Director, Quality Operations

Kindeva Drug Delivery Company; Missouri; On-site; USD 120,000 - 160,000; Full time

Job summary

A pharmaceutical company is seeking a Director of QA Operations to lead quality assurance at a sterile fill-finish manufacturing facility in Missouri. The ideal candidate will have over 10 years of progressive experience in Quality Assurance within pharmaceutical manufacturing, with a strong focus on compliance with global regulations and leading high-performing teams. The role involves ensuring the timely release of drug products and overseeing QA processes to maintain inspection readiness.

Qualifications

• 10+ years of experience in pharmaceutical Quality Assurance, with 5+ years in a leadership role.
• In-depth knowledge of cGMP regulations.
• Proven leadership in QA operations for sterile drug products.

Responsibilities

• Lead QA Operations and ensure compliance with FDA and EMA regulations.
• Oversee timely release of sterile drug product batches.
• Develop robust QA processes aligned with corporate QMS.

Skills

Leadership in QA operations

Knowledge of cGMP regulations

Problem-solving skills

Interpersonal and communication skills

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Tools

Electronic QMS

Job description

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.