GMP Quality Senior Specialist: Release & Compliance Lead
Vertex Pharmaceuticals
Vertex Pharmaceuticals LLC is seeking a Senior Quality Specialist (1st Shift) for on-site work in Boston to lead QA activities in support of clinical and commercial Drug Product manufacturing. You will review batch records, approve CoAs, and ensure proper disposition and labeling while archiving essential documents in eDMS.
The role emphasizes collaboration, audit readiness, and continuous improvement. The position requires leadership of cross-functional teams, strong GMP knowledge, and
#J-18808-Ljbffr$60 - $65 per hour
...Job Description The Senior Quality Specialist (1st Shift) is... ...quality assurance and compliance. The Senior Quality Specialist... ...coordinates GMP activities in support... ...process data, EM data, QC release testing and other... ...success by independently leading cross-functional...SeniorContract workWork experience placementShift workDay shift$65 - $70 per hour
...Job Description The GMP Operational Quality Senior Specialist Contractor supports the principles... ...assurance and regulatory compliance. The incumbent supports... ...to support on time release deliverables Conducts... ...setting Proficient in leading event investigations, Root...SeniorContract workTemporary workFor contractors- Judge Group, Inc. is seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across pharmaceutical sites, laboratories, suppliers, CMOs, and quality systems. This role focuses on regulatory compliance, inspection readiness, and quality-system effectiveness...SeniorRemote job
- ...Vertex Pharmaceuticals LLC in Boston, MA is seeking a Senior Quality Specialist (2nd Shift) to lead QA activities ensuring GMP compliance for clinical and commercial Drug Product manufacturing and disposition. The role covers review of batch data, approvals of CoAs, labeling...SeniorAfternoon shift
$55 - $60 per hour
...Technologies Inc. Title GMP Operational Quality Senior Specialist Employment Type Contract... ...product disposition, and compliance while supporting cross-functional... ...review Support product release, COAs, change controls,... ...Demonstrated success leading cross‑functional teams Compensation...SeniorHourly payContract work$95 - $125 per hour
...Description: Title: Principal GMP Compliance Auditor Type: 6 Month Contract... ...domestic and international Seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across... ..., suppliers, CMOs, and quality systems. This role serves as a subject...SeniorHourly payContract workRemote work- Moderna is seeking a QC Raw Material professional to perform release and inspection activities for GMP manufacturing. The role emphasizes cGMP documentation, risk assessments, and collaboration with internal and external labs on methods like HPLC and TruScan. Responsibilities...SeniorShift work
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- ...Summary: The Operational Area Senior Quality Specialist will provide QA support of... ...in-process data, EM data, QC release testing and other quality systems... ...QA support and oversight of GMP manufacturing operation Experience successfully leading event investigations, Root...SeniorWork at office
- ...Summary: The Operational Area Senior Quality Specialist will provide QA support of... ...in-process data, EM data, QC release testing and other quality systems... ...QA support and oversight of GMP manufacturing operation Experience successfully leading event investigations, Root...SeniorWork at office
- ...Only Key Responsibilities: Lead and support quality activities including deviations... .... Review and approve GMP documentation, procedures and... ...quality records. Support batch release, product quality and... ...and QA teams to ensure GMP compliance. Provide guidance on quality...SeniorHourly payContract work
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$159.8k - $239.8k
...DescriptionThe Associate Director of GMP Operational Quality Assurance is an advanced... ...of quality and regulatory compliance. The individual adapts to... ...Quality Escalation Lead (QEL), Escalation Action Committee... ..., strategy for GMP release and disposition strategyEstablish...Full timeContract workWork experience placementSummer work- ...Vertex Pharmaceuticals in Boston seeks a GMP QA Analytical Sr. Quality Specialist to serve as a subject matter expert in QA and compliance for the Analytical function. The role supports... ..., accurate quality decisions. This senior specialist conducts GMP reviews, helps...Senior
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- ...Vertex Pharmaceuticals is seeking an Associate Director, GMP Operational Quality Assurance to lead strategic and operational QA across programs. You will... ...disposition, ensuring patient safety and regulatory compliance. Collaborate with Product Quality Leads, MSAT,...Senior
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- ...Associate Director, QC Technical Services – Small Molecule, to lead a team responsible for GMP release and stability testing at external laboratories supporting commercial programs. You will drive compliance, performance metrics, and cross-functional collaboration to...Senior
- ...A leading biotechnology company in Cambridge, Massachusetts, is seeking a Sr. Manager, IT Omnichannel Techno... ...delivery of MarTech capabilities within a SAFe Agile Release Train, translating marketing, data, and compliance needs into actionable solutions. The ideal...Senior
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$212k - $333.19k
...lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA)For the project...SeniorMinimum wageLocal areaRemote workWorldwide
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