company logo

Senior Manager, GCP Quality at Karyopharm Therapeutics in Newton, MA

Save

compensation:

$80K — $100K *

specialty:

Quality Management

experience:

5 - 7 years

Job Description

Responsibilities

Senior Manager, GCP Compliance will be a critical team member who contributes to implementation of risk-based GCP and compliance oversight. This person will be responsible for the planning, identification, coordination, execution, reporting and closure of CGP Compliance issues in support of clinical programs. The incumbent is also responsible for supporting the GCP auditing plan and assisting its management.

  • Conduct Regulatory Submission Review such as Investigator Brochures (IB), Development Safety Update Report (DSUR), Clinical Study Reports (CSRs), NDAs, Clinical Protocols, ICFs.
  • Conduct/Lead Internal System, process and documentation Audits to ensure compliance to the Code of Federal Regulations, the International Conference of Harmonization (ICH), applicable regulations and company SOPs.
  • Conduct qualification or routine vendor audits of Clinical Research Organizations, Clinical Laboratories, Phase I Units, Imaging Vend
See More

Valid through: 7/7/2020

About Karyopharm Therapeutics

Total Jobs:
28
Average Pay:
$158,387
Total value of jobs:
$4,910,000
% Masters:
50%
Learn More About Karyopharm Therapeutics
* Ladders Estimates

More Jobs at Karyopharm Therapeutics

Similar Jobs

More Pharmaceuticals & Biotech Jobs

Senior Process Engineer - Skin Substitute Therapeutics

$180K — $225K + $120 hourly

Confidential Company

Boston, MA 02110

Today

Sales Manager-Chain Drug

$130K — $150K + $13K—$15K bonus + 15% company paid ira, full medical for family

Yesterday

Environmental Health & Safety Manager

$80K — $90K

Confidential Company

Waterloo, IA 50704

3 days ago

Find similar senior manager, gcp quality jobs: