Clinical QA Manager - Regulatory & Audit Leader
Mass General Brigham
Mass General Brigham is seeking a Quality Assurance Manager for the Neurological Clinical Research Institute (NCRI) at 399 Revolution Drive, Boston. This role directs QA activities across clinical studies, ensuring adherence to GCP, regulations, and the NCRI Quality Management Plan. Under supervision of Senior QA leadership, the QAM implements QA initiatives, conducts audits, drafts SOPs, and supports inspections. #J-18808-Ljbffr Mass General Brigham
$109.3k - $124.9k
The Regulatory Compliance Manager at Dana-Farber is responsible for coordinating and leading regulatory... ...Manager works under the Director of Clinical Regulatory Compliance to lead initiatives... ..., Dana-Farber Cancer Institute is a leader in life changing breakthroughs in...Suggested- ...Pharmaceutical Co. in Cambridge, MA seeks a Senior Manager, GRA Audits, Inspections and Compliance to lead global regulatory audits and inspections coordination across... .... The role partners with International Clinical Trial Regulatory Leads and Global Regulatory Leads...Suggested
- Takeda Pharmaceutical Company Limited in Cambridge, MA is seeking a Senior Manager for GRA Audits, Inspections and Compliance (GRAIC) to lead global audits and drive regulatory readiness across programs. The role partners with regional leads, aligns regulatory initiatives...Suggested
- ...Description Position Overview The Quality & Regulatory Affairs Manager is responsible for ensuring... ...and coordinating internal and external audits. Key Responsibilities Develop, implement... ...relationship-building abilities. Effective team leader and collaborator. Ability to work...SuggestedWork at office
$63.25k - $102.6k
...directly to the Sr Project Manager and/or Project Director of a large global clinical study. This position... ...agencies and other regulatory bodies. Collecting, reviewing... ..., Quality Assurance (QA) and Regulatory Affairs... ...external sponsor audits and inspections performed...SuggestedWork experience placementWork at officeRemote workShift work- Proclinical seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to lead quality oversight of global PV systems from... ...Director of Global PV Quality Assurance and focuses on GVP compliance, audit programs, inspection readiness, and cross-functional...Remote job
- ...to strategically lead compliance across Global Medical. Partner with senior leaders to strengthen risk management, governance, and policy training, aligning with Takeda values and regulatory requirements. The role focuses on embedding ethical decision-making, driving...
- Mass General Brigham's NCRI unit seeks a Director of Quality Assurance and Regulatory Affairs to lead the organization’s QA programs across clinical trials, audits, and regulatory compliance. You will develop and implement QA strategies, supervise a team of 10+ staff,...
- Mass General Brigham NCRI seeks a Director of Quality Assurance and Regulatory Affairs to lead QA strategies, audits, and regulatory programs across clinical trials, ensuring FDA and ICH/GCP compliance. You will oversee 10+ QA staff, coordinate with regulators and study...
$116k - $145k
...our website: The Importance of the Role Participates in clinical and nonclinical regulatory strategic discussions, supports multiple products’... ...updates cross- functionally as neededEnsures documentation management and record keeping are compliant with regulatory expectations...Full timeWork at officeRemote work- ...Weds Foods, Watertown plant near Boston, is seeking a Production Supervisor with QC focus to oversee quality control programs and audits. The role emphasizes data collection, documentation, and cross‑functional collaboration to ensure product quality and compliance. The...
- Takeda in Cambridge, MA seeks a Senior Manager, GRA Audits, Inspections and Compliance to lead global GCP audits and inspections, ensuring readiness and regulatory compliance. The role partners with Regulatory Leads and cross-functional teams to align initiatives and improve...
