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GCP Auditor

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Cambridge, MA
$95,000 - $125,000
Job Type
Direct Hire
Mar 24, 2016
Job ID
Job Description

We are a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia inducible factor, or HIF, biology and the commercialization of these products for patients with kidney disease. We are developing our lead product candidate, AKB-6548, to be a best in class HIF-PH inhibitor for the safe treatment of anemia secondary to CKD. AKB-6548 has successfully completed a Phase 2a proof of concept study and is currently completing Phase 2b. Following its IPO in March 2014, the company is preparing for expansion to support global phase 3 programs.

Looking for an experienced GCP Auditor. The position will be responsible to assess compliance with ICH and US FDA regulations and guidelines, and clinical study protocols. Responsibilities include performing audits; internal systems, supplier, and of clinical trial sites. Audit findings are required to be summarized in a written report format according to SOPs and monitored for appropriate resolution. Audit findings are presented in an objective professional format, to the auditee. This role participates in the development, implementation and maintenance of the corporate GCP Quality Management System and training program. This is a cross functional position that works with personnel in other departments, particularly Clinical Operations, in a collaborative nature as an internal consultant on regulatory topics and interpretations. Strong communication skills (written and verbal), with the ability to build internal and external relationships including interactions with clinical investigators and their staff concerning GCP matters, contract research organizations, clinical laboratories and other clinical suppliers.

Required Skills
  • Understand the drug development process
  • Assure Corporate compliance with SOPs and GCP regulations
  • Have the ability to lead and coordinate diverse audit teams
  • Perform internal system, supplier, and clinical trial site audits
  • Accountable for accuracy of audit findings
  • Conduct follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution
  • Read, understand, interpret, and apply regulations, guidance documents, study protocols, and clinical trial materials
  • Participate in solving GCP compliance issues within  Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs , Pharmacovigilance
  • Coordinate joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards.
  • Maintain a working knowledge in the specific areas related to GCP compliance including, but not limited to regulatory US FDA regulations/guidance documents and ICH guidelines
  • Maintaining all associated department spreadsheets, tracking of audit findings, and audit files as applicable
  • Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions).
  • Assist in pre-qualification, and routine compliance audits of clinical suppliers (phase 1 units, IRBs, translators, depots, etc.)
  • Assist in development and implementation of pre-approval inspection readiness plans at investigative sites.
  • Assists senior staff during regulatory inspections
  • Serve as a resource regarding interpretation and application of quality requirements, concepts, and industry best practices 
  • Prepares required documentation to support audit activities including; audit plans, audit    reports, audit certificates and corrective action plans
  • Represents QA department at investigator meetings and CRO training programs/kick off meetings
Required Experience
  • Bachelor's degree in science or equivalent, with 5+ years of experience in conducting GCP Audits (QA experience in the Pharmaceutical industry required) Excellent knowledge of GCP regulations
  • A strong understanding of GCP regulations and an ability to apply them to clinical research and/or related processes is required
  • Inspection experience in hosting or supporting regulatory authority inspections (US FDA, Health Canada, EMA, MHRA)
  • Experience in auditing for compliance of computer system validation (CSV), pharmacovigilance systems, Good Clinical Practice, Central Laboratories and nonclinical GLP is highly desirable
  • Excellent technical writing skills
  • Strong Communication skills (written and verbal), interpersonal and problem solving skills and detail oriented
  • Domestic, international overnight travel is required