Senior Manager, Global GCP Audits & Compliance
Takeda Pharmaceutical Company Limited
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, and champions process improvements, with a focus on cross-functional collaboration and risk mitigation within a dynamic, matrixed organization. #J-18808-Ljbffr Takeda Pharmaceutical Company Limited
- ...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...Senior
- 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
$137k - $215.27k
...assurance oversight of the global clinical research... ...risk-based program audit strategy, ensuring... ...quality and compliance risks to key stakeholders and Management and appropriate and... ...Provide expertise in GCP compliance interpretation... ...solutions to senior management for immediate...SeniorMinimum wageWork at officeLocal areaImmediate startNight shift- ...Quality Assurance (CQA) to oversee GCP QA across Centessa-sponsored... ...to Late Phase. This role ensures compliance with ICH, global regulations, Centessa SOPs, and inspection... ...candidate will lead QA programs, audits of sites and vendors, manage CAPAs, and partner with cross-...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- ...providing Quality oversight of the global post-marketing... ...development and execution of the GVP audit program as well as... ...Summary of Key Responsibilities: Senior Manager, PV QA supports all the GVP... ...system, including ensuring compliance with GVP regulations. This includes...SeniorWork experience placementRemote workWorldwide
- ...Chiesi Global Rare Diseases in Boston, MA seeks a Senior Manager, HIDO Global Strategic Insights to lead market trends analysis and strategic decision support for Rare Diseases brands. The role is global in scope, with responsibilities spanning data collection strategy...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
$200.68k - $215.27k
...following job opportunity: JOB LOCATION: Cambridge, MA POSITION : Senior Manager, Global Regulatory Affairs, Marketed Products POSITION DESCRIPTION... ...submissions are provided to local company affiliates in compliance with local regulations and to maintain compliance for...SeniorMinimum wageFull timeWork at officeLocal areaRemote 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
$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$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- ...biopharma's clinical and nonclinical programs to ensure compliance with GCP, GLP, and GCLP standards. This role leads audits of CROs, laboratories, and investigator sites domestically and internationally, manages quality events, deviations, and CAPAs, and reviews key study...Senior
$212k - $333.19k
...Job Description Join Takeda as the Global Market Access Strategy, Franchise Head out... ...pipeline, launch and major lifecycle management opportunities. Shape and execute global... ...influencing skills, with the ability to align senior leaders without direct authority....SeniorMinimum wageFull timeWork at officeLocal areaRemote work- ...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...
$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...SeniorTemporary 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- ...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
$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$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$266k - $344k
...Job Summary The Senior Director, GCP Quality Assurance provides... ..., and reported in compliance with applicable regulatory... ...policies, and global GCP standards while maintaining... ..., Data Management, Biostatistics, and external... ...vendor oversight, audit strategy, inspection...SeniorLocal areaNight shift2 days per week$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- ...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
$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$135k - $155k
Senior Clinical Implementation Manager (East) Beacon Biosignals is transforming precision medicine for the... ...outcomes. You adhere to all regulatory, compliance, quality, and privacy standards... ...SaMD), including HIPAA, and support audits, documentation, and quality...SeniorContract workFor contractorsWork experience placementWork at officeRemote work$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
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