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Manager, Quality Assurance - United States  

Company managed [?] Still accepting applications

Posted on : 24 May 2017

Project Description

Description:    
  • Our company is a branded pharmaceutical company that entered the dermatology market in  2008. 
  • Our company is a wholly owned  subsidiary of our's Laboratories, one of India's largest and most  respected pharmaceutical companies. 
  • Our company is a fresh face in the  dermatology community and will provide innovative products and solutions that  meet unmet physician and patient needs.
  • We also differentiate our company in  our reliance on research and development, in our commitment to using input from  physicians to shape our focus and future direction, and in our support of the  dermatology community.
  • The Quality  Assurance Manager is responsible for providing leadership and Quality Assurance  Management support within Proprietary Products division.
  •  This individual will have responsibility for Quality aspects related to  Quality Systems, oversee and manage contract manufacturers, Finished Product  Batch Release and Change Control.



Responsibilities:·          
  • Oversee  CMO’s to ensure products manufactured for our company are produced in accordance  with regulatory requirements, NDA commitments and company requirements ·          
  • Conduct batch record review and  release, change control review and approval, process and analytical  investigations, product complaints, Annual Product Reviews, CAPA follow up etc.  related to products manufactured at CMOs in compliance with company requirements.·          
  • Coordinate and perform for-cause, due  diligence and general GMP audits of contract manufacturers, packagers,  laboratories and other suppliers.·         
  •  Write and Implement  SOPs in the Propreitory products division consistent with company's ’s  global systems regarding CMO’s.·          
  • Prepare and Review Quality Agreements,  ensure Quality Agreements are implemented where required, and ensure compliance  with the requirements of the Quality Agreements.·          
  • Participate in Quality review meetings  with CMOs, track Quality metrics, identify risk areas and propose CAPAs to  resolve Quality matters with external partners·          Prepare and discuss quality issues  with management on a monthly basis·         
  •  Participate in FDA Inspections and customer audits as required
  • B.S. or M.S. in a Chemistry, Biology,  or other life science, with 8+ years of progressive experience in a  pharmaceutical and/or biotech Quality manufacturing environment.· 
  • Strong understanding of pharmaceutical  manufacturing, packaging and testing processes, and management of Quality  Management Systems.·          
  • Thorough understanding and familiarity  with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA  guidance documents·          
  • Must have prior experience in working with CMOs.·          
  • Excellent communication (verbal and  written), strong analytical and investigative, organizational and time  management skills; strong attention to detail. ·         
  •  Excellent negotiation and influencing  skills required. ·          
  • Travel (10-30%) between CMO and  Corporate location in NJ.





Equal Opportunity Employer: 

Minorities/Women/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive  consideration for employment without regard to race, color, religion, sex,  sexual orientation, gender identity, national origin, or protected veteran status  and will not be discriminated against on the basis of disability.