Manager of Quality Assurance Operations
• Ensure that manufacturing operations at Contract Manufacturing Organization’s (CMOs) and vendors comply with regulatory requirements.
• Recruit, train, lead and mentor direct reports.
• Review and approve CMO documentation, including but not limited to master batch records, specifications, SOPs, validation protocols and reports.
• Review and approve product specifications, test methods, Certificates of Analysis, and stability protocols/reports
• Perform batch record review and disposition of clinical/commercial product.
• Manage (review, track, and close-out) in collaboration with CMOs, deviations, investigations, change controls, complaints, and corrective and preventive actions.
• Plan, oversee and/or conduct, and document, cGMP audits of CMOs, contract test labs and other vendors, as necessary.
• Provide quality as well as technical input to project teams.
• Partner with CMC Operations, Quality Control and Supply Chain to assess overall product quality performance, including the identification of any product-specific quality and compliance risks and develops mitigation plans based on a risk-based approach.
• Develop and maintain quality agreements and quality questionnaires.
• Perform vendor performance reviews.
• Assist with FDA and other regulatory agency inspections as needed.
• Bachelor’s degree is in Chemistry, Biology, or Life Sciences.
• Demonstrated knowledge of Quality Systems and cGMP within an FDA-regulated environment.
• Thorough knowledge of cGMPs/GDPs and global regulatory requirements.
• A minimum of 6 years direct QA experience in a cGMP environment.
• Ability to travel up to 20%.
• Auditing experience.
• Experience working with vendors, including large molecule/biologics/gene therapy is desired.
• Excellent organizational and time management skills with a high level of attention to detail.
• Excellent oral and written communication skills for effectively interfacing with internal and external organizations
• Enjoys working in a fast-paced, small-company environment.
• High levels of organization, attention to detail, and accuracy
• Exceptional interpersonal skills, with a focus on rapport-building, listening and questioning skills.
• Ability to execute assignments within established timeframes and quality standards, while responding to immediate needs.
• Ability to influence others and work independently and in a team environment.
• Leadership, negotiation and conflict management skills.