Director, Quality Control

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

Your Role: The Director, Quality Control p rovides 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.

Key Responsibilities:

Analytical Method Lifecycle Governance

• 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.

Investigation and Scientific Problem Resolution

• 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.

Analytical Performance Monitoring and Data Analytics

• 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.

Organizational Leadership and Cross-Functional Partnership

• 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.
• Occasional overnight travel by land and/or air may be required to attend seminars or conferences or client meetings

Minimum Qualifications:

• 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. MS or higher degree preferred.
• 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

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $173,136 - $216,421 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• 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.

Physical Demands & Work Environment: