Senior Manager, Global GCP Audits & Compliance
Takeda Pharmaceutical Co.
Takeda Pharmaceutical Co. in Cambridge, MA seeks a Senior Manager, GRA Audits, Inspections and Compliance to lead global regulatory audits and inspections coordination across Therapeutic areas, ensuring readiness and compliant practices. The role partners with International Clinical Trial Regulatory Leads and Global Regulatory Leads to support audit readiness, provide live support, and manage post-audit follow-up while driving continuous improvement in regulatory processes and systems. #J-18808-Ljbffr Takeda Pharmaceutical Co.
- Take the lead in shaping global pharmacovigilance quality excellence, overseeing critical audit programmes, vendor quality, and regulatory compliance activities. R&D Partners is seeking a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to provide quality...Senior
- 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...Senior
$137.8k - $206.8k
...DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead... ...ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols,... ...trials, including risk-based audit strategy, quality risk identification...SeniorFull timeSummer workRemote workFlexible hours2 days per week- 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...Senior
$140k - $150k
## Senior Project ManagerApply: Remote: Boston... ...to you.Join our global team dedicated to... ...ROLEThe Sr. Project Manager is an important... ...work/budget, ICH GCP guidelines, and FDA... ...accrual, retention, and compliance.* Assists in TMF... ...in third-party audits and FDA inspections...SeniorPermanent employmentFull timeContract workRemote work- Scientific Search seeks a Senior Clinical Trial Manager to lead start-up and execution of large, global oncology trials from its Boston area base. You will manage CROs... ...timelines and budgets, and ensure regulatory compliance in a fully outsourced model. The role requires...Senior
$200.68k - $215.27k
...following job opportunity:JOB LOCATION: Cambridge, MAPOSITION: Senior Manager, Global Regulatory Affairs, Marketed ProductsPOSITION DESCRIPTION:... ...submissions are provided to local company affiliates in compliance with local regulations and to maintain compliance for products...SeniorMinimum wageFull timeWork at officeLocal areaRemote work- Insurify is seeking a Senior HR Business Partner to support the Support... ...and Sofia, Bulgaria, delivering globally accountable HR programs and coaching managers in a fast-paced environment. You... ...legal and regional teams to ensure compliance and local adaptation. #J-18808-...SeniorLocal area
$124k - $335k
...International Tax Services - Senior Manager, you will provide strategic... ...clients on structuring their global tax positions. Your work... ...advising clients on tax planning, compliance, and strategy, helping... ...including adherence to PwC tax and audit guidance and independence...SeniorFull timeH1bShift work- Senior Manager - Contract - Cambridge, MA (REMOTE) Are you a seasoned Pharmacovigilance Quality professional ready to shape global PV compliance, drive inspection readiness, and strengthen patient safety... ...development and execution of GVP audit programs, inspection...SeniorContract workRemote work
$217.6k - $326.4k
...Pharmaceuticals seeks a Senior Director of GCP Operational Quality... ...quality risk management and inspection readiness... ...outcomes and regulatory compliance. Responsibilities... ...strategies aligned with Global Clinical Operations,... ...quality governance, audit oversight, and vendor...Senior$225k - $337.5k
...oriented Head of Digital Strategy & Channels, Senior Vice President, to lead the firm's... ...outcomes.The successful candidate will lead a global organization of digital strategists, UX... ..., search specialists, product managers, and measurement experts.Build digital capabilities...SeniorFull timeTemporary workFlexible hours$185k - $235k
...Therapeutics is seeking a Senior Director Quality GCP to provide strategic... ...a risk-based GCP compliance program. Support teams... ...ensure compliant vendor management and regular assessment/audits. May conduct GCP audits... ...compliance with US and global regulations (FDA, EMA,...Senior$124k - $335k
...to clients on tax planning, compliance, and strategy. These individuals... ...to specific PwC tax and audit guidance), the Firm's code of... ...OpportunityAs part of the Global Information Reporting team you... ...our clients' needs. As a Senior Manager you are expected to lead large...SeniorFull timeH1b$247.5k - $357.5k
Job title: Global Head of Quality Audit and External LiaisonLocation: Remote, USAbout... ...launches and support compliance through quality audits, regulatory... ..., Good Clinical Practice (GCP), Good Clinical Laboratory... ...leadership and change management. Fluent English. Bachelors...Full timeRemote workWorldwide$171.2k - $256.8k
...Massachusetts.SummaryThe Director, GCP & GLP QA, reporting to the... ...programs to ensure compliance with GCP, GLP, and global regulatory requirements. This role oversees audit strategy and execution, vendor and CRO quality management, inspection readiness, quality...SeniorContract work$139.7k - $240k
...1Closes: 2027-10-21Job Summary:The GES Senior Manager is responsible for executing tasks relating... ...directly with general tax and audit engagement teams to provide compensation... ...generated outputs for accuracy, quality, and compliance.We are proud to be an ESOP company,...SeniorWork at office- ...Assurance to lead vaccine clinical support auditing and compliance for a prominent pharmaceutical client.... ...necessitates extensive experience in GCP and quality oversight for clinical... ...will have a strong background in project management and excellent communication skills to...
