Director, GMP QA

SUMMARY

This individual will lead the GMP quality assurance duties for the company. He/she will be responsible for assuring that company and all contract manufacturing groups for which the company has oversight, adhere to required cGMP regulations, particularly for the National Medicinal Products Association (NMPA) of China. The individual should be capable of developing quality management system(s) relevant and stage-appropriate for a Phase 2/3 biotechnology company which is building towards commercialization over the next 4-5 years. The individual will also be responsible for building and leading an internal GMP QA team appropriate for a License B MAH holder as the company gets closer to registration filing.

DUTIES AND RESPONSIBILITIES

• The person responsible for quality management is fully accountable for the quality of the drugs.
• Establish and maintain a quality management system to ensure that the system complies with GMP requirements.
• Ensure that the company’s quality control, Tech Ops, and quality assurance personnel have undergone necessary training and continued training. Ensure that all relevant personnel in the contracted enterprises involved in manufacturing and quality management have received necessary ongoing training. Adjust training content based on actual product and process needs.
• Oversee the GMP vendor management process, update the GMP vendor audit plan, maintain an approved vendor list, conduct on-site audits, quality evaluations, and periodic re-evaluations of vendors; draft quality agreements.
• Responsible for coordinating the evaluation of external GMP documents, e.g. protocols, reports, batch records, methods. 
• Responsible for collecting GMP quality management review information, analyzing quality data trends, and reporting quality trends to management.
• Ensure that raw and auxiliary materials, packaging materials, intermediate products, products waiting for packaging, and finished products meet the requirements and quality standards described in the regulatory filings.
• Review and approve technical transfer documents, analytical methods and validation protocols, master batch records, etc for clinical stage products.
• Approve quality standards, sampling methods, inspection methods, and other quality management procedures, as applicable; review and approve product process procedures, operational procedures, and other documents.
• Ensure that product release batch data review is completed before the product is released to the clinic.
• Review and approve all quality-related changes, deviations, and OOS investigations; ensure that all deviations, changes, and OOS results have been investigated and handled in a timely manner in accordance with the quality agreement with the CDMO or laboratory.
• Approve pharmaceutical contract manufacturing quality agreements, and organize and supervise the contracted party’s production and quality management activities, ensuring compliance with the terms of the agreement. Provide phase-appropriate quality oversight of all aspects of contracted manufacturing and analytical testing/release including equipment validation, cleaning, stability and process validation. 
• Ensure that all complaints related to approved product quality have been investigated and handled promptly and correctly.
• Work with Tech Ops team to ensure that the contracted enterprise completes the ongoing stability study plan for products and provides stability study data.
• Participate in drug R&D and technical transfer, and review the plans and conclusions for new product development and process improvements.
• Coordinate external quality audits on behalf of the company; ensure that CDMOs have the appropriate regulatory licenses to conduct contracted services.
• Serve as the primary contact for quality-related issues with the contracted manufacturing or laboratory organization.
• Serve as the primary contact for receiving quality audits from regulatory bodies and internal or external parties.
• Manage the company’s quality team, provide feedback and guidance on team members’ work performance and professional development, and perform performance management of the quality team.

QUALIFICATIONS

• Bachelor’s degree in pharmacy or a related field 
• More than 10 years of practical experience in drug development, manufacturing and/or quality management. Ideal candidate has prior leadership experience in GMP QA.
• Experience in GMP quality document management and auditing.
• Experience in development and manufacture of biologics (i.e. familiarity with processes, equipment, facilities) is preferred. Experience in sterile products is required.
• Experience in management and oversight of CDMOs and associated quality documentation. Must be able to work closely with CDMOs to identify and address issues and improve vendor quality systems.
• Familiar with domestic and international GMP, GLP and other regulatory requirements.
• Computer skills required: Spreadsheet Software (Excel); Word Processing Software (Word); Electronic Mail Software (Outlook); Presentation software (PowerPoint); some familiarity with eQMS system(s).  Knowledge of Veeva Quality Docs is preferred but not required. 
• Good English reading and writing skills.
• Ability to gain the respect and confidence of other team members.  Must be able to collaborate with other functional areas.
• Have a high level of energy, positive attitude, and possess a selfless attitude for the benefit of the firm.
• Must contribute to the firm and the profession in a meaningful, substantive way.
• Must demonstrate a clear talent for understanding, motivating and inspiring our partners, consultants, and staff.
• Must be an integral and recognizable part of the firm reputation and image.
• Strong attention to detail, quality, and time management.
• Requires critical thinking skills, communication skills (verbal and written) and interpersonal skills.