Associate Director, GCP Quality Assurance in Cambridge, MA at APEX Systems

Date Posted: 12/4/2019

Job Snapshot

Job Description

Job #:  1013761
Associate Director, Clinical Quality Assurance 1013761
Job Scope & Purpose: 
Our Cambridge based client is seeking a permanent addition to its Quality Assurance team to lead the development and implementation of Quality Assurance systems and inspection readiness. The ideal individual will manage internal and external audit programs, risk-based auditing planning, and will either conduct or plan and prepare audits for GCP, as well as oversee audit plans for GLP/GVP. The successful candidate will also efficiently collaborate cross-functionally with various members of the clinical development team to ensure the implementation of best practices.
Primary Job Responsibilities
  • Develop and oversee internal processes and systems for GCP activities
  • Direct and manage the GCP audit program, prepare audit schedule and establish the audit strategy for investigational drug clinical research programs
  • Oversee and confirm the proper recording and reporting of audits, and ensure appropriate corrective/preventive actions have been requested and documented effectively
  • Participate in risk assessment of all new and current vendors/CRO partners, and conduct or coordinate vendor qualification audits/assessments
  • Manage the company's internal vendor qualification and reassessment
  • Lead GCP inspection readiness initiatives and activities
  • Lead training of GCP procedures and quality systems
  • Ensure appropriate Standard Operations Procedures are written in accordance with regulatory requirements and global industry standards
  • Identify compliance issues and determine the approach to complex compliance issues, as well as reporting findings to management with recommendations for resolution
  • Verify appropriate CAPAs have been implemented and documented
  • Develop and managing reporting of Clinical Quality metrics to senior leadership

Primary Job Requirements:
  • Bachelor of Science degree required, Master’s degree preferred with a minimum of seven years experience in pharma/biotech industry
  • Extensive GCP experience is required, and broad GLP/GVP experience is strongly preferred 
  • Previous experience preparing for and leading Health authority inspections required
  • Strong knowledge of GCP and ICH guidelines
  • Extensive experience in technical concepts required for GCP audits
  • Previous experience in developing and overseeing Quality Management Systems
  • Up to 25% travel may be required (travel may be domestic and international)

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
 
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
tjamison@stratacuity.com
Code: TechOps
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.