- ...Food Safety & Quality Assurance Manager plays a key leadership role in... ...of food safety, quality, and regulatory compliance across all... ...departments, and maintaining audit readiness. The ideal candidate... ...reports to FSQA leadership. Oversee QA laboratory programs and equipment...Local area
- ...director-level subject matter expert to build clinical operations compliance while upholding... ...procedures and support of issue management for the clinical programs, and ensuring... ...with cross-functional team members within Regulatory, Quality, Data Sciences, Clinical...Work at officeFlexible hours
$87.2k - $117.2k
...member in supporting and executing operational and/or compliance audits, advisory projects and SOX/C-SOX assessment, including planning... ...Business Partnership and Risk AssessmentSupport Internal Audit Managers in fostering and maintaining business partnerships with...Hourly payWork at officeLocal areaAfternoon shift$200.68k - $215.27k
...JOB LOCATION Cambridge, MA POSITION Senior Manager, Global Regulatory Affairs, Marketed Products POSITION DESCRIPTION assist the... ...tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross functionally to...Minimum wageFull timeWork at officeLocal areaRemote workWorldwide- Job title: Senior Manager Regulatory Affairs Advertising and Promotion Location: Morristown, NJ/Cambridge, MA About The Job As the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting...Work experience placement
$135.4k - $183.2k
Overview The Senior Manager, Regulatory Sciences Compliance (QSC... ...product lifecycle from Good Clinical Practice (GCP) through... ...quality, and GMP audit execution, are outside... ...accountable owners QA partners. Ensure appropriate... ...Alnylam We are the leader in RNAi therapeutics-...Full timeTemporary workLocal areaFlexible hours- ...on LinkedIn, Facebook, Instagram, X and YouTube. The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada is responsible for... ...communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial....Work at officeRemote work
- Sanofi US Services in Morristown, NJ / Cambridge, MA is seeking a Senior Manager, Regulatory Affairs Advertising and Promotion to lead independent review of advertising and promotional materials and help develop regulatory strategies for campaigns. You will serve as regulatory...
$81.97k - $122.96k
...the way. Find a home for your career here. Join us and embrace a culture of Caring. Connecting. Growing together. The RN Clinical Manager Hospice provides leadership, supervision, and coordination of therapy services to ensure high-quality, compliant, and cost-effective...Minimum wageFull timeWork experience placementLocal areaImmediate startRelocation package$149k - $166k
...disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for... ...more information, please visit .Position SummaryThe Senior Manager, Regulatory Operations will plan, coordinate, and drive...Full timeTemporary work$160k - $180k
Senior Manager, Quality Assurance Vendor & Audit Management About Genetix Biotherapeutics At Genetix Biotherapeutics... ...Description The Senior Manager, QA Compliance - Vendor & Audit... ...ensure compliance with applicable regulatory requirements, industry standards, and...Full timeContract workWork at officeRemote workFlexible hours3 days per week$109k - $145.75k
About This RoleAs the Manager, IT Audit at Biogen, you will play a pivotal role in strengthening our technology risk management, cybersecurity... ...transcends traditional IT audit execution by partnering with leaders across IT, Cyber, and the business to deliver risk-based,...Full timeTemporary workLocal area$196.7k - $353.4k
...is seeking a Sr. Director of Regulatory Strategy to support oncology... ...Director will be a strategic leader within Regulatory Affairs, responsible... ...strategy through the clinical and nonclinical development processes... ...data, organizes and manages participation in meetings. Negotiates...Permanent employmentWork at officeWork from home$196.7k - $353.4k
...is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy... ...Director will be a strategic leader within Global Regulatory... ...strategy through the clinical and nonclinical development processes... ...data, organizes and manages participation in meetings. Negotiates...Permanent employmentWork at officeWork from home$265k - $331k
...strategic Senior Director of Regulatory Strategy to lead regulatory... ...with Medical Affairs, Clinical Development, CMC, Quality, Commercial... ...for post-approval lifecycle management activities, label expansions... ...ability to influence senior leaders and drive decisions across...Work at officeFlexible hours3 days per week$227.9k - $308.3k
...direction for the GVP QA function and... ...excellence, and long-term regulatory compliance.This... ...compliance risk management, quality metrics,... ...the risk-based GVP audit strategy and PV... ...Quality, Regulatory, Clinical, Commercial, and... ...AlnylamWe are the leader in RNAi therapeutics...Full timeTemporary workLocal areaRemote workFlexible hours$22.3 - $28.49 per hour
Job Description Overview\n If you are a highly motivated individual with tax preparation experience and excellent communication skills, we need you to help our customers complete their taxes using Intuit TurboTax products. You will be working toward advancing our goal...- ...with authorities to ensure compliance with FAA regulations (Part 107, waivers), military range requirements, and internal safety management protocols. Establish telemetry and data pipelines for post-flight analysis, and lead root-cause investigations when anomalies or...Remote workEarly shift
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