Senior CSV Lead: ERP Validation & GMP Compliance
Katalyst-Healthcares-
JobDiva, Inc. in Norwood, MA seeks an experienced Computer Systems Validation expert to lead validation for the Moderna ERP platform (S/4, BTP, MDG). You will coordinate cross-functional teams to ensure regulatory expectations and robust validation across the lifecycle. The successful candidate will have 10+ years in GxP CSV, deep SAP validation expertise, and a proven track record in risk-based validation, traceability, and CAPA within manufacturing and supply chain projects. #J-18808-Ljbffr Katalyst-Healthcares-
- 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
- ...experienced Computer Systems Validation expert to lead validation and testing for the Moderna ERP platform (S/4, BTP,... ...validated state and compliance with GxP requirements.... ...Minimum 10 years of CSV experience within SAP... ...validating AI solutions in a GMP environment Experience...Senior
- ...LifeSciences is seeking a Supervisor, QC Analytical Laboratory to lead the analytical laboratory operations and ensure compliant... ...finished products. The role focuses on data integrity, method validation, and regulatory readiness. You will oversee lab activities, manage...Senior
$145.9k - $234.2k
...accuracy, traceability, and GxP compliance.Develop and maintain Scitara... ....Author and execute system validation documentation (URS, FRS, DS,... ...computerized system validation (CSV) and 21 CFR Part 11... ...we have aspired to build the leading mRNA technology platform, the...SuggestedPermanent employmentFull timeWork at officeWork from home$129k - $156k
...today, safer tomorrow. Emergent is a leading public health company that delivers... ....Job Summary The Sr. Engineer, Validation ensures cGMP regulatory compliance through adherence to site and corporate... ...Systems preferably used in a GMP environment.Read and interpret drawings...SeniorLocal area- ...to own the quality systems and regulatory compliance for a 175-person facility. You will... ...efficacy for FDA and state boards. You will lead audits, trainings, and regulatory interactions... ...team development to maintain top-tier GMP standards and ongoing improvements. #J-1...
- ...analytical CMC professional to provide executional support for method validation, transfer, and lifecycle management across late-phase and... ..., and help ensure regulatory readiness while operating in a GMP-regulated biopharma environment. The role emphasizes executional...Senior
- ...analytical development scientist to advance method development and validation for clinical-stage qualification and commercial readiness. The... ...in lifecycle management of analytical methods. Strong GMP experience and data interpretation are essential. #J-18808-Ljbffr...Senior
$50k
...collectively. The Validation SME, with Delivery... ...Mission - to be the leading provider of automation and compliance solutions across the... ...engineering experience in GMP regulated... ...or GMP CQV and CSV expertise with equipment... ...be eligible for Senior Leadership Incentive...Temporary workFor contractorsWork experience placementWork at officeWeekend work$212k - $333.19k
...to accelerate access to transformative medicines and make a lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory team. In this influential role, you will lead a top-priority...SeniorMinimum wageLocal areaRemote workWorldwide- ...The GMP Operational Quality Senior Manager is an advanced technical resource in the principles and application of quality assurance and compliance. This role coordinates or executes activities on multiple... ...Experience successfully leading event investigations, Root Cause...SeniorContract workShift work
$196k - $294k
...that make Klaviyo special.About the RoleKlaviyo is seeking a Senior Lead Product Manager to drive our Enterprise product strategy and... ...time personalization, and support global data governance and compliance.Collaborate deeply with Engineering, Design, Sales, Solutions...SeniorWorldwide$170k - $215k
...speculative investment bubbles and also as a leading climate investor and advocate.GMO is... ....Position Overview:GMO seeks to add a senior attorney to its Legal Team. The Senior Legal... ..., client retention, and regulatory compliance across U.S. and non‑U.S. markets. Over time...SeniorFull timeLocal areaWorldwideFlexible hours- We Are:Accenture is a leading solutions and services company that helps the world’s leading... ...core team working on a priority. At a Senior Manager level, it could include the following... ...in the MedTech industry focused on ERP technology strategy, design and delivery...SeniorFull timeLive inWork at officeLocal area
$196k - $294k