$217.6k - $326.4k
...Summary:The Sr. Director, GCP Operational Quality... ...proactive quality risk management across respective product... ...clinical quality, and compliance for assigned programs.... ...leadership and teams (e.g. audit, vendor management) in... ...stakeholders across Global Clinical Operations, Medical...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week- Takeda is seeking a Senior Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA to oversee regulation submissions and strategic regulatory activities for global marketed products. You will collaborate with GRL and regional leads to align with local requirements...SeniorLocal area
$227.9k - $308.3k
Overview:The Senior Director, Global Pharmacovigilance Quality Assurance... ...long-term regulatory compliance.This role can be... ...compliance risk management, quality metrics, trend... ...Owns the risk-based GVP audit strategy and PV... ...working knowledge of GCP interfaces is expected...SeniorFull timeTemporary workLocal areaRemote workFlexible hours$140k - $200k
Position Summary As a Senior GCP Technical Account Manager (Lead Cloud Integrated Infrastructure Engineer II), you will support Public Sector... ...recruiting process, please direct your inquiries to the Global Call Center (GCC) at ****@*****.***....SeniorLocal area$228k - $342k
...AnalyticsGeneral position summary:The Senior Director, Quality Data, Digital Systems & Compliance, serves as a pivotal... ...integrity, master data management, computerized systems... ...ALCOA+ principles and global regulatory expectations... ...experience (e.g., GMP, GCP, IT). Experience...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$124k - $280k
...refer to specific PwC tax and audit guidance), the Firm's code of... ...and external reporting. As a Senior Associate, you will mentor... ...highest standards of quality and compliance in all deliverables Deliver... ...analytics reporting, and data management Familiarity with Data...SeniorFull timeH1b$155k - $214k
...This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen... ...to the Director of Quality Risk Auditing & Governance, you will be the primary... ...summaries for governance forums and senior Quality leadership.Support risk escalation...Full timeTemporary workLocal area$95 - $135 per hour
...Title: Principal GMP Compliance Auditor Type: 6+ Month... ...Seeking a Senior Principal GMP Compliance... ...lead independent GMP audits across pharmaceutical... ...subject matter expert in global regulatory compliance,... ...documentation, and risk management. Support inspection...SeniorHourly payContract workRemote work- ...what we stand for as a firm.KPMG is currently seeking a Manager or Senior Manager to join our Global Mobility Services (GMS) practice.Responsibilities:... ...attached link contains further information regarding KPMG's compliance with federal, state and local recruitment and hiring...SeniorWork experience placementLocal area
- ...food safety programs, supplier controls, operational audits, crisis management, and regulatory compliance across all jurisdictions. The director partners... ...•Strong speaking skills in large group setting with Senior Level clients. Preferred Certifications •CP-FS...SeniorLocal areaRemote workFlexible hoursShift work
$250k - $273k
...most.We're seeking a Senior Director, Quality Compliance reporting to the VP,... ...the organization’s global quality compliance programs... ...supplier quality management program for CMOs,... ...qualification, auditing, performance monitoring... ...experience in GMP, GCP, and/or GLP environments...SeniorWork at office$230k - $281k
...Position Summary: The GCP Quality Assurance candidate will manage activities related to the... ...ensure both quality and compliance of company sponsored clinical... .../or assist in internal audits (systems, processes,... ...urgency in remediation to senior management. Perform program...SeniorContract work
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