Sr. Manager, Quality Operations
$139,250–$184,000 year
On-siteLos Angeles, California, United States or Northridge, California, United States
Job Summary
Define and implement the Quality Operations Program, leading a team of direct reports through hiring, performance management, and disciplinary actions. Serve as the primary quality decision-maker for manufacturing issues, providing real-time direction on quality pathways and resolving escalated deviations with independent containment and corrective actions. Oversee all minor deviations, investigations, and CAPA records to ensure regulatory-compliant root-cause analysis and timely closures. Lead cross-functional corrective actions for systemic issues and represent the department during regulatory inspections and customer audits. Drive quality improvement initiatives using Lean and Six Sigma methodologies while managing departmental budgets and resource plans. Maintain a constant state of audit readiness through internal audits and metric reviews to support site and corporate quality objectives.
Required Qualifications
- Bachelor's degree or higher in Engineering, Life Sciences, or a related technical discipline
- Minimum 10 years in a pharmaceutical, medical device, or similarly regulated manufacturing environment
- Minimum 7 years managing technical staff (quality, engineering, or manufacturing), including demonstrable experience leading teams of 3+ FTE
- Proven involvement in hiring, disciplinary actions, and termination recommendations
- Deep expertise in GMP, manufacturing processes, quality systems, deviation/CAPA, and equipment/process troubleshooting
- Ability to make independent technical decisions that impact compliance, product quality, and customer commitments
- Strong communication skills with the ability to represent site quality operations to senior management, regulatory inspectors, and external customers
- Proficiency in Lean/Six Sigma methodologies and data-driven decision-making
- #LI-Onsite
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