Director, Quality Control Analytical Sciences and Technology

Avid Bioservices•Tustin, CA

18h•Onsite

About The Position

Provides scientific and strategic leadership for analytical method lifecycle management within Quality Control. Accountable for ensuring analytical methods remain fit-for-purpose throughout their operational lifecycle through data-driven performance monitoring, investigation of method-related quality events, statistical trending, continuous improvement, and governance of analytical control strategies. Serves as the primary escalation point for complex OOS/OOT investigations, recurring invalid assays, adverse trends, and emerging method performance risks.

Requirements

B.S. in Chemistry, Biochemistry, or Biology or related field with a minimum of 10 years of industry experience in a QC or analytical laboratory.
Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits.
Knowledge of FDA guidelines, USP, EP, EU Annexes, and ICH guidelines

Nice To Haves

MS or higher degree preferred.
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Responsibilities

Provide strategic oversight of all GMP analytical methods throughout their operational lifecycle to ensure methods remain fit-for-purpose, compliant, and aligned with product and business needs.
Establish method ownership, lifecycle review processes, and performance governance.
Lead scientific assessment and approval of method changes, revisions, requalifications, and retirement activities.
Drive continuous improvement initiatives to enhance method robustness, reliability, and operational efficiency.
Serve as the highest-level scientific authority for analytical quality events and complex laboratory investigations.
Provide oversight and approval of significant OOS, OOT, deviation, atypical result, and recurring invalid assay investigations.
Lead root cause analyses involving methods, instrumentation, reagents, standards, training, and laboratory systems.
Identify systemic issues and implement sustainable corrective and preventive actions across the QC organization.
Establish a proactive analytical monitoring program that uses data and statistical tools to ensure continued assay control and detect emerging risks.
Oversee control chart trending and monitoring of critical assay performance attributes, system suitability metrics, and laboratory performance indicators.
Evaluate trends, shifts, and recurring events to identify opportunities for risk mitigation and process improvement.
Develop and communicate analytical health metrics, dashboards, and periodic management reviews to QC leadership.
Build and lead a high-performing scientific organization that provides advanced technical support to QC Operations and the broader business.
Lead, develop, and prioritize the work of the AS&T team while ensuring appropriate resource allocation and succession planning.
Partner with QC Operations, Analytical Development, MS&T, QA, Regulatory Affairs, and clients on analytical strategy and issue resolution.
Serve as the analytical SME during inspections, audits, client interactions, regulatory submissions, and strategic business initiatives.
Directs activities of functional areas through direct reports.
Represents Quality Control in interdepartmental meetings.