Director, Quality Assurance
Reporting to the Head of Manufacturing Operations/Clinical Manufacturing Facility (CMF) Site Head, the Director of Quality Assurance is responsible for leading and strategically directing the Quality organization and is accountable for the continuous development, execution and administration of a GxP Quality System, meeting all compliance requirements with respect to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).
The Director of Quality Assurance will develop, maintain, and continually improve Quality Operations, the Quality Management System (QMS), the Quality Assurance program, and the Training Program. He/she will also provide overall Quality and Compliance oversight for the internal and external manufacturing and supply chain process supporting Codiak’s products, including the development of the Clinical Manufacturing Facility (CMF) in Lexington, MA.
Quality Management System
- Develop, implement and maintain Codiak’s QMS to ensure compliance with FDA/EMA/ICH and other applicable regulations and company standards.
- Ensure appropriate compliance and operational effectiveness in all areas of the QMS. including, design control, document control, change control, training, complaint handling, CAPA, and risk management.
- Establish eQMS system at Codiak.
- Develop, implement and maintain a GxP audit and monitoring plan, including establishment and management of related SOPs, a risk-based audit and monitoring schedule, and a CAPA effectiveness program.
- Manage audit program against GxP standards, FDA/EMA/ICH requirements, and other regulatory standards and ensure effective and comprehensive quality oversight of selected GxP and contract research/manufacturing vendors, including vendor assessment and selection, Vendor Audits, Quality Agreements, etc.
- Develop metrics for Quality at Codiak CMF and contract service providers.
- Establish and maintain appropriate development phase GMP compliance for product manufacture, testing, and stability; review and assess production and testing methods, specifications, validations, reference materials and test results.
- Manage Quality Assurance relationships with GMP service providers; work with CMO QA and technical teams to resolve discrepancies, and noncompliance events.
- Provide Quality oversight to release and distribution of Codiak products in alignment with regulatory guidelines.
- Review technical and study reports, CMC sections of regulatory submissions, pharmacy manuals, investigator brochures, study protocols and reports, as requested, for compliance with established standards, and regulations.
- Recommend solutions to complex quality issues and work closely with senior management to resolve significant compliance trends and issues.
- Act as subject matter expert and company representative during partner due diligence activities and regulatory inspections.
- Represent Quality Assurance in company project meetings to ensure regulatory and compliance requirements.
- Partnering with Human Resources, manage and deliver SOP and GxP related training to employees and external contractors, including oversight of training.
- Ensure robust planning and execution of documentation for product release.
- Bachelor’s degree, Master’s degree or PhD in science, pharmaceutical sciences or related field.
- Minimum 10 years of experience in Quality Assurance with at least 5 years of experience in GMP pharmaceutical development, manufacturing and testing.
- Preferred experience with complex biologics, Phase 1 through 3 stage product development. Technical knowledge of analytical method qualification, process validation and establishing product specifications a plus.
- Experience with outsourced manufacturing and testing operations, as well as internal manufacturing facilities.
- Experience in working in compliance with US, EU and ICH GMP requirements, experience reviewing submission documentation, responses to regulatory inquiries and inspections.
- Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
- Excellent oral and written communication skills, with an ability to shape, frame and present to diverse internal and external audiences.
- Strong interpersonal skills to effectively communicate with teams, peers, management and external contacts.
- Proven organizational and leadership skills to mentor and develop cross-functional team to achieve Company goals. Demonstrated ability to effectively lead professional staff
- Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.