- Repligen (Waltham, MA)
- …processes, and supporting strong analytical approach with teams across the organization. Internal Controls & Compliance :Design, implement, and maintain ... internal controls over financial reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure compliance with accounting standards and… more
- Formation Bio (New York, NY)
- …process end-to-end within Zip, including ensuring coding accuracy, proper PO matching, and compliance with internal controls Administer Navan for travel and ... employee reimbursements, system configurations, user onboarding/training, and coordination with internal stakeholders Perform monthly bank reconciliations and support other… more
- Merck & Co. (Rahway, NJ)
- …technical integration, assembly automation, etc.), as well as members of internal cross-functional product development teams from concept through product launch. The ... and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Aequor (Tampa, FL)
- … with tax regulations and company policies. Withholding Tax and Tax Treaty Compliance Execute and oversee controls to verify the correct application of ... tax provisions, and manage tax balance tracking accurately. Supervise monthly e-invoicing controls to ensure compliance and accuracy. Forecasting and Cash Flow… more
- Repligen (Waltham, MA)
- …quarterly close processes and ensures compliance with US GAAP and internal control requirements (SOX). This position supports general ledger accounting, ... including SEC filings support (10-Q, 10-K)Maintain documentation to support SOX internal control complianceParticipate in audit requests from internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …applicable Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and ... role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from...drift in external vendor and NNI processes to mitigate non- compliance and deviation occurrence Support internal and… more
- Merck & Co. (Rahway, NJ)
- …assessments across all our company's divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value to the area ... knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex business scenarios in accordance with… more
- Tris Pharma (Monmouth Junction, NJ)
- …supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory agency ... procurement policies and procedures throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement… more
- Merck & Co. (Millsboro, DE)
- …corporate and regulatory policies.Review production records for completeness and compliance to departmental and/or Site Standard Operating Procedures (SOPs).Provide ... projects with a high level of technical difficulties and internal constraintsScheduling and planning for department requirementsCoordinate with department personnel… more
- Merck & Co. (Rahway, NJ)
- …investigations with a strong focus on quality and regulatory compliance .Excel in impurity isolation, unknown peak identification, characterization of degradation ... as mass spectrometers and other spectroscopic techniques.Collaborate closely with internal company sites and Contract Manufacturing Organizations (CMOs) within the… more
- Merck & Co. (Rahway, NJ)
- …mitigate risks, and continuously enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve ... while coordinating with impacted company sites and External Partners.Collaborate with internal teams to ensure seamless product supply with an end-to-end… more
- Formation Bio (New York, NY)
- …large molecule programs from early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a ... seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to biologic product development at Formation Bio.… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control ... well as test methods and proceduresPrepares CCRs, according to change control processCoordinates, advances and monitors progress for all required documentations and… more
- Eisai, Inc (Raleigh, NC)
- …The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. This ... quality assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to resolve quality-related issues.Key responsibilities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support ... the delegate for the Head of Operations.Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within… more
- Repligen (Waltham, MA)
- …Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the QMS including ... but not limited to Internal and External Auditing, Nonconforming... and External Auditing, Nonconforming Materials, CAPA, Validation, Change Controls , and other product life cycle management activities.Partner with… more
- Twist BioScience (South San Francisco, CA)
- …technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the full Software Development ... and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation: Ensure our custom MES solutions comply with… more
- Merck & Co. (Rahway, NJ)
- …environment that provides substantial technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages ... expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal… more
- Merck & Co. (Durham, NC)
- …and implementation of any new projects.- This includes SME support during routine internal and external GMP and Financial audits, QSAT actions, to ensure ... compliance .- This is a fast-paced and multi-faceted role that...and coaching to ensure team success.SME support during routine internal and external GMP and Financial audits, input to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to identify market trends, leading a high-performing team while ensuring compliance with legal standards. The Director will drive informed decision-making and ... Relationships Reports to the VP, Enterprise Insights. Has responsibility of cultivating internal and external relationships that bring value and insights to the… more
