Director, Quality Control Analytical Sciences and Technology
$163,000–$204,000 year
On-siteTustin, California, United States
Job Summary
Provide strategic oversight of all GMP analytical methods throughout their operational lifecycle to ensure they remain fit-for-purpose, compliant, and aligned with product and business needs. Serve as the primary escalation point for complex OOS/OOT investigations, recurring invalid assays, and emerging method performance risks by leading root cause analyses and implementing sustainable corrective actions. Establish a proactive analytical monitoring program using data and statistical tools to detect emerging risks, while developing dashboards and communicating health metrics to QC leadership. Build and lead the AS&T team, partnering with QC Operations, Regulatory Affairs, and clients on analytical strategy and issue resolution. Occasional overnight travel may be required for seminars or client meetings.
Required Qualifications
- B.S. in Chemistry, Biochemistry, or Biology or related field
- Minimum of 10 years of industry experience in a QC or analytical laboratory
- Experience with analytical testing and equipment
- Experience writing reports/procedures/specifications
- Knowledge of GMPs and regulatory audits
- Knowledge of FDA guidelines
- Knowledge of USP
- Knowledge of EP
- Knowledge of EU Annexes
- Knowledge of ICH guidelines
- Ability to work overtime and/or weekends when necessary
- Full-time onsite position availability
- Monday through Friday work schedule availability
- Ability to lift objects up to 25 pounds
- Essential visual acuity including close, distance, and color vision
Desired Qualifications
- MS or higher degree
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