Director of Raw Materials Quality - Site Based, Redmond, WA
Evotec
8 months ago
On-site
Redmond, WA
Operations
Director, Raw Materials Quality
What You’ll Do
- Lead the Raw Materials Quality function, including QC Raw Materials Testing, Raw Material Lot Disposition, and Supplier Quality Management
- Manage and develop managers and team leads responsible for day-to-day operations
- Ensure effective execution of raw material quality activities to support 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, and raw material lot disposition
- Apply risk-based approaches to raw material control aligned 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 to ensure compliance with GMP requirements
- Ensure materials are sampled, tested, and reviewed per approved procedures and timelines
- Oversee analytical testing programs (e.g., FTIR, HPLC, pH, etc.) and ensure methods are qualified/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 and ensure timely release to support manufacturing
- Ensure appropriate review of certificates of analysis, supplier documentation, analytical testing results, and qualification status; ensure disposition decisions are documented in quality systems
- Lead Supplier Quality activities across the supplier lifecycle (qualification, monitoring, requalification)
- Oversee supplier audits and ensure timely closure of observations
- Manage supplier-related quality events (deviations, complaints, CAPAs, change controls)
- Monitor supplier performance metrics and drive improvements
- Ensure all activities comply with FDA, EMA, ICH, and internal quality systems; adhere to deviations, CAPAs, and change control
- Support regulatory inspections and internal audits; identify and escalate compliance risks and support corrective actions
- Monitor and report KPIs (testing turnaround time, material disposition cycle time, supplier performance, investigation timelines)
- Drive continuous improvement and support implementation of scalable systems and processes
Experience
- 8+ years in Quality, QC, or Supplier Quality in a GMP-regulated pharmaceutical/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
Technical Knowledge
- 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
Skills and Competencies
- Strong leadership and team management
- Effective cross-functional collaboration
- Solid problem-solving and decision-making
- Ability to manage competing priorities in a GMP environment
- Strong communication and organizational skills
- Attention to detail and commitment to quality
Benefits (as stated)
- Base pay range: $141,120 to $193,200 (salary exempt)
- Discretionary annual bonus
- Medical, Dental, Vision
- Short-term and long-term disability
- Company-paid basic life insurance
- 401k company match
- Paid time off and paid holiday
- Wellness and transportation benefits
Application Instructions
- Apply today.
What You’ll Do
- Lead the Raw Materials Quality function, including QC Raw Materials Testing, Raw Material Lot Disposition, and Supplier Quality Management
- Manage and develop managers and team leads responsible for day-to-day operations
- Ensure effective execution of raw material quality activities to support 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, and raw material lot disposition
- Apply risk-based approaches to raw material control aligned 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 to ensure compliance with GMP requirements
- Ensure materials are sampled, tested, and reviewed per approved procedures and timelines
- Oversee analytical testing programs (e.g., FTIR, HPLC, pH, etc.) and ensure methods are qualified/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 and ensure timely release to support manufacturing
- Ensure appropriate review of certificates of analysis, supplier documentation, analytical testing results, and qualification status; ensure disposition decisions are documented in quality systems
- Lead Supplier Quality activities across the supplier lifecycle (qualification, monitoring, requalification)
- Oversee supplier audits and ensure timely closure of observations
- Manage supplier-related quality events (deviations, complaints, CAPAs, change controls)
- Monitor supplier performance metrics and drive improvements
- Ensure all activities comply with FDA, EMA, ICH, and internal quality systems; adhere to deviations, CAPAs, and change control
- Support regulatory inspections and internal audits; identify and escalate compliance risks and support corrective actions
- Monitor and report KPIs (testing turnaround time, material disposition cycle time, supplier performance, investigation timelines)
- Drive continuous improvement and support implementation of scalable systems and processes
Experience
- 8+ years in Quality, QC, or Supplier Quality in a GMP-regulated pharmaceutical/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
Technical Knowledge
- 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
Skills and Competencies
- Strong leadership and team management
- Effective cross-functional collaboration
- Solid problem-solving and decision-making
- Ability to manage competing priorities in a GMP environment
- Strong communication and organizational skills
- Attention to detail and commitment to quality
Benefits (as stated)
- Base pay range: $141,120 to $193,200 (salary exempt)
- Discretionary annual bonus
- Medical, Dental, Vision
- Short-term and long-term disability
- Company-paid basic life insurance
- 401k company match
- Paid time off and paid holiday
- Wellness and transportation benefits
Application Instructions
- Apply today.