Associate Director, Quality Assurance 2305-5829

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Company Overview

This is a clinical-stage biotechnology company that places special emphasis on high-mortality cancers.

Territory: New Jersey/New York
Therapeutic Area: Oncology

This position will play a key role in the quality management of external partners. It is an independent role and the Associate Director will set a unique path within the organization.

Self-motivated and operates effectively within an entrepreneurial fast-paced team environment.

Essential Duties and Responsibilities

  • Development and maintenance of GXP quality systems and procedures that ensure compliance with established standards and agency guidelines (FDA, MHRA EU, ICH).
  • Represent Quality both internally (e.g., clinical operations, regulatory, CMC, non-clinical) and externally (e.g., CRO’s, Vendors, Investigator Sites).
  • Manage and maintain the vendor qualification process (GLP, GCP, GMP) including audits.
  • Initiate new, revise existing, and conduct training of SOPs.
  • Ensure documents are reviewed for completeness, accuracy, and conformance to GXP procedures and internal SOPs.
  • Perform QA review of cGMP-related documentation, such as specifications; test methods; validation and technical protocols and reports; stability protocols and reports; master and executed production records; deviation, investigation, and out-of-specification reports.
  • Perform Quality investigations of events or deviations.
  • Support development and maintenance of Quality Agreements with suppliers/partners.
  • Manage quality systems such as document control, training, CAPA, and change control.
  • Participate in cross-functional teams in support of new drug product development.
  • Perform ad-hoc special projects as necessary.

Qualifications (Education & Experience)

  • Bachelor’s Degree or higher in biology, chemistry, or related life-sciences discipline; master’s degree preferred.
  • Minimum 8 years of experience in quality assurance or related fields within the pharmaceutical or biotech industry.
  • At least 5 years of direct experience in GXP.
  • Thorough knowledge of global rules, regulations, and guidances governing the quality and safety of drugs and biologics in all phases of clinical development.
  • Strong attention to detail with the ability to analyze, interpret, and solve complex problems.
  • Strong time-management and organizational skills with the ability to be flexible to meet set goals and timelines.
  • Strong knowledge of standard software, including MS Office Word, Excel, and PowerPoint.
  • Full COVID-19 vaccination is required.

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Associate Director, Quality Assurance 2305-5829
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