Associate Director, Quality Assurance 2305-5829

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.