Search Jobs

Your NEXT GREAT OPPORTUNITY is within reach!

Manager/Sr. Manager, GCP Quality Assurance

Cambridge, Massachusetts 02142

Post Date: 02/22/2018 Job ID: 1821 Job Category: Clinical: Quality

The Manager/Sr. Manager GCP Quality Assurance, is responsible for monitoring and evaluating the compliance of clinical studies and client oversight of studies to FDA and International regulations and guidelines, as well as corporate policies and standard operating procedures.

Job Responsibilities:
  • Plans, conducts and reports on GCP audits of clinical investigators, vendors and systems plus key reports and documents
  • Participates in cross-functional teams providing guidance and risk based options
  • Reviews study documents and checks for consistency and appropriate standards and practices
  • Supports the internal audit process with regards to documents and compliance
  • Provides support during regulatory inspections and internal audits
  • Assists in the creation and maintenance of audit tools
  • When appropriate, prepares and/or revises GCP SOPs and Work Instructions
  • Represents GCP QA on appropriate teams to facilitate audit planning
  • Supports comprehensive internal GCP training programs
  • Works with cross-functional teams to provide GCP advice
  • Receives guidance from GCP QA senior colleagues and management
  • Coordinate audits, including external vendors, trial master file, clinical investigator sites, clinical documents and other internal systems.
  • Maintains and track Clinical CAPAs to ensure timely CAPA activities remediation and completion.
  • Maintain a work environment focused on quality, fostering respect, open communication, collaboration and teamwork.
  • Maintains good working relationships and communication with GCP customers and GxP QA audit staff
  • Partner with the Clinical Department, Drug Safety, Supply Chain and Commercial Operations to ensure all clinical trials are assessed for compliance with SOPs, FDA and other applicable regulations, and ICH/GCP guidelines.
  • Ability to travel up to 30% per month
  • May be required to perform additional duties as needed

Qualifications/ Requirements:
  • BS/BA degree in a scientific or health-rated field.
  • Professional work experience in Quality environment with hands-on experience related to clinical trials.
  • Manager Level;   Minimum  6 years of progressive experience quality assurance in the   pharmaceutical and/or biotechnology industry
  • Sr. Manager Level:  Minimum 8 years of progressive experience quality assurance in the  pharmaceutical and/or biotechnology industry
  • Knowledge of applicable FDA, EU and ICH regulatory requirements for GCP and GLP.
  • Experience working with clinical trial pharmaceutical regulations and guidance
  • Experience with internal and external audits of clinical studies, vendors, data and reports is strongly preferred but not required (training provided)
  • Understanding of regulatory inspection processes is strongly preferred but not required (training provided)
  • Understands Clinical SOPs, department controlled documents, Trial Master File, GCPs and regulations
  • Knowledge of drug development, study design, data and trials management, procedures and documentation practices
  • Flexible and able to work in a fast paced environment while handling multiple demands with shifting priorities
  • Demonstrates effective interpersonal skills and independent problem solving capabilities
  • Coordinates projects to successfully meet timelines
  • Possesses strong analytical skills and attention to detail
  • Excellent communication skills, able to present complex information clearly and logically
  • Proficient in word processing, spreadsheets and database software applications on a PC, specifically MS Office: Word, Excel and PowerPoint

Denise Kowalski
Clinical Recruiter

Denise is a focused, relationship-driven individual who brings creative energy and an eagerness to conquer new challenges to her role. A passionate life-long learner, Denise’s excellent communication skills, strong work ethic, and genuine interest in helping others make her a valuable asset to the Clinical team.

Apply Online

Not ready to apply?

Send an email reminder to:

Share This Job:

Related Jobs: