Director / Associate Director, Quality Control

Responsibilities

• Perform GMP IPC, lot release, and stability testing using ddPCR, flow cytometry, and/or cell-based methods.
• Facilitate and perform method optimization, transfer, qualification, and validation for manufacturing in-process control (IPC), lot release, and stability testing of clinical drug product within a GMP environment. 
• Describe results in detailed and organized presentations and reports.
• Participate in cross-functional training, as well as identifying and facilitating continuous method and process improvements.
• Develop, implement, maintain, and continually assess the Company’s QC function and Quality Management System (QMS) for applicable regulated activities to meet internal company standards and external global regulatory requirements.
• Lead and support strategic planning by timely communication of QC deliverables, constraints, risks and options, and collaborating with Analytical Development, Quality Assurance, Program Management, Regulatory Affairs, Technical Operations, and CMOs.
• Oversee product stability study design, monitoring, reporting, and data trend-analysis, as well as support product release, within a GMP environment.
• Oversee QC elements of raw materials qualification program.
• Establish robust analytical development strategies, inclusive of method qualification and validation, to ensure product quality and meet regulatory requirements.
• Generate stability specifications for raw materials and products, and support generation of release specifications and Certificates of Analysis.
• Manage method transfer and outsourced testing activities with Contract Manufacturing Organizations (CMO).
• Write, review, and/or approve, methods, protocols, and validation reports.
• Write, review and/or approve deviations, investigations, and CAPAs both within the Company and with CMOs.
• Establish, administer, and maintain policies, standard operating procedures (SOPs), work instructions, and forms relating to the QC function and the QMS.
• Author and review CMC analytical sections for regulatory submissions and annual reports.
• Perform periodic internal QC system reviews and audits, as well as participate in preparing for and representing QC in regulatory inspections.
• Implement, perform and oversee internal quality auditing of QC function (including applicable vendors or subcontractors), customer quality audit response, and other QC related quality management system activities.
• Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the QC function and the QMS remain in compliance with applicable company requirements and global regulations.

Qualifications

• Bachelor's degree in Biology or related discipline, with a minimum of 8 years in biotechnology, clinical, or pharmaceutical QC laboratory experience is required; advanced degree is preferred.
• Experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is required, with strong knowledge of FDA, ISO, EMA, GMP and ICH requirements applicable to biologics and cell therapies.
• Proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, and excellent interpersonal, organizational, and written and oral communication skills.
• Leadership and management skills to grow and manage a high performing team.
• Experience running multicolor flow cytometry, with working knowledge of flow cytometers and FlowJo.
• Experience running dd