Senior Specialist, Product Complaints
Quality | Santa Monica, CA | Full Time
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term, durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. For more information on Kite, please visit www.kitepharma.com.
If you are a highly motivated, independent, and organized individual with a strong quality mindset, we currently have a great opportunity for a Product Complaints Specialist (QA). The Product Complaints Specialist will be responsible for the management and handling of commercial drug product complaints from receipt to closure. The ideal candidate is motivated to achieve an increasing knowledge of Kite’s product and unique supply chain, and work towards increasing quality and efficiencies within the product complaints process and beyond. The ideal candidate will have excellent temperament and skills to work in collaboration with key stakeholders, external partners, healthcare providers and patients.
The principal responsibilties of the position include, but not limited to, the following:
- Serve as point of contact for commercial drug product complaints.
- Receive, process, and initiate product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure.
- Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
- Assess product complaints for potential regulatory notification (BPDR, EMA Defective Product Notification, etc.) and submit regulatory notifications if required.
- Interface and collaborate with various departments (Manufacturing, Quality Assurance, Product Sciences, Safety/Pharmacovigilance, etc.) and vendors/contractors on product complaint issues.
- Conduct follow-up with reporters for additional information necessary to complete a detailed investigation.
- Arrange the return of complaint materials to appropriate departments for evaluation.
- Assure that all product complaints are investigated to the appropriate level within the required timeline.
- Critically review and approve all investigation conclusions.
- Provide response to product complaint reporters.
- Alert Quality Management of all potential regulatory notification, and escalate trends and product complaints that potentially require a regulatory action (e.g. recall, production hold, etc.).
- Perform analysis and trending of product complaints. Generate monthly product complaint reports to identify and evaluate any trend signals observed and initate investigations when required.
- Represent Kite as the Subject Matter Expert (SME) for the product compalints process.
- Interact with auditors and regulatory bodies to present the product complaint system during audits and inspections.
- Educate employees and contractors on the reporting of product complaints.
- Support the Annual Product Review process.
- Perform other duties as assigned.
- Bachelor's degree with a minimum of 5 years of experience in Quality Assurance or a GMP related field within biotechnology, biologics, or pharmaceutical manufacturing facility.
- Working knowledge of cGMPs and other regulatory requirements governing drugs and biologics.
- Knowledge of US/EU cGMP requirements pertaining to drug product complaints reporting and investigation.
- Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
- Good understanding of the manufacture of biological drug products and the linkage to customer complaints.
- Strong attention to detail, good organizational skills and well-structured.
- Has a systematic way of working, prioritizing tasks based on risk or criticality - seeking effective solutions within the complexity that surrounds product complaints.
- Excellent troubleshooting and problem-solving skills.
- Skill in writing investigation summaries and complaint responses.
- Independent, organized and able to schedule work without supervision to meet schedule deadlines.
- Ability ot work independently as well be an effective team member.
- Approachable and possess the ability to forge solid working relationships with colleagues across Kite, its partners and contractors.
Kite Pharma, is headquartered in Santa Monica, CA. To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.