Senior Program Manager, CCS, QA

Location: Cambridge, Massachusetts Salary: competitive
Sector: Pharma & Biotech, Quality & Supply Chain, Engineering & Validation, Clinical Research, R&D, Quality Assurance (QA), Pharmacovigilance, Regulatory Affairs Type: Contract

Job title: Senior Program Manager, CCS, QA

Reports to: Director, Clinical Compound Support, Quality Assurance program

Location: Cambridge, MA

Contract duration: 12 Months

Compensation: Competitive

Responsibilities of Senior Program Manager, CCS, QA

  • Lead and influence clinical compound support QA Program Managers
  • Lead investigator, vendor, facility and system audits in compliance with SOPs, ICH and local regulatory guidelines, on a domestic and international basis
  • Manage investigations into scientific misconducts and/or serious breach of GCP
  • Develop and maintain a strategic quality plan for assigned compounds
  • Manage programs of high complexity and/or risk, and provide appropriate risk analysis
  • Serve as a strategic GCP quality resource, including assisting during regulatory inspections
  • Maximize efficiency and effectiveness in use of available resources

Required qualifications of Senior Program Manager, CCS, QA

  • B.S. in science, nursing or related scientific field
  • 7+ years of experience in the pharmaceutical and biotechnology industry
  • Advanced knowledge in the conduct and reporting of audits
  • Ability to create corrective action plans mitigating risks to the company, safety and data integrity

Desired qualifications of Senior Program Manager, CCS, QA

  • Oncology experience
  • Risk Mitigation experience
  • ASQ Certified Quality Auditor, or Certified Manager of Quality/Organizational excellence
  • SQA Registered Quality Assurance Professional
  • GCP certification

Requirements of Senior Program Manager, CCS, QA

  • Willingness to travel about 30%
  • Ability to work on-site in Cambridge, MA

As a temporary W2 employee of Real Staffing, you have the option of enrolling into the following offered benefits: medical, dental, vision, 401K, voluntary short/term long term disability, and voluntary life insurance.

Sthree US is acting as an Employment Business in relation to this vacancy.