This position will report to the Chief Executive Officer (CEO). The position will provide leadership for the Quality Assurance and Quality Control departments to ensure the successful development, implementation and maintenance of all quality systems within ABL, Inc. This position will be responsible for overseeing quality operations at European facilities, and ensuring compliance to company procedures as well as regulatory agency requirements.
This position is responsible for ensuring that established procedures are followed or revised to meet regulatory requirements, including documentation control, management review, training, CAPA, production and process control, equipment calibration, supplier control, and validation.
As the leader of the Quality Program at ABL, Inc., this position is responsible for the overall quality functions for the organization on a global basis and for the formulation and execution for ABL’s quality strategy to include, but not limited to the development and optimization of processes and procedures that meet quality standards. The incumbent will ensure adherence to ABL GXP (cGMP/GLP/GCLP) Quality System and Regulatory standards, internal audits, sub-contractors’ quality, third party cGMP/GLP evaluations and approval. The incumbent will provide support and promote collaboration internally to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines. The incumbent will also provide leadership through contributions to strategic planning, development, implementation, and management of Quality Assurance and Quality Control operational processes, systems, tools, and best practices. This position is expected to be a subject matter expert for all areas related to quality assurance and quality control.
• Oversee and direct the Global Quality Organization including Quality Assurance Operations and Quality Control Departments to assure compliance with client and regulatory requirements.
• Collaborate with key stakeholders in Scientific Operations; Project Management, Manufacturing, and Regulatory to ensure robust quality support and oversight are in place to further project objectives.
• Responsible for developing the quality strategy with understanding of requirements during the early phases of clinical vaccine development.
• Develops and executes short and long-term strategies and objectives for the quality function with an outlook to refine and realign of the systems as needed.
• Develop and implement cGMP & GCLP systems and procedures including SOPs, policies, forms, and tools such as excel spreadsheets or reports.
• Identify and communicate quality or compliance risks and participate in the determination of appropriate plans to address risks.
• Provide leadership to ensure all GXP required validation is performed for process, tests, equipment and facilities to meet industry or regulatory expectations.
• Participate in Management Team meetings and represent quality department concerns. Keep management informed about compliance/quality concerns, QA/QC projects, and issues with stability results.
• Establish key objectives and metrics for evaluation of the effectiveness of the Departments and supporting functions and lead Quality Management Reviews.
• Develop and manage strategic plans and budgets for global quality operations.
• Advanced degree (Master’s or Ph.D.) in a relevant scientific field with experience in a technical or administrative field related to the industry or equivalent.
• Minimum of 15 years of related professional experience in Quality Control/ Quality Assurance for biologics with a strong technical foundation in a cGMP environment is required. Solid record of increased responsible positions in research and development preferred.
• Minimum 10 years of leadership/supervisor/management experience involving a staff of a minimum 5 professionals (or equivalent combination of related education and experience) in a cGMP environment.
• Demonstrate ability to build relationships and work collaboratively with a variety of individuals within the department, company and external vendors, and customers alike
• Demonstrate ability to work in fast-paced, team-oriented and self-directed entrepreneurial environment.
• Demonstrate strategic planning with proven ability to communicate a vision and drive results.
• In-depth knowledge of cGMP’s, FDA regulations (21 CFR Parts 210, 211) and EU regulations and practical experience in auditing practices and procedures.
• Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators
• Ability to influence and motivate others while maintaining a cohesive team environment.