides quality assurance oversight of the... ...advice. With the guidance of Head of Clinical Program Quality,... ...communication of significant quality and compliance risks to key stakeholders and... ..., vendors or internal systems in compliance with GCP and...Minimum wageWork at officeLocal areaImmediate startNight shift$228k - $342k
...Senior Director role leading enterprise-wide GxP data governance, data integrity, master data management, computerized systems compliance, and quality analytics. This strategic position partners across Quality, IT, Regulatory, and business functions to establish robust...Work experience placement- ...Senior Director of GMP Quality will establish and maintain quality systems, provide oversight of manufacturing partners and testing laboratories, and ensure regulatory compliance. This hands-on leadership role partners with cross-functional teams from development through...Contract work
- ...Job Description The Associate Director, Quality Systems leads the strategy, design and... ...and operational functions. ~ Ensure compliance with applicable regulations and guidance... ...We may use artificial intelligence (AI) tools to support parts of the hiring process...Work at officeMonday to Friday3 days per week
- ...Job Summary The Food Safety & Quality Assurance Director ensures that multiple... ...audits, crisis management, and regulatory compliance across all jurisdictions. The director partners... ...•Tracks audit performance, identifies systemic risks, and drives corrective action. •...Local areaRemote workFlexible hoursShift work
- ...lead in shaping global pharmacovigilance quality excellence, overseeing critical audit... ...programmes, vendor quality, and regulatory compliance activities. R&D Partners is seeking a... ...quality oversight of global post-marketing PV systems. This role focuses on auditing, QA...
- Director, Quality Control (QC) Location: Cambridge, MA (Hybrid) Overview An innovative... ...excellence, and drive phase-appropriate GMP compliance across a growing modality portfolio.... ...management groups. Establish scalable QC systems and processes that evolve with...
$85k - $130k
Team: Quality & Security & ComplianceCity: BostonState: MA Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies... ...Program Manager role ensures the integrity, compliance, and management of Veeva’s processes within the...Work at officeLocal areaRemote workWork from home3 days per week$184.6k - $277k
...Manufacturing Process & Technical Quality provides Quality leadership... ...the Vertex Quality Management System, global regulatory... ...delivery of commitments.• Ensure compliance with the Vertex Quality Management... ...stay informed on advances in AI, technology, automation, and industry...Full timeSummer workRemote workFlexible hours2 days per week- ...The GMP Operational Quality Senior Manager is an advanced technical resource in the principles... ...application of quality assurance and compliance. This role coordinates or executes... ...enhancements to cross-functional quality systems Conducts GMP document review, including...Contract workShift work
$250k - $302k
...Sr. Director, Quality OperationsSomerville, MassachusettsAt Genetix Biotherapeutics every... ...GxP service providers operate in full compliance with global regulatory requirements and... ...risks across the external network.Quality Systems & GovernanceDrive continuous improvement...Ongoing contractFull timeContract workWork at office3 days per week- ...people, tech experts, researchers, and systems analysts to advance our mission. As a not... ...reporting to the Administrative Director of Quality and partnering closely with the Chief... ...—including Hospital Quality, Compliance, Infection Control, Risk & Safety, and other...Work at officeRemote workFlexible hoursShift work
- ...Korsana Biosciences seeks a Senior Director to lead Biologics Analytical Development and Quality Control for a pipeline spanning preclinical to clinical programs. You will direct analytical method development, qualification, validation, and testing through outsourced partners...
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