Director, Quality Control Lab

Job Type

Full-time

Description

The Director, QC Lab is accountable for the leadership activities and directing all facets of the Quality Control Lab activities, including but not limited to: sample management, reference standard, supply management, equipment management, certificate of analysis generation, QC data trending analysis, cGMP compliance and interaction with regulatory bodies.

• Provide leadership and direction to Quality Control supervisors and support teams to ensure high quality service. Drive continuous improvement.
• Excellent managerial skills as well as problem solving. Handle issues appropriately with a sense of urgency.
• Lead lab support topics in inspections conducted by external regulators and business partners.
• Manage and develop direct reports by setting clear expectations and resolving conflicts.
• Represents the department during high level discussions and investigations with external customers, vendors and FDA representatives.
• Responsible for building effective systems, processes, teams and managing through them for a smooth lab operation.
• Oversee the day to day operations of the Quality Control laboratory department to ensure accurate results, adherence to company protocols and timely completion of projects.
• Interface with different departments regarding quality issues, audits and special projects.
• Provide guidance to manufacturing regarding quality and cGMP issues to ensure compliance with regulated standards.
• Provide key leadership, vision and direction to the QC Lab while providing operational and technical expertise.
• Establish department operation schedule, plans, processes, budgets, departmental strategies, goals, objectives and metrics. Business continuity and long-term planning.
• Provide technical expertise for personnel training, deviations, CAPA, inventory management, cGMP compliance and data trending.
• Review and approve of OSS, SOPs, lab related investigations, stability failure notifications, COAs and compilation of stability related data.
• Review and approve of specifications and STM's for raw materials, packaging materials, in process and finished products.
• Observing and following general laboratory practices as specified in quality control SOPs
• Coordinate and supervise the collection of data reported in the product review.
• Prepare and review documentation required for regulatory submissions
• Review and authorize certificates of analysis and purchase requisitions.
• Serve on the Quality Task Force and participate in the generation and review of company standard operating procedures.
• Maintain metrics for the QC function and continuously improve the area in terms of quality, efficiency and effectiveness.
• Ensure the laboratory remains current with all changes to applicable compendia, regulations and guidance.

Requirements

• Minimum BA/BS in Biochemistry, Chemistry or related field
• Minimum 10 + years experience in QC within the biotech or pharmaceutical industry
• Management experience in Quality Control lab required
• Experience managing staff upwards of ~25 QC personnel, both as direct and indirect reports
• Responsibility includes training and developing direct reports and QC staff to keep abreast of current technology as it relates to QC function
• Ability to maintain integrity and honesty at all times
• Ability to communicate and lead with transparency, while working cross functionally
• Lead department for optimal performance and set course for future with clear set vision and goals
• Accountable for performance and results of department