Job description – Assoc Director, QA Technical Services

The Associate Director, QA Technical Services (External Quality) will be responsible for developing, implementing and facilitating transfer of customer related processes into the Cognate BioServices organization development programs. This role will also be responsible for the development and execution of leadership, soft skills, as well as, partnering with client Corporate Management in executing the Cognate customer onboarding process.

 

JOB RESPONSIBILITIES:

  • Evaluate the Quality needs of incoming clients by assessing the prospective clients Quality Systems, while developing a plan with key milestones to integrate their process into the Cognate Quality Systems.
  • Build solid cross-functional relationships with relevant external departments necessary to ensure a smooth transition into Cognate’s Quality System.
  • Will support the development of the Technology Transfer process from the client to all Cognate facilities, as well as, the transfer process between all Cognate facilities.
  • Maintain knowledge base on policies and procedures concerning Cognate’s Quality Systems and operational philosophies.
  • Facilitates customer inspections and responses in coordination with the Cognate Site Leadership Team.
  • Other duties, tasks or projects as assigned.

 

QUALIFICATIONS:

  • Demonstrated knowledge of current regulatory interpretations of QMS requirements and current industry best practices.
  • Ability to multi-task effectively.
  • Proficient in computer system use, including but not limited to Microsoft Office Suite and QMS software.
  • Strong analytical, problem-solving, and project management skills.
  • Good leadership/interpersonal/communication/influencing/negotiation skills.
  • Certification by American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) preferred.

 

EDUCATION AND EXPERIENCE:

  • BS degree in science or engineering.
  • 7 years of experience in Quality, Manufacturing, Engineering or related field.
  • 5 years of experience hosting and leading customer inspections.

 

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