Job title: Internal Audit Manager (Pharmaceutical) Location: Cambridge, MA, Bridgewater, NJ-Hybrid 3 days in Office.... Reporting to the Chief Executive Officer and the Audit Committee, the mission of Sanofi Internal Audit (SIA) to provide...
Job Description General Summary: The Internal Audit Manager will identify risk areas, evaluate business process... to perform data analytics, SOC1 reviews Obtain and provide training to the audit staff to support all aspects of Internal Audit...
· JOB TITLE: Manager/Sr. Manager, Documentation and Training REPORTS TO: Associate Director, Quality SystemsDATE... PREPARED: May 5, 2025 JOB SUMMARY: The Documentation and Training Manager is responsible for the development...
Development Operations, R&D Line Manager: (Senior) Clinical Project Manager or Clinical Program Director Location of the role... § Performing QC checks on TMFs to ensure completeness and readiness for audit/inspection § Contributes to clinical trial excellence...
of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate... Operations organization responsible for internal commercial operations in support of GMP manufacturing and testing activities...
strategies across third parties, affiliates, strategic business partners and internal vendor management. This role requires... about vendor risk that inform audit planning, inspection readiness, and governance strategies employed by quality counterparts...
Quality Compliance and Systems, Senior Manager is responsible for ensuring the quality of processes and product outputs... of processes or outputs against defined internal and regulatory standards, contributing to Takeda's mission of delivering quality...
), Public Affairs, Commercial Legal, Payer Accounts, Trade & Distribution FP&A, Accounting, Internal Audit etc. to ensure... the highest levels of performance and commitment to their professional development Work with internal functions...
, including internal staff and external vendors, ensuring compliance with medical information services and the review and approval... & Ethics (OBIE) to ensure all systems are compliant and audit-ready. 6. Analytics and Insights: Lead an analytics team...
, Root cause analysis and CAPAs, as well as developing and communicating department QMS metrics and leading internal Tier..., MA-02210. Monday to Friday. Key Duties and Responsibilities: Collaborate with internal and external business partners...
monitoring/auditing plan for compliance with internal data protection policies and processes and working with Internal Audit... advice to a broad spectrum of internal clients on worldwide regulatory issues related to the processing of personal data...
in collaboration CDMOs Engage in Quality-to-Quality Meetings Collaborate with internal and external partners to resolve complex... risk mitigation plans as necessary Supports audit and inspections at CDMOs; ensures proper and timely CAPA...
for data analytics being one example) Work closely with Information Security, Internal Audit and Quality Assurance groups... Biotech or pharmaceutical industry experience Strong background in Enterprise and SOX systems and/or business processes...
records are maintained in a compliant and audit-ready manner. Lead or support internal and external audits related... is also responsible for the development and maintenance of relationships with the internal and external partners, to drive compliance...
include counseling on deviations, internal monitoring and audit activities, corrective action plans, global reporting... in the context of an evolving and complex external regulatory environment Conceptualizes, designs, and deploys internal...
management and run services of our 50+ websites and the managed service partners and internal partners supporting these sites... of website development and the teams supporting them. Frequently audit and optimize SEO and digital marketing performance...