...make Klaviyo special. About the Role Klaviyo is seeking a Senior Lead Product Manager to drive our Enterprise product strategy and... ...time personalization, and support global data governance and compliance. Collaborate deeply with Engineering, Design, Sales,...SeniorWorldwide- ...Special Needs PreK-8 for our program. This full-time role involves leading instruction for students with autism, collaborating with a... ...Education with MA licensure in Moderate Special Needs, CPR/First Aid, and a valid driver's license. #J-18808-Ljbffr League School for AutismSeniorFull time
- ...Lawyer / Attorney / Counsel - Junior / Senior / Lead Boston, Massachusetts, United States About the Job Catalyst Labs is a leading... ...agency with a specialized vertical in Legal, Regulatory Compliance, and Corporate Governance. We operate deeply inside our clients...SeniorContract work
$77k - $202k
...ApplicableSpecialismData, Analytics & AIManagement LevelSenior AssociateJob Description & SummaryThe OpportunityAs a Data Validation Risk Senior Associate you will support client engagements in data and analytics engineering, focusing on data engineering work that helps...SeniorFull timeH1b- Role: Senior IT Business Analyst, GxP Systems EPM is... ...regulated GxP systems. Lead requirements gathering,... ..., implementations, and compliance initiatives. Support computerized system validation (CSV/CSA) efforts, including... ...systems, including GLP/GMP environments. Hands-on...Senior
- Job-ID32217193Reference26-00544Job Summary: Responsible for leading and maturing the Validation / Computer System Validation (CSV) program, ensuring compliance with GxP and FDA requirements. The role focuses on driving validation strategy, closing compliance gaps, supporting...
$228k - $342k
...position summary:The Senior Director, Quality... ...Digital Systems & Compliance, serves as a pivotal... ...Systems Compliance (CSA/CSV) oversight. The position promotes leading practices, supports... ....Govern validation/assurance methodologies... ...experience (e.g., GMP, GCP, IT). Experience...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$135.62k - $203.44k
...Location: Seaport, Boston or Gaithersburg, Maryland Reports to: Senior Director, Global Regulatory Strategy About Alexion For... ...transforming the lives of people living with rare diseases. We lead with breakthrough science, deep disease understanding, and a dedicated...SeniorTemporary workWork at office$109.25k - $149.5k
...standards of care.SUMMARYThe Lead Auditor, Quality Compliance will form part of the... ...compliance with recognized ISO, GMP, GDP, GCP, and GLP, global... ...with auditees and senior management while helping deliver... ...analysis, process validation, regulatory compliance, clinical...Full timeTemporary workWork experience placement$65 per hour
...Description The Sr. Specialist GMP QA Operations works with a... ...support of their function. The Senior Specialist completes work in a... ...with corporate goals and compliance with all regulatory requirements... ...pharmaceutical setting Proficient in leading event investigations Root...SeniorFull timeContract workTemporary work- ...Specialist I, Document Control to own the GMP document control program for the vaccine... ...controlled documents, ensure GDP/ALCOA+ compliance, and serve as the EDMS SME to support inspection... ...and regulatory alignment. You will lead doc control workflows, archiving, deviations...
- Job Summary We are seeking a Lead CSV / Validation Consultant (Director-Level) for a biotech client with an upcoming FDA inspection. This is a critical position focused on program maturity, SaaS validation, and audit readiness. Roles & Responsibilities Lead and mature the...
- ...Microbiology Laboratory in Massachusetts. You will lead testing activities, ensure regulatory compliance, and drive data integrity across environmental monitoring, validation studies, and investigations. The role requires extensive GMP/GLP experience, supervisory skills, and...
- Emergent BioSolutions in Canton, MA is seeking a Senior Bioprocess Associate to support GMP manufacturing of bulk drug substance and bulk drug product across upstream, downstream and final formulation stages. The role requires experience with GMP manufacturing, aseptic...Senior
$212k - $333.19k
...knowledge.Job DescriptionSenior Director, AIRx Discovery Biology Lead Takeda Research is constructing the Discovery Automation &... ...DAR) group.Accountabilities Own the disease biology and target validation strategy across the AIRx portfolio; ensure all programs have mechanistic...SeniorMinimum wageLocal areaRemote work- ...collaboration worldwide. You’ll work with leading companies across industries, helping... ...data engineering, analytics/AI, security/compliance, and operational readiness to unlock... ...during the calendar year. Job Title Senior Project Manager - Hybrid Cloud Date posted...SeniorFull timeContract workTemporary workPart timeRemote workWork from homeWorldwideShift work
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