- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for ... leading a global team focused on R&D Quality . This global role includes direct reports in the...compliance with applicable regulations and guidelines that ensure sustained GCP /QSR compliance. + **Vendor Management:** Leads and develops systems… more
- Bausch + Lomb (Trenton, NJ)
- …(eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance , Pharmacovigilance/GPSS and Drug/Device Safety, and ... study objectives are being met and provide the operations director and/or senior management with timely updates on progress...GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,… more
- Sanofi Group (Morristown, NJ)
- …that leverage digital technologies for advanced research opportunities. **Compliance and Quality Assurance ** + Accountable for ensuring all evidence generation ... **Job title** : Global Medical Director , Evidence Generation - Innovation & Partnerships **Location:**...), and company policies. + In charge of implementing quality assurance processes to maintain the integrity… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …quality capabilities, enhance process improvements and transparency. This is a quality assurance role, helping maintain global compliance, reinforcing audit ... Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within… more
- Bristol Myers Squibb (Madison, NJ)
- …* Ensures high quality and timely delivery of protocols and data; implements quality assurance plans * Maintains an advanced understanding of the status of ... This position leads a team and a complex scope of work to ensure high quality delivery of innovative protocols and data packages for CSRs and Regulatory Filings. The… more
- Ascendis Pharma (Princeton, NJ)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits. . Functions as a patient ... all safety reports received from any source are reviewed according to ICH- GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with… more