Responsibilities

• Manage and lead the Quality Compliance group including quality systems, inspection management training, and operations regulatory compliance
• Ensure the implementation and maintenance of the Cellares Quality
• Management System at Bridgewater with the goal of maximizing efficiency, effectiveness and compliance with all applicable GMP regulations
• Direct the compliance programs for all cGMP areas and promote a strong Quality culture within the global organization including a strong presence in Quality, Manufacturing, MSAT, Supply Chain and Purchasing, Analytical Development, Process Development, and Engineering
• Ensure adherence to Cellares’ Quality System, regulatory standards and Federal laws
• Support tech transfer of late stage/commercial cell therapy products and equipment coming through the organization pipeline
• Serve as key lead during team and other technical forums with respect to compliance and regulatory strategies
• Provide Quality direction and strategy for operational issues or technical challenges
• Manage and oversee the Document Management System & Data Integrity programs for paper and electronic based systems ensuring compliance with 21 CFR Part 11 regulatory standards
• Prepare and host periodic Quality Management Reviews to assess the effectiveness of the Quality Systems; identify unfavorable trends and collaborate with site stakeholders and functions to ensure their timely mitigation
• Evaluate, contribute, and approve change controls, risk assessments, quality events, CAPAs, and other investigations as they relate to compliance and technical challenges and implementation plans
• Contribute to CMC sections of regulatory filings, proprietary reagent filings, and other regulatory filings including client and business support paths
• Key lead during site preparation of regulatory and customer inspections including personnel preparation and training
• Collaborative host of regulatory and customer inspections and audits
• Preparation and approval of follow up activities including responses, commitments, CAPAs, and other strategy plans
• Manage and oversee the self inspection and internal audit programs
• Perform and collaborate on global Quality audits with respect to internal and external customers
• Responsible for the GMP Training program and ensuring its ongoing effectiveness and alignment with GMP job functions and job descriptions
• Review and approve SOPs, manufacturing batch records, specifications, validation protocols and reports, instrument acquisitions, impact, and decommissioning, work orders, and other Quality operations as needed
• Collaborate with functional area leads during planning and process/continuous improvement plans, projects, and gap assessments as they relate to proprietary instruments and manufacturing operations
• Oversee and monitor Quality metrics ensuring data is understandable and translatable to the appropriate audience(s)
• Mentor, coach, and manage staff performance and development

Requirements

• Bachelor’s degree or higher in a scientific or engineering discipline
• 10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
• 5+ years of leadership experience, and demonstrated knowledge of relevant cGMP regulations
• Excellent knowledge of the regulations for biologics, cell and gene therapy products
• Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is required
• Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
• Hands-on experience with designing and implementing GMP Quality Systems
• Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
• Demonstrated experience in preparing regulatory submissions and response to health authorities queries

90000 - 210000 USD a year