Director, External Quality OperationsUnited States - California - Santa MonicaQualityRegular
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.
We are seeking a highly motivated leader to join us as a Director External Quality Operations within Kite’s Quality Organization. The Director will report to the Executive Director of Product & Distribution Quality. The Director will play a pivotal role within our technical operations organization with accountability to assure quality amongst Kite’s external partnerships. Scope includes contracted service providers such as development and manufacturing organizations (CMO/CDMO), contract testing labs (CTLs) and Quality support for Strategic Partnerships spanning clinical and commercial operations within the cell therapy space.
The Director External Quality Operations will have opportunities to work and share knowledge with leaders and partners across Kite’s Global Technical Operations organization (e.g. Process Development and MSAT, Regulatory, Quality, Manufacturing, and Supply Chain), as well as international partners, multiple CMO/CDMO and CTL. The ideal candidate will have strong leadership skills (career development and mentor); technical skills (biologics/gene and cell therapy manufacturing and testing operations, international GMP regulations, and drug development life cycle); strategic, and network-based thinking (tact, quality agreement/contract negotiation, project management).
This position will be based at Kite’s corporate headquarters in Santa Monica, CA.
Responsibilities of the Director of External Quality Operations include:
- Leading the External Quality Operations team that includes the QA functional leads for CMO/CDMO, CTL and Strategic Partnerships and ensuring effective cross-functional coordination and execution of quality capabilities.
- Providing recommendations for the best-suited partner (excluding Strategic Partnerships) to meet Kite's strategic objectives and quality risk profile. Consulting on supply and quality agreements, onboarding and tech transfer plans for each partner.
- Quality representative on joint steering committees with Executive leaders across contracted services providers and partnerships, as determined.
- Ensuring team advance progress on key projects/initiatives; manage critical issues or risks that emerge and implement solutions; meet production demand/testing timelines; and monitor KPIs related to performance of Kite's contracted services providers and strategic partners
- Providing leadership and direction for CMO/CDMO and CTL related issues and execution of quality systems - SCARs, CAPAs, OOS, product disposition, deviations and change records and ensuring each partner is receiving adequate Quality support & resources/ accountable for meeting "service level agreements"
- Identifying quality requirements on risk mitigation strategies, compliance/ technical issue resolution, and plans for continuous improvement / OE programs
- Resolving issues and escalating as appropriate
- Up to 40% travel (both domestic and international)
- Lead, develop, mentor and manage staff
- Advanced scientific degree (i.e. MD, PharmD, PhD) and 8+ years’ experience in working within the biotechnology and/or pharmaceutical industries in a Quality management role OR
- Master’s Degree and 10+ years’ experience in working within the biotechnology and/or pharmaceutical industries in a Quality management role OR
- Bachelor’s Degree and 12+ years’ experience in working within the biotechnology and/or pharmaceutical industries in a Quality management role OR
- High School Degree and 16+ years’ experience in working within the biotechnology and/or pharmaceutical industries in a Quality management role
- Experience in a Quality CMO management role
- A quality operations leader, skilled at partnering and collaborating with external quality leaders and teams, specifically with contract development and manufacturing organizations (CMO/CDMO), and Contract Testing Labs (CTLs), and strategic business partnerships
- Diplomacy skills and ability to supervise performance and proactively identify and mitigate risks
- Experience in managing & collaborating in a cross-functional working model with support from fully- and partially dedicated resources
- Knowledge & experience in working across various GXP settings
- Exhibit leadership skills and strategic, network-based thinking
- Experience with direct FDA interaction (or other regulatory agencies) required
- Experience auditing CMOs/CTLs. Experience with direct FDA interaction (or other regulatory agencies) required
- Experience writing, evaluating and closing investigations, CAPAs and change control records.
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- International partnership experience (e.g. CDMO, CTL and/or Strategic Partners)
- Cultural sensitivity and understanding of regional & global perspectives / marketplace
- Strong data analytics skills e.g. Tableau, Excel
- Strong skills in Risk Assessments, FMEA and QbD
- Budget and Financial Planning experience
- Excellent decision-making skills in a meaningful environment
- Excellent oral and written communication skills
- Strong interpersonal and people development skills, open minded to the diverse opinions of others and able to lead effectively through influence
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Does this sound like you? If so, apply today!