Karyopharm Therapeutics Inc.

Senior GCP Auditor/Manager, GCP Audit

Job Locations US-MA-Newton
Job ID
2020-1635
# of Openings
1
Category
Quality & Regulatory Affairs
Type
Regular Full-Time

Responsibilities

The Senior Quality Aduitor/Manager of GCP Quality. 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, and of clinical trial sites.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  in other departments, particularly Clinical Operations, in a collaborative nature as a QA on regulatory topics and interpretations. Strong communication skills , the ability to build internal and external relationships including interactions with clinical investigators and their staff concerning GCP matters, contract research organizations, and clinical laboratories.

 

Essential Duties And Responsibilities

  • Control document lifecycle activities, including biennial review of procedures and document retention.
  • Performs verification and auditing of data generated during the conduct of a clinical study ensuring compliance with standard operating procedures and regulatory requirements
  • Assist with the development and implementation of a Clinical Quality Oversight program to include clear processes and procedures for executing appropriate quality support during clinical trials
  • Assist with providing FDA, EMA, and ICH guidance to support project teams in maintaining compliance and awareness in preparation for agency inspections
  • Develop audit schedules and conduct/coordinate global GCP audits including Part 11, Clinical and Pre-Clinical Data Management/Stats, clinical and non-clinical trial audits
  • Evaluation and review of clinical trial deviations to ensure appropriate investigation has been conducted, documented and corrective measures implemented to prevent future occurrences
  • Support coordination and management of GCP-related inspections by Regulatory Authorities, including pre-inspection activities and BIMO inspections. Participate in the preparation of responses to external regulatory inspections
  • Reveiw and approve clinical trial protocols and associated documentation (including, but not limited to Patient Information Letters, Informed Consent Documents, Patient Questionnaires, CRFs, etc.), as appropriate, to ensure compliance with relevant standards/regulations
  • Drive the implementation of integrated and comprehensive data-driven Quality Assurance activities, procedures and policies to ensure compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness.
  • Summarize Quality activities, trends and areas of potential risk to Leadership and Clinical Team(s)
  • Actively participate and collaborate with Clinical Teams globally
  • Perform other duties as required.

Qualifications

Qualifications

  • Bachelor’s degree in Biological Science or related field.
  • Minimum of five (5) years experience in Biotechnology, Phramaceutical or CRO (must have been part of Quality, Compliance, or Regulatory department)
  • Five (5) or more years related experience of Quality review of clinical study data, including experience with reviewing SAS datasets, clinical study reports (CSR), Case Report Forms (CRF) and data listings in the biopharmaceutical or pharmaceutical industry
  • Preference to CCRP, ACRP, CPMA or equivalent certification
  • Strong understanding and application of GCP and ICH regulations and guidance documents
  • Will support highly complex and unique issues where analysis of situations or data requires an evaluation of intangibles. Strong ability to compose clear and concise communications with an astute attention to detail.
  • Must possess professionalism and ability to effectively interact and communicate with internal staff and management as well as with external CRO and regulatory bodies
  • Can operate independently and able to identify observations and/or gaps in clinical relevant areas
  • Able to learn new computer systems / programs quickly
  • Excellent organizational skills and attention to detail
  • Bachelor’s of Science degree or equivalent

Overview

Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

 

Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer.  All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law.  Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities.  If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.

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