R&D Quality Mgr. | B5 | III - USA
Apply NowCompany: Saviance
Location: Cambridge, MA 02139
Description:
Associate Director, M&A Integrations Quality
Cambridge, MA
Pay range: *** - *** - based on skills and qualifications
Mergers and Acquisitions Intergration Quality support
- Review preclinical IND submission - relevant study reports (Pharmacology, Pharmacokinetics / DMPK, Toxicology) at general level
- Review IND submission materials - modules, IB, Health Authority communications, etc.
- Baseline audit support (Quality systems, Vendor management) of a deal partner company, and Data Integrity review. Client auditors will lead.
- Data and sample mapping at deal relevant CROs - regulated and non-regulated. Electronic, paper, pathology slides etc.
- Facilitate (with Client IT) data transfer to relevant Client systems. Study data, Electronic Notebooks, Analytical testing results, etc.
- Maintain risk logs and escalate / remediate issues as necessary
- Collaborate with relevant Client functions (preclinical safety etc.) to perform Source Data Verification and audit trail reviews.
- Prepare reports and summaries
Experience: 10 years with B.S., 7 years with M.S., 3 years with Ph.D.
Education: B.S or higher in Life Sciences, Bioengineering, Regulatory / Compliance, Biomedical
Skills: a) Scientific / technical laboratory-based studies generating data and reports b) General drug discovery/ development c) Team work in matrix environment d) General understanding of Biopharma regulations (GLP, GCP, GMP)
Hybrid with 2 days on site monthly minimum
Cambridge, MA
Pay range: *** - *** - based on skills and qualifications
Mergers and Acquisitions Intergration Quality support
- Review preclinical IND submission - relevant study reports (Pharmacology, Pharmacokinetics / DMPK, Toxicology) at general level
- Review IND submission materials - modules, IB, Health Authority communications, etc.
- Baseline audit support (Quality systems, Vendor management) of a deal partner company, and Data Integrity review. Client auditors will lead.
- Data and sample mapping at deal relevant CROs - regulated and non-regulated. Electronic, paper, pathology slides etc.
- Facilitate (with Client IT) data transfer to relevant Client systems. Study data, Electronic Notebooks, Analytical testing results, etc.
- Maintain risk logs and escalate / remediate issues as necessary
- Collaborate with relevant Client functions (preclinical safety etc.) to perform Source Data Verification and audit trail reviews.
- Prepare reports and summaries
Experience: 10 years with B.S., 7 years with M.S., 3 years with Ph.D.
Education: B.S or higher in Life Sciences, Bioengineering, Regulatory / Compliance, Biomedical
Skills: a) Scientific / technical laboratory-based studies generating data and reports b) General drug discovery/ development c) Team work in matrix environment d) General understanding of Biopharma regulations (GLP, GCP, GMP)
Hybrid with 2 days on site monthly minimum