Director of Raw Materials Quality - Site Based, Redmond, WA

Cyprotex • Redmond, WA

1d • Onsite

About The Position

We’re looking for a passionate and curious Director, Raw Materials Quality to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a Director, Raw Materials Quality at Just Evotec Biologic, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team. The Director, Raw Materials Quality provides leadership and oversight for the raw material lifecycle quality program supporting GMP manufacturing of biologics. This role is responsible for ensuring that raw materials used in manufacturing meet all applicable regulatory, quality, and internal requirements through effective oversight of raw material testing, material disposition, and supplier quality management. The Director leads teams responsible for incoming raw material testing, supplier qualification and monitoring, and QA disposition activities. This role partners cross-functionally with Manufacturing, Supply Chain, Quality Assurance, and Regulatory to ensure reliable and compliant raw material supply for clinical and commercial programs.

Requirements

• 8+ years of experience in Quality, QC, or Supplier Quality in a GMP-regulated pharmaceutical or biotechnology environment.
• 5+ years of leadership experience managing technical or quality teams.
• Experience supporting biologics manufacturing across clinical and/or commercial stages.
• Experience with raw material testing, supplier quality, and material disposition processes.
• Strong knowledge of cGMP regulations and regulatory expectations (FDA, EMA, ICH).
• Understanding of raw material control strategies in biologics manufacturing.
• Familiarity with analytical testing methods for raw materials.
• Experience with quality and laboratory systems (eQMS, LIMS, ERP).
• Knowledge of supplier qualification and auditing practices.
• Strong leadership and team management skills.
• Effective cross-functional collaboration.
• Solid problem-solving and decision-making abilities.
• Ability to manage competing priorities in a GMP environment.
• Strong communication and organizational skills.
• Attention to detail and commitment to quality.

Responsibilities

• Lead the Raw Materials Quality function, including: QC Raw Materials Testing Raw Material Lot Disposition Supplier Quality Management
• Manage and develop managers and team leads responsible for day-to-day operations.
• Ensure effective execution of raw material quality activities in support of manufacturing timelines.
• Establish and monitor functional goals, KPIs, and performance metrics.
• Promote a culture of quality, accountability, and continuous improvement.
• Escalate quality, compliance, and supply risks to senior leadership as appropriate.
• Implement and maintain robust processes for: Raw material qualification Supplier qualification and monitoring Incoming material sampling and testing Raw material lot disposition
• Ensure risk-based approaches to raw material control are applied in alignment with regulatory expectations.
• Support development and lifecycle management of raw material specifications and control strategies.
• Drive continuous improvement in raw material quality, reliability, and testing turnaround times.
• Provide oversight of QC raw material testing activities to ensure compliance with GMP requirements.
• Ensure materials are sampled, tested, and reviewed according to approved procedures and timelines.
• Oversee analytical testing programs (e.g., compendial and instrumental methods such as FTIR, HPLC, pH, etc.).
• Ensure analytical methods are qualified or verified as required.
• Ensure timely resolution of QC investigations (e.g., OOS, deviations, atypical results).
• Oversee external laboratory testing where applicable.
• Oversee QA disposition of raw materials to ensure compliance with cGMP requirements.
• Ensure timely release of materials to support manufacturing operations.
• Ensure appropriate review of: Certificates of Analysis Supplier documentation Analytical testing results Qualification status
• Ensure disposition decisions are properly documented within quality systems.
• Lead Supplier Quality activities across the supplier lifecycle, including qualification, monitoring, and requalification.
• Ensure supplier quality systems comply with internal standards and regulatory expectations.
• Oversee supplier audits and ensure timely closure of observations.
• Ensure effective management of supplier-related quality events (deviations, complaints, CAPAs, change controls).
• Monitor supplier performance metrics and drive improvements as needed.
• Ensure all activities comply with global regulatory requirements (FDA, EMA, ICH) and internal quality systems.
• Ensure adherence to processes including deviations, CAPAs, and change control.
• Support regulatory inspections and internal audits.
• Identify and escalate compliance risks and support implementation of corrective actions.
• Monitor and report KPIs such as: Testing turnaround time Material disposition cycle time Supplier performance Investigation timelines
• Drive continuous improvement initiatives to enhance efficiency and compliance.
• Support implementation of scalable systems and processes to meet organizational growth.

Benefits

• Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life.
• Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
• discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, wellness and transportation benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed
• Number of Employees: 501-1,000 employees