Lexicon Pharmaceuticals is currently recruiting for an agile, results focused Director, GCP Quality Assurance to join our team in Basking Ridge, New Jersey.
Job Summary: The Director, GCP Quality Assurance will report to the Vice President, Regulatory, Quality and Safety Operations and will focus on GCP compliance within Lexicon sponsored clinical trials and the R & D organization. This position will support quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment.
Key Responsibilities include, but will not be limited to:
Ensuring ongoing compliance with all applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes and products.
Representing the GCP function on various clinical project teams and other working groups, functional areas, and with external partners providing GCP consult and supporting R&D clinical development programs.
Partnering with Lexicon R&D staff to develop plans for quality oversight of GCP activities for clinical trials, ensuring compliance with global quality systems across Lexicon locations with focus on GCP.
Supporting inspection readiness/management activities and regulatory authority inspections.
Overseeing conduct of and participating in the conduct of internal and external audits to assess compliance with GCP requirements, investigational plans and Lexicon standards for clinical trial related activities.
Serving as a senior advisor to the VP of Regulatory and Quality, and to the Executive Management Team regarding GxP quality practices and issues.
Bachelor’s Degree is required, Master’s degree is a plus
Certification in GCP Quality Auditing required
Minimum of 12 years of work experience in the pharmaceutical industry and at least 8 years performing Clinical Quality Assurance functions (GCP) for clinical trials phases I-IV including the auditing of clinical investigators and CROs/vendors.
In depth knowledge of GxP quality systems, quality assurance, quality control, and GCP audits.
Hands -on experience in regulatory inspections, vendor audits, vendor qualification, and internal audits is required.
Experience supporting IT systems audits and understanding of GMP and GLP quality standards and practice is highly desired.
High level of written and oral communication skills and presentation skills.
Use of Microsoft Office (Excel, Word, Microsoft Project, PowerPoint).
For additional information about Lexicon and its programs, please visit www.lexpharma.com.
An Equal Opportunity Employer - Females, Minorities, Veterans, and Disabled.
Lexicon Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test, background check and verification of credentials before beginning employment.
Internal Number: 570-252
About Lexicon Pharmaceuticals
Lexicon Pharmaceuticals is a research and development biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for people with serious, chronic conditions which will effectively treat disease and improve patient lives.
Our world class research and development offices Basking Ridge, New Jersey and The Woodlands, Texas. Lexicon employees are inspired by the idea that their work can improve patients' lives and we know that our employees are important to the success of our mission. We are dedicated to making Lexicon a great place to work by providing employees with the benefits, services, and programs which will allow them to reach their full potential.