Senior QA Leader, GxP for Late-Stage Biotech

Aspen Neuroscience, Inc.; San Diego (CA); On-site; USD 187,000 - 229,000; Full time

Benefits offered by this job

Onsite gym

Medical/Dental insurance

Company holidays

Job summary

Aspen Neuroscience, Inc. in San Diego, CA is seeking an Associate Director of Quality Assurance to lead and evolve GxP quality systems across late-stage development, manufacturing, and commercial readiness.

The role focuses on risk-based governance, regulatory compliance, and strong QA partnerships with senior leadership. You will oversee document control, training, supplier quality, deviations and CAPA processes, audit readiness, and batch disposition while guiding cross-functional teams and

Qualifications

• Bachelor's degree in life sciences, health sciences, engineering, or related field required; advanced degree preferred.
• Minimum 8 years of substantial experience in the cGMP pharmaceutical or biotechnology industry and progressive leadership of GxP quality systems.
• Late-stage clinical development, commercial manufacturing readiness, biologics, cell therapy, or stem cell manufacturing experience strongly preferred.
• Minimum 7 years of experience leading audits and inspection-readiness activities; CQA or equivalent certification preferred.
• Minimum 7 years of progressive people leadership experience including developing teams and managing performance.
• Experience with electronic quality management systems and electronic batch record systems preferred.

Responsibilities

• Lead strategy and operating model for GxP quality systems across clinical development, manufacturing, and commercial readiness.
• Drive governance, budgets, and measurable outcomes for QA areas.
• Shape policies and risk-based quality practices influencing product quality and compliance.
• Direct multiple QA functions: document control, training, supplier quality, quality events, audits, and batch disposition.
• Ensure timely execution of core QMS processes and guide investigations and remediation.
• Establish metrics and dashboards to assess quality health and drive risk-based decisions.
• Lead inspection readiness and manage internal, external, partner, and regulatory audits and responses.
• Communicate risks and performance to senior leadership and align cross-functional stakeholders.
• Develop QA talent through clear accountability and coaching to build a high-performing culture.

Skills

GxP Quality Leadership

Audits & Inspection Readiness

Cross-functional Leadership

Quality Systems Strategy

Education

Bachelor's degree in life sciences or related

Advanced degree preferred

Tools

Electronic Quality Management Systems

Electronic Batch Record Systems

Job description

Aspen Neuroscience, Inc. in San Diego, CA is seeking an Associate Director of Quality Assurance to lead and evolve GxP quality systems across late-stage development, manufacturing, and commercial readiness.

The role focuses on risk-based governance, regulatory compliance, and strong QA partnerships with senior leadership. You will oversee document control, training, supplier quality, deviations and CAPA processes, audit readiness, and batch disposition while guiding cross-functional teams and