Senior Manager/Manager, Quality Assurance, CMC:

Growing and Flexible Biopharma, Central/North NJ

Summary: Our Client, an exciting Biopharmaceutical company, is looking for an experienced Quality Assurance professional looking to take the next step in their career.  In this newly created role, you will report directly to the Sr. Director of Quality Assurance and be responsible for all CMC/GMP related activities, including: developing a CMC-related QA plan, batch auditing, external auditing, interfacing with the FDA, 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: Edison, NJ Area

Compensation: Compensation will be competitive and will include a bonus.  Benefits consist of a 401k match, vacation days, 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.  You will have the opportunity to work with new technologies in multiple therapeutic areas.  You will be reporting to the Sr. Director of Quality Assurance.
• Growing Company: They will be filing multiple NDAs in the near future.  Their pipeline includes compounds in pre-clinical, Phase I, II and III.
• Unique Environment: Our client encourages creative thinking and teamwork as they prepare to launch their first of many products.
• Great Location: Easily commutable from both Northern and Central NJ via route 287, 80, 78, and 24.

Responsibilities:

• Establishing and maintaining a CMC-related quality assurance plan
• Producing change control documents and maintaining files
• Conducting internal/external audits to assure GMP compliance
• Reviewing manufacturing, packaging, and analytical contractor documents

Requirements:

• 3-7 years of CMC/GMP, Quality Assurance experience
• BS degree
• Experience with FDA regulations
• Excellent written and verbal communication

Cornerstone’s Privacy Policy

Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information.  Any information provided/shared with us will not to be shared with any parties outside of Cornerstone Search Group without your prior permission.

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.