Director, Quality Operations
$212,149–$239,998 year
On-siteBothell, Washington, United States
Job Summary
Oversee quality aspects of starting material, intermediates, drug substance, and drug product manufacturing, including packaging and labeling activities. Review and approve specifications affecting product quality, oversee master batch record development, and manage process and method validation reports. Disposition clinical and commercial batches and ensure effective CAPA management, change controls, and deviation handling during manufacturing and testing. Perform risk assessments, implement quality controls, and support vendor qualification programs while prompting management of potential compliance issues. Ensure external parties are inspection-ready for FDA or international regulatory audits, collaborate on regulatory submissions, and participate in Quality Management Review meetings. Drive continuous improvement initiatives to enhance operational efficiency and promote a strong quality culture across development and commercial stages.
Required Qualifications
- A minimum of 10 years of experience in Quality Assurance and GMP compliance within a pharmaceutical or biotechnology environment, or equivalent
- Extensive experience supporting outsourced manufacturing models, including oversight of CMOs and external service providers
- Experience working with small molecules and biologics
- Demonstrated senior-level experience leading global regulatory inspections and managing inspection outcomes
- Significant experience supporting development-stage programs through commercial operations
- Proven experience with internal and external audits, CAPA management, and continuous improvement initiatives
- Ability to travel up to 20% to support audits and regulatory inspections, domestic and international
- Deep technical knowledge of global GMP and GDP regulations, regulatory inspection expectations, and quality system requirements across development-stage and commercial operations
- Demonstrated expertise in inspection readiness, regulatory inspections, and inspection response management, including FDA Form 483 responses, commitments, and remediation strategies
- Strong understanding of quality systems, audit programs, CAPA management, recalls and risk-based compliance approaches in outsourced manufacturing environments
- Proven ability to lead quality governance, management/quality review processes, and regulatory surveillance activities
- Ability to assess, prioritize, and mitigate quality and compliance risks across CMOs, vendors, and internal operations
- Strong leadership presence with the ability to effectively influence executive leadership and cross-functional stakeholders
- Excellent verbal, written, interpersonal, and communication skills, with the ability to clearly convey complex quality and compliance topics
Desired Qualifications
- Experience working with small molecules and biologics (ideally ADCs)
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