S/he is responsible for managing all QC functions, working with cross-departmental leadership to deliver high quality results across all laboratory functions. Build and develop a professional and efficient QC team to establish and maintain a quality system within QC functions to ensure compliance to latest regulatory and health authorities requirements.

Responsibilities:

• Leads Quality Control laboratories including Bioassay, Microbiology, PCR, and Biochemistry laboratories to ensure the testing is performed according to the regulatory requirements and internal procedures.
• Establishes new QC laboratory policies and procedures to ensure the laboratory process and operations in compliance with the regulatory requirements and operational efficiency.
• Ensures all Quality Control laboratory operations comply with FDA cGMP parts 211 and 600, international regulatory GMP requirements, and relevant ICH guidance for the Biotech industry.
• Establish and maintain method validation and transfer programs to ensure that methods used in the QC laboratories for pivotal clinical trials and commercial products are properly validated, qualified, or transferred.
• Develop validation master plan for analytical testing methods and lead the execution of assay validation according to FDA/ICH guidelines and compendium requirements, including methods for cleaning validations. Ensuring phase appropriate regulatory expectations are followed.
• Ensures continuous improvement and effectiveness of the quality control laboratories.
• Establish and maintain stability programs (SOPs) to comply with regulatory requirements for products at preclinical stage to commercial stage.
• Oversee all testing for in-coming materials, in-process materials, finished products, and stability samples to ensure all testing done on time by properly allocating workload, and cross-train staff on different quality areas.
• Manages the relationship with Contract Laboratories Organizations engaged in the testing and release of raw materials, critical excipients, in-process, finished products and stability samples in behalf of CARsgen. Assures oversight and compliance to CARsgen’s policies and procedures.
• Establish and maintain the environmental monitoring programs (SOP) for the entire site to ensure compliance with global regulatory requirements.
• Oversee the execution of the environmental monitoring program from initial qualification of facilities and utilities to the routine operations. Provide support to the manufacturing operations during investigations and feedback for continuous improvement.
• Establish and maintain OOS and OOT program (SOP) to ensure that OOS and OOT are thoroughly investigated and CAPA plans to resolve the OOS and/or OOT are developed and executed.
• In charge of the QC Lab’s EHS, especially biosafety and chemical safety, for all the laboratory operations to meet the national and location EHS requirements.
• To shape and develop a fit for purpose organization and an inclusive high performing business team, continuously improve team efficiency through effective management methods, such as fair and objective performance evaluation on the team members and effective internal communication.
• Achieve financial objectives by preparing the quality control laboratory budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
• Maintain professional and technical knowledge by reviewing regulatory guidance and professional publications, establishing personal networks, and participating in professional societies.
• Complete other duties assigned by the leader.

Qualifications:

• Bachelor’s Degree or above in life sciences or a related field with a minimum of 10 years’ work experience in the pharmaceutical or biotechnology industry.
• At least 5 years of senior management experience in a biotech (biologics) industry, sterile or recent cell therapy experience laboratory is preferred.
• Experience in hosting FDA, EMA, HC and other regulatory/health authority inspections.
• Excellent written and oral communication skills
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment.
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
• Goal oriented with the ability to troubleshoot and resolve complex laboratory investigations and problems.
• Experienced implementing lean laboratory and continuous improvement initiatives.
• Strong interpersonal skills, with experience in leading high-performance team and cross functional projects.
• Team building and managing skills including recruiting, coaching, counseling, and disciplining.