Skip to main content

This job has expired

You will need to login before you can apply for a job.

GCP Quality Assurance Manager/Sr Manager/ Biotech/Pharmaceutical

Employer
Grimaldi Recruitment Services
Location
94041, Mountain View
Start date
Apr 25, 2019

View more

Discipline
Science/R&D, Biomedical Sciences
Required Education
Bachelors Degree
Position Type
Full time

SUMMARY 

The Manager of GCP Quality Assurance is responsible for implementing and maintaining a balanced, proactive, and phase appropriate approach to GCP Quality Assurance. This position will play an essential role in the company's Clinical Quality Assurance (CQA) group focused on Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) compliance. The incumbent will perform internal and external GCP, GLP, or GVP audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH guidelines, procedures and protocols. Responsibilities will also include providing guidance to clinical and nonclinical study teams, training of staff, and development/maintenance of GCP/GLP or GVP related quality systems. 

RESPONSIBILITIES 

  • Perform quality assurance (QA) activities related to FDA and ROW regulations across therapeutic areas and provide GCP guidance for all phases of drug development 
  • Develop/improve and manage quality systems and processes to include: o Creation/revision of appropriate SOPs 
  • Maintaining key QA systems, such as; investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits, developing and managing integrated Quality Management Risk plans. 
  • Supporting the activities related to the vendor management process training, SOPs, etc. 
  • Conducting/managing routine and for cause audit of investigator site, vendors, internal audits, etc. 
  • Conducting/managing review of key documents such as study protocols, informed consent documents, Investigator brochures, Clinical study reports, submission modules, etc. 
  • Performing the review of trends and reporting significant investigation/deviation issues and system deficiencies to senior management, as appropriate 
  • Lead and manage GCP Quality investigations 
  • Participate and represent Clinical Quality in meetings and discussions as needed 
  • Perform inspection readiness activities and participate in managing regulatory health authority inspections. 
  • Promote continuous improvement Expert knowledge of GCP, particularly FDA and ICH requirements 
  • Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors 
  • Reports significant quality deficiencies to CQA management 
  • Attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment. 
  • Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance 
  • Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations 
  • Other duties as assigned 
  • Reports to Associate Director, Quality Assurance 

RESPONSIBILITIES 

  • Minimum BS/BA degree in biological sciences, chemistry, or related field 
  • 4-8 years of progressive pharmaceutical experience in a clinical/nonclinical development arena 
  • Minimum of 5 years in GCP/GLP or GVP auditing inclusive of developing quality systems 
  • Minimum of 1-year exposure of regulatory authority inspections and inspection readiness preferred 
  • PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) 
  • Must be a team player 
  • Excellent working knowledge of GCP/GLP or GVP -related regulatory requirements and ICH guidelines 
  • Broad experience in the pharmaceutical industry with a strong clinical development understanding 
  • Detail-oriented with analytical and problem-solving skills 
  • Ability to work effectively in a fast-paced environment with initiative and great organization skills 
  • Ability to deal with ambiguity, creative and pragmatic approach to problem solving. 
  • Excellent verbal and written communication and interpersonal skills 
  • Computer system validation (CSV) knowledge is a plus 
  • Proficient with computers and typical office software (e.g., Microsoft Office products) 

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert