Quality Assurance Vendor Quality Manager in Summit, NJ at Apex Life Sciences

Date Posted: 5/13/2018

Job Snapshot

Job Description


Please note, this position is a 6 month contract with the possibility for extension.

  • This position provides quality oversight for contract or internal manufacturing organizations used to manufacture drug substance (API) and/or drug products in accordance with policies, standards, procedures and international cGMP’s.
  • The incumbent will oversee multiple products at various Contract Service Providers (CSPs), such as CMOs.

RESPONSIBILITIES: 

  • Partner with Technical Operations to identify and qualify Contract Service Providers (CSP). 
  • Serves as the Quality Ops single point of contact and is responsible and accountable for the quality and compliance performance of the assigned CSP(s). 
  • Oversee the Vendor Quality Management System to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specification and improvement projects are managed in a compliant and timely manner. 
  • Responsible for the content of the Quality Agreement and ensures compliance. 
  • Partners with Technical Operations to assess overall product quality performance, including identifying any product-specific quality and compliance risks and develops a mitigation plans based on a risk based approach. 
  • Final Quality Operations approver of all Vendor GMP documents that require Quality approval such as Investigations, Deviations, Change Controls, Validation documents, Specification, etc. (under the supervision of Dev QA management) 
  • Develops, collects and/or monitors Quality metrics, assesses the results in collaboration with Technical Operations, develops corrective actions with the vendor Quality unit and reports results to management. 

EDUCATION AND EXPERIENCE: 

  • BS degree preferred, Associates degree will be considered; advanced degree preferred. 
  • 7-10 years of QA experience within the pharmaceutical industry
  • Must have expert cGMP and Quality knowledge. 
  • Ability to author, review and approve technical documents. 
  • Ability to author, review and approve investigations, quality technical agreements, and risk assessments. Ability to critically interpret results and determine the desirability of new or additional content for GMP policies and standards, etc. 
  • Working knowledge of international GMP requirements/expectations and industry standards. 
  • Possibility of 5% travel

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.