Senior Director, Quality Assurance - Remote

Overview

The Senior Director, Quality Assurance (QA) is responsible for ensuring that manufacturing and quality operations comply with all regulatory and internal standards, leading QA/QC teams, managing audits and inspections, and driving continuous improvement across GMP processes.

In Short

• Oversee all GMP activities to ensure compliance with regulatory requirements (FDA, EMA, ICH, etc.) and internal quality standards.
• Maintain and organize GMP related documentation, systems and programs records.
• Manage and execute the GMP audit programs, including conducting qualifications audits, supporting investigations and ensuring inspection readiness.
• Provide leadership and direction for QA and QC teams, including hiring, training, and performance evaluations.
• Approve batch disposition, deviations, change controls, and corrective and preventive actions (CAPA).
• Lead cross-functional teams to resolve complex quality and compliance issues, drive continuous improvement, and implement process optimization.
• Maintain and improve Quality Management Systems (QMS) ensuring effective management of batch records, audits, investigations, and compliance metrics.
• Collaborate with internal and external partners to ensure manufacturing processes meet GMP standards and regulatory expectations.
• Prepare and present updates on quality performance, risks, and issues to senior management.
• Oversee regulatory inspections and responses, and ensure training programs are in place for GMP compliance.

Requirements

• B.S./M.S. in life science, biotechnology or a related field.
• Extensive experience 10-15+ in GMP, quality assurance, or manufacturing within the biotechnology or pharmaceutical industry standards.
• Strong leadership, communication, and problem-solving skills.
• Able to work effectively with cross-functional teams.
• Veeva experience a plus.

Benefits

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package.