Director/Associate Director, QA/GCP Compliance: Growing and Flexible Biopharma, North/Central NJ: Cornerstone Search Group, LLC

Director/Associate Director, QA/GCP Compliance:

Growing and Flexible Biopharma, North/Central NJ

Summary: Our Client, an exciting Biopharmaceutical company, is looking for an experienced GCP professional looking to take the next step in their career. In this newly created role, you will report directly to the VP and be entirely responsible for all GCP related activities, including: site audit process, internal audit, Investigator Meeting representative, etc. Benefits, vacation time, compensation, and work environment are all very attractive. Easily commutable from both Northern and Central NJ via route 287, 80, 78, and 24.

Location: Bridgewater, NJ

Compensation: Compensation will be competitive and will include a double-digit bonus. Benefits consist of a generous 401k match, 5 weeks vacation, exceptional health coverage, short/long-term disability, etc.

Attractive features about this position and company:

• Attractive Opportunity: This is a newly created position, which offers a great deal of responsibility and autonomy. Furthermore, as the company continues to grow, you will have the opportunity to grow the group in your liking.
• Growing Company: They are in the process of filing multiple NDAs in the near future. Their pipeline includes compounds across Phases I, II, and III.
• Unique Environment: Our client offers a family-friendly atmosphere, including a flexible work schedule. The culture is very collegial in nature.
• Great Location: Easily commutable from both Northern and Central NJ via route 287, 80, 78, and 24.

Responsibilities:

• Establishing a GCP audit plan and ensuring processes are adhered to
• Creating corrective action plans on audit results for Senior Management
• Running internal audits and preparing the clinical team for federal inspections
• Training clinical team on all GCP/QA related activities
• Conducting domestic and global site audits
• Developing a close relationship with multiple functional areas to support SOPs

Requirements:

• 3-7 years of GCP/QA experience with at least 3 years of auditing experience
• BS degree
• Expertise in FDA regulations, ICH documents, and all GCP/QA areas
• Excellent written and verbal communication

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Contact:

Jay Paciello

Recruiter, Specialized Pharmaceutical Practice

jpaciello@cornerstonesg.com

Cornerstone Search Group, LLC

6 Campus Drive

Parsippany, NJ 07054

P 973-656-0220 x736

F 973-656-0228

Web/URL: www.cornerstonesg.com

About Cornerstone Search Group, LLC

Cornerstone Search Group is a specialized Pharmaceutical | Biotechnology Executive Search & Recruitment firm located in heart of New Jersey's Pharmaceutical corridor. Cornerstone Search Group helps its Pharmaceutical | Biotechnology clients identify, attract and hire accomplished professionals from the experienced Staff Levels through the Senior Leadership ranks who are involved with the discovery, development and commercialization of drugs/therapeutic treatments for the US and international markets.

Cornerstone Search Group's team of highly experienced Pharmaceutical | Biotechnology Specialty Consultants/Recruiters are adept at using their industry knowledge and contacts to generate desired results for their clients and candidates.

Building better companies. Building better careers.®

Other Opportunities

Cornerstone Search Group is currently working on Executive Search & Recruitment assignments in several of the following business areas: Discovery, Clinical Research & Development, Medical Affairs and Commercial/Marketing, and in several of the following functional areas: Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Data Management, Health Economics & Outcomes Research, Market Research, Medical Affairs, Medical Directors, Clinical Scientists, Medical/Drug Information, Medical/Scientific Communications, Medical Writing, Pricing & Reimbursement, Product/Brand Management, QA/QC, Pharmacovigilance & Drug Safety, Regulatory Affairs, Scientists, Sourcing and Pathologist. Please visit our company’s web site for a comprehensive listing of available positions/opportunities at www.cornerstonesg.com.