Senior Director, Development Quality Assurance

The role

The Senior Director, Development Quality Assurance implements and executes quality assurance strategies to support clinical development activities. This role ensures compliance with GCP, GLP, GVP, and global regulatory requirements while partnering with various development functions.

What you will do

• Execute Development QA objectives and priorities.
• Partner with Development functional leaders to promote a culture of quality and compliance.
• Provide quality guidance to leadership regarding risks, compliance, and inspection readiness.
• Develop and maintain quality metrics, risk indicators, and dashboards.
• Manage a risk-based audit program for clinical programs, vendors, and development activities.
• Lead or oversee internal and external audits of clinical sites, CROs, laboratories, and vendors.
• Lead and coordinate operational inspection readiness activities.
• Lead the development, review, and implementation of Development SOPs and guidance documents.
• Support qualification and oversight of CROs, laboratories, and other external partners.
• Drive harmonization of quality processes across Development and Manufacturing organizations.

Required qualifications

• Bachelor's or Master's degree in Chemistry, Biochemistry, Clinical Pharmacology, Life Sciences, or related field.
• Minimum of 15 years of experience in biotechnology, pharmaceutical, or life sciences, quality assurance, clinical development, or related GxP-regulated environments.
• Minimum of 5 years of leadership experience managing quality professionals and supporting quality systems, inspection readiness, compliance programs, and quality oversight activities.
• Demonstrated experience building, implementing, or improving Quality Management Systems and quality processes.
• Significant experience supporting global clinical development programs and regulatory inspections.
• Deep knowledge of GCP, GLP, GVP, FDA, EMA, ICH guidelines, and global regulatory requirements.
• Strong understanding of risk-based quality management principles and QMS processes.
• Experience developing, reviewing, and implementing SOPs, standards, and guidance documents.
• Experience supporting Health Authority inspections, Serious Breach assessments, and CAPA management.
• Strong communication, analytical, organizational, and problem-solving abilities.
• Strong project management, change management, and organizational effectiveness skills.
• Proficiency with electronic Quality Management Systems such as TrackWise, MasterControl, Veeva Quality, or equivalent.

Nice to have

• Experience with biologics, antibody-drug conjugates (ADCs), radiopharmaceuticals, and/or small molecule development

Benefits

• Medical, dental, and vision insurance coverage for employees and dependents
• 100% company-paid medical premiums for employees
• 401(k) with employer match
• Employer-paid life insurance, short- and long-term disability insurance, and AD&D
• Paid time off
• Company holidays
• A week-long winter break between Christmas and New Years
• Paid parental leave

About the company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The company is advancing an innovative portfolio of therapeutics, including antibody-drug conjugates.