Kindeva Drug Delivery Company
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make
The Director of QA Operations is responsible for leading and managing the Quality Assurance operations function at a sterile fill-finish manufacturing facility. This role ensures the site’s compliance with global cGMP regulations, internal quality standards, and customer requirements. The Director will provide strategic direction, oversight of QA operations teams, and serve as a key member of the site leadership team, supporting both clinical and commercial manufacturing. Role Responsibilities
Provide leadership and direction for QA Operations, including batch record review, shop floor quality oversight, line clearance, and deviation/investigation support. Ensure timely release of sterile drug product batches in compliance with FDA, EMA, and other global health authority regulations. Develop, implement, and maintain robust QA processes aligned with corporate Quality Management System (QMS). Oversee management and resolution of deviations, CAPAs, and change controls related to QA operations. Partner with Manufacturing, QC, Engineering, and Supply Chain to support operational excellence and continuous improvement initiatives. Ensure QA operations team maintains inspection readiness at all times; serve as SME during regulatory and customer audits. Provide oversight and guidance for training, mentoring, and development of QA staff to build a strong quality culture. Drive continuous improvement in contamination control, aseptic practices, and data integrity compliance. Support technology transfers, new product introductions, and validation activities from a QA operations perspective. Establish, monitor, and report key performance indicators (KPIs) for QA operations to site and executive leadership. Basic Qualifications
Bachelor’s degree in Life Sciences, Engineering, or related field required. 10+ years of progressive experience in pharmaceutical Quality Assurance, with 5+ years in a leadership role within sterile manufacturing. In-depth knowledge of cGMP regulations (21 CFR Parts 210, 211, 11; EU Annex 1; ICH guidelines). Proven leadership in QA operations for sterile drug product (aseptic processing, pre-filled syringes, vials, etc.). Strong track record of success during regulatory inspections (FDA, EMA, MHRA, etc.). Demonstrated ability to build, lead, and inspire high-performing teams. Excellent problem-solving, risk assessment, and decision-making skills. Strong interpersonal and communication skills, with the ability to influence cross-functional teams and executive leadership. Preferred Qualifications
Advanced degree (M.S., Ph.D., or MBA). Experience with electronic QMS, EBR, and data integrity systems.
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At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make
The Director of QA Operations is responsible for leading and managing the Quality Assurance operations function at a sterile fill-finish manufacturing facility. This role ensures the site’s compliance with global cGMP regulations, internal quality standards, and customer requirements. The Director will provide strategic direction, oversight of QA operations teams, and serve as a key member of the site leadership team, supporting both clinical and commercial manufacturing. Role Responsibilities
Provide leadership and direction for QA Operations, including batch record review, shop floor quality oversight, line clearance, and deviation/investigation support. Ensure timely release of sterile drug product batches in compliance with FDA, EMA, and other global health authority regulations. Develop, implement, and maintain robust QA processes aligned with corporate Quality Management System (QMS). Oversee management and resolution of deviations, CAPAs, and change controls related to QA operations. Partner with Manufacturing, QC, Engineering, and Supply Chain to support operational excellence and continuous improvement initiatives. Ensure QA operations team maintains inspection readiness at all times; serve as SME during regulatory and customer audits. Provide oversight and guidance for training, mentoring, and development of QA staff to build a strong quality culture. Drive continuous improvement in contamination control, aseptic practices, and data integrity compliance. Support technology transfers, new product introductions, and validation activities from a QA operations perspective. Establish, monitor, and report key performance indicators (KPIs) for QA operations to site and executive leadership. Basic Qualifications
Bachelor’s degree in Life Sciences, Engineering, or related field required. 10+ years of progressive experience in pharmaceutical Quality Assurance, with 5+ years in a leadership role within sterile manufacturing. In-depth knowledge of cGMP regulations (21 CFR Parts 210, 211, 11; EU Annex 1; ICH guidelines). Proven leadership in QA operations for sterile drug product (aseptic processing, pre-filled syringes, vials, etc.). Strong track record of success during regulatory inspections (FDA, EMA, MHRA, etc.). Demonstrated ability to build, lead, and inspire high-performing teams. Excellent problem-solving, risk assessment, and decision-making skills. Strong interpersonal and communication skills, with the ability to influence cross-functional teams and executive leadership. Preferred Qualifications
Advanced degree (M.S., Ph.D., or MBA). Experience with electronic QMS, EBR, and data integrity systems.
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