LFB USA - Director Clinical QA

US-MA-Southborough
Job ID
2017-1298
# of Openings
1
Category
Quality Assurance/Quality Control
Type
Full Time
Company
LFB USA

Overview

The primary responsibility of this position is the management and continuous improvement of the GCP Quality System, leading and management of GCP audits to assure that all aspects of clinical trials conducted have been executed in compliance with applicable FDA, ICH GCP Guidelines and other government and/or country specific regulations. Primary duties include but are not limited to liaises with colleagues at parent company in France, various internal departments and external groups including Contract Research Organizations (CROs), investigator sites ensuring a high level of quality and consistency across the programs and studies, development of the master audit plan as a means to ensure compliance with appropriate policies and procedures and contributions to due diligence activities as appropriate. This position will serve in an advisory/consultative role in compliance related manners, assist clinical program teams in implementing corrective and preventive actions and enable program teams to be inspection ready and support a culture of sustainable compliance. Under the direction of the Head of Quality Assurance, this position is responsible for providing strategic direction and compliance oversight to the clinical programs being managed by the LFB-USA Clinical Development organization.

Responsibilities

  • Review SOPs to assess consistency and compliance with regulatory requirements/internal standards and determine/ensure effective implementation across the organization. Participate in the review of drug safety practices for clinical trial compliance.
  • Organize, lead, participate in audits (investigator sites, trial master files, database, study reports) and internal audits (systems, processes, vendors, computer system validation) across clinical operations (including preparation of audit plans, checklists, reports and certificates).
  • Participate in the review of clinical protocols/clinical source data to ensure compliant execution of clinical studies.
  • Participate in the review of clinical study reports.
  • Manage/review issues and occurrences from clinical studies to ensure cGCP compliance, including evaluation of CAPAs.
  • Assist with providing training to QA and Clinical staff as necessary for GCP.
  • Ensure the appropriate corrective and preventive actions are completed in a timely manner. Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. As appropriate escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management. Audit includes but is not limited to investigator sites, central IRBs, CROs.
  • Perform program specific root cause analysis of compliance issues and provides the appropriate metrics for tracking, trending for the overall QA reporting requirements to functional and senior management.
  • Develop an overarching strategy related to proactive and sustainable compliance for the assigned programs.

Qualifications

Bachelor’s degree in a life science required; Master’s Degree in management or scientific discipline preferred. At least 10 years of pharmaceutical/biotechnology experience. Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance and GCP auditing.

 

Competencies:

 

  • Must have a working knowledge of US, International Conference on Harmonization (ICH) and EU GCP, regulations and guidelines
  • Excellent interpersonal, oral and written communication skills
  • ASQ, Auditor, Clinical Trial Associate or Clinical Trial Manager accreditation highly desirable
  • Detail oriented, good organization and problem solving skills
  • Self-motivated with strong leadership abilities
  • Must be results-oriented, multi-tasking, quick learner, able to respond to the urgent needs of the team and show strong track record of meeting deadlines.
  • Good computer skills and inclination to adopt technology to maximize efficiency.
  • 15% travel is required (domestic/international).

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed