The Role:

The Associate Director, Quality Assurance External Manufacturing will be responsible for the quality oversight of critical components, cell banks, starting materials, intermediates, drug substance and drug product produced by Contract Development and Manufacturing Organizations (CDMOs) throughout the product lifecycle. This includes quality oversight for the selection, qualification and routine monitoring of Contract manufacturers and laboratories.  This quality role will closely partner with internal and external operational stakeholders and participate in associated governance for the successful planning and execution of CMC outsourcing strategies.

Here’s What You’ll Do:

• Serve as the primary Quality contact for contract development and manufacturing organizations selected by ElevateBio for outsourced manufacturing activities.
• Participate in cross functional teams to establish and enhance the quality systems and support for managing high levels of quality compliance at contract manufacturers.
• Build strategic relationships with CDMOs within the Quality organization and participate in Business Review Meetings to ensure Quality issues are identified, managed, addressed and escalated as necessary.
• Establish, maintain and monitor, supplier files including Quality Agreements with CMOs and directly related suppliers to the CMOs.
• Liaise with cross-functional teams for external quality commercial operations, project management and stakeholders in support of GMP manufacturing and testing activities, including disposition of contract manufactured materials.
• Responsible for the quality review and approval of batch records, SOPs, change controls, deviations and CAPA for development, clinical and commercial processes, assess impact and provide quality oversight of implementation activities.
• Support root cause analysis and product impact assessments for investigations resulting from deviations and OOS events.
• Monitors quality processes, metrics and drive quality remediation and continuous improvement activities.
• Work closely with the Quality Compliance and Supplier Quality function to establish the audit strategy for Auditing and Supplier Performance monitoring and support technical site audits, including preparation for regulatory inspections.
• Work across the company to establish CDMO quality oversight processes including qualification, risk categorization and routine monitoring.
• Provide guidance and support through Quality representation at periodic intervals on-site at the CDMOs.

Requirements:

• Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 8 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
• Ability to communicate and work independently with scientific/technical personnel.
• Strong knowledge of GMP, SOPs, and quality system processes.  
• Experience with Root Cause Analysis, data analytics, and other Operational Excellence experience
• Excellent communication skills and ability to Influence and promote a culture of Quality and Excellence.
• Demonstrated application of risk management principles to decision making and operational priorities.
• Critical Thinking and Problem-Solving skills.
• Strong leadership and an innate ability to collaborate and build relationships.
• Excellent organizational and communication skills.
• Up to 20% travel

Preferences:

• Experience in advanced therapeutics, cell and gene therapy manufacturing
• Experience performing manufacturing and laboratory investigations
• Experience in QA batch disposition
• Experience with CDMO quality and operations