Senior Director, Quality Assurance & GxP Strategy

BioSpace; San Diego (CA); Vor Ort; USD 187.000 - 229.000; Vollzeit

Benefits dieser Stelle

Medical/Dental insurance

Onsite gym

Generous time-off

Zusammenfassung

Aspen Neuroscience, Inc., headquartered in Torrey Pines, is seeking an Associate Director of Quality Assurance to lead strategic and operational quality efforts across late-stage development, manufacturing, and commercial readiness.

You will shape risk-based governance, oversee multiple QA functions, and partner with senior leaders to ensure GMP, GCP, and GLP compliance. This on-site role requires flexibility for weekend work and travel as needed in San Diego.

Qualifikationen

• Bachelor's degree in life sciences, health sciences, engineering, or related field required; advanced degree preferred.
• 8+ years of substantial cGMP pharmaceutical/biotech quality leadership in clinical/manufacturing.
• Experience in late-stage development, commercial manufacturing readiness, biologics, or cell therapy preferred.
• 7+ years leading audits and inspection-readiness; CQA or equivalent preferred.
• 7+ years of progressive people leadership, developing teams and managing performance.

Aufgaben

• Lead strategy and governance for GxP quality systems across clinical and manufacturing.
• Oversee multiple QA functions: document control, training, supplier quality, events, audits, batch disposition.
• Ensure compliant execution of core QMS processes and investigations.
• Establish metrics and dashboards to monitor quality health and drive remediation.
• Prepare the organization for enterprise inspections and audits; manage responses.
• Develop QA talent through coaching and succession planning.

Kenntnisse

Quality leadership

Executive communication

Cross-functional leadership

Risk-based decision making

Audit readiness

Ausbildung

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

Electronic quality management systems

Electronic batch record systems

Jobbeschreibung

Aspen Neuroscience, Inc., headquartered in Torrey Pines, is seeking an Associate Director of Quality Assurance to lead strategic and operational quality efforts across late-stage development, manufacturing, and commercial readiness.

You will shape risk-based governance, oversee multiple QA functions, and partner with senior leaders to ensure GMP, GCP, and GLP compliance. This on-site role requires flexibility for weekend work and travel as needed in San Diego.