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.
To apply for this job please visit go.trinetpharma.com.
Associate Director, Quality Assurance 2305-5829