- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and external audits as SME for department and respond to audit observations. Lead technical reviews, investigations, and process improvement projects.Identify, ... tasks.Develop the performance/talent of direct reports.Schedule, staff, train, and audit multiple activities for responsibilities.Ensure completion of all testing,… more
- Merck & Co. (Rahway, NJ)
- …to what is described in the Pipeline Advertisement.Expand your skills and experience in audit through a career path in the pharmaceutical industry. Become part of a ... impact on patients' lives.Under the direction of the Client Audit Director (CAD) and the Auditor-in-Charge (AIC), the Senior...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, NJ. Role Overview ... The Quality Compliance- Lead Auditor CAR-T is responsible for regulatory compliance supporting...support the implementation, execution, and improvement of the internal audit process. Support the planning and execution of internal… more
- Merck & Co. (Rahway, NJ)
- …due diligence has been carried out, and the solution is audit /inspection ready, if applicable.Collaborate with stakeholders to understand and anticipate their ... resolution, and encourage an organizational culture, which promotes behaviors that lead to meaningful synergies and superior business performance to create value… more
- Catalent (St. Petersburg, FL)
- Supplier Quality Regional Lead Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ... of the Global Supplier Quality Management team, the Supplier Quality Regional Lead will be responsible for management and leading the Supplier auditors performing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Manufacturing Lead Operator as part of the Technical Operations team based in Raritan, ... to develop professionally. Support investigation efforts as required. Responsible for audit preparation and participation. Requirements HS Diploma required with 8-10… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... Partner with global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit documentation.- Author, update and maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to support Clinical Inspection Readiness (IR) and ... the scrutiny and questioning of a sponsor pre-approval inspection.Post inspection, audit , quality review, investigational panel or other identified sources, gather,… more
- Eisai, Inc (Nutley, NJ)
- …incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and track KPIs.Define ... compliance issue resolution.Report compliance risk levels to key stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GDP requirements, risk-based assessment for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits are planned, ... communicated and that audit targets for tactical and strategic GVP audits are...and Specialty Medicine portfolios, in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness,… more
- Catalent (St. Petersburg, FL)
- …and oversight. The Quality Auditor will be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are completed ... for organizing and performing the audits assigned and to develop a planned audit schedule to maximize audits conducted during one trip ie, grouped audits based… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path ... for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical Study Oversight Plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including critical ... and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross functional Clinical Study Oversight… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the ownership and maintenance of GCO-owned procedural document packages. Lead authoring, review, and periodic reviews/updates for all GCO procedural ... appropriate, provide support for GCO process improvement activities, projects, inspections and/or audit findings resulting in the need for either a new procedural… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in ... safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in support of benefit… more
- Catalent (Philadelphia, PA)
- …for "Good Manufacturing Practices" and "Good Distribution Practices"Act as lead investigator for all compliance issues regarding incoming, distribution, returns, ... and revise SOPs/Forms, Distribution Summaries/Checklists, and Returns Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory, and… more
- Aequor (Thousand Oaks, CA)
- …Details: Owns and Manages Change Control Records. Owns and Manages Deviations, and Lead Root Cause Analysis. Develops, writes, edits, and formats materials such as ... manage change control records Own and manage minor and major deviation records and lead root cause analysis sessions Own and manage CAPA and CAPA EV records,… more
- Catalent (St. Petersburg, FL)
- …deliver solutions. Furthermore, this position will participate in the internal audit program, customer audits and may assist with Supplier Audits/Certification ... when production events occur as defined by SOP and lead cross functional team to classify events and deviations...Proven ability to multi-task and demonstrate diplomatic skills.Ability to lead othersSkilled at leading groups (eg Kaizen events or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support for data integrity assessments within the laboratory. Take the lead in managing Equipment Lifecycle Management processes, including overseeing change control ... Operating Procedures (SOPs) for equipment operation. Conduct regular reviews of system audit trails / periodic review to ensure data integrity and compliance. Manage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …site personnel as needed- Study-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical monitoring- For studies ... needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
