Sr. Manager/Associate Director, Clinical Quality
The Judge Group Inc.

Atlanta, Georgia

Posted in IT


This job has expired.

Job Info


Location: REMOTE
Description: Our client is currently seeking a Sr. Manager/Associate Director, Clinical Quality Assurance .

Key Responsibilities:

  • Manage/provide oversight or conduct GCP/GLP/PV (internal, vendor and clinical sites) on site as well as remote audits
  • Identify the need for conduct of various audits (including clinical sites, central IRBs, vendors and PV partners, etc.)
  • Manage contract auditors in the scheduling process, kick-off meetings with contract auditors and internal functional groups, assist in the drafting of audit agendas, confirmation letters etc. as needed
  • Oversee the audit response process for the various audits, regulatory inspections and ensure acceptability of actions to address findings through the CAPA process as applicable
  • Work closely with different functional groups to ensure/coordinate appropriate resolution of audit findings, non-compliance issues, investigations, etc. in a timely manner, including review and approval of CAPA plans, as applicable
  • Work directly with CROs and other external contractors and collaborators, managing the chain of communication related to GCP compliance
  • Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management
  • Draft, and revise company SOPs to assess their adequacy and compliance with industry and regulatory requirements
  • Attend cross-functional team meetings, provide guidance to different functional groups (including clinical and PV), based on interpretation of current regulations to ensure best practices including risk-based approach
  • Assist in preparation and support of regulatory GCP/GPV inspections, prepare, and conduct Pre-Approval Inspection (PAI) activities as needed
  • Escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management via the Quality Board
  • Provide QA review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, Investigator Brochures and other relevant documents
  • Provide and/or assist in periodic GCP training to the internal and external company staff as necessary
  • Assist in preparing and managing departmental budget.
Qualifications
  • At least 8-10 years of direct GCP pharmaceutical/biotechnology experience
  • Solid understanding and application of GCP, GLP and ICH E6R2 requirements. Good working knowledge of GPV guidelines
  • Ideal candidate will have broad experience in product development, support of clinical operations, field GCP auditing and regulatory inspection support.
  • A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
  • Excellent interpersonal and conflict management skills to assure effective interactions within and across departments
  • The ability to simultaneously handle multiple project issues while dealing with time demands, ability to provide a solution-based approach to emerging challenges
  • A strong team player is required with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations & business needs
  • Proven track-record of leadership & building relationships with both internal & external customers
Contact: arawat@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com


This job has expired.

More IT jobs


AF Group
Lansing, Michigan
Posted about 3 hours ago

Emergent Holdings
Southfield, Michigan
Posted about 3 hours ago

Emergent Holdings
Southfield, Michigan
Posted about 2 hours ago

Improve Job Search

Subscribe to job alerts and add your resume to our resume database for employers!


Sign up now