GCP Auditor / Clinical QA at Cambridge

Job Description

Title: GCP Auditor / Clinical QA

A growing Oncology company in greater Boston is hiring clinical QA specialists / GCP auditors!  Having recently received approval for our first drug we are expanding operations including additional research.  We are looking for Clinical QA specialists and GCP auditors to join our team to assist in the further development of our pipeline focused on cancer therapies.  If you are looking for a company that is making headway in creating better lives for cancer patients keep reading.

The Clinical QA Auditor - will conduct internal and external audits and assist with audit program management to assure adherence to relevant global markets regulations, guidelines, and company procedures.

DUTIES AND RESPONSIBILITIES

• Assist in developing/maintaining SOPs for the management and oversight of GCP activities.
• Assist in developing and managing GCP audit plans for assigned projects/products.
• Assess compliance of clinical investigator sites, vendors, and company programs to FDA, ICH, and other government agency regulations/ guidelines.
• Audit clinical trials including clinical investigator site audits, clinical vendor audits, directed audits, and other special audits and assessments to assess quality level and compliance with applicable GCP regulations in support of clinical trials.
• Report results to project team personnel and management, and interact with various teams to ensure corrective actions are taken and to bring audit observations to closure
• Participate in special assignments on various projects (including inspection readiness) as determined by QA management.
• Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.

Job Requirements

• At least 5 years of relevant pharmaceutical industry experience, including at least 3 years of GCP audit experience.
• Thorough knowledge of ICH Guidelines and GCPs including regulatory requirements for the conduct of clinical development programs.
• Excellent oral, written and verbal communication skills.
• Appropriate technical skills in GCP compliance.
• Proven interpersonal skills.
• Ability to travel at least 50% of the time (Europe & the Americas).
• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

Country: USA, State: Massachusetts, City: Cambridge, Company: MR - Klein Hersh International.