Senior Quality Assurance Lead — Aseptic & TPM Oversight

Katalyst-Healthcares-; Scottsdale (AZ); On-site; USD 130,000 - 170,000; Full time

Job summary

Katalyst-Healthcare is seeking a Senior Quality Assurance Manager to lead aseptic manufacturing operations and oversee quality for TPMs and client sites. You will drive compliance, audits, and product release decisions, ensuring timely, compliant, and cost-effective deliverables across multiple sites.

The role requires deep knowledge of aseptic processes, regulatory expectations, and strong leadership to coordinate cross-functional teams and elevate quality while balancing timelines and customer

Qualifications

• Bachelor's degree in life science or related field required.
• 7+ years total experience with at least 5 years in QA/aseptic manufacturing operations management.
• Knowledge of aseptic manufacturing and related pharma technologies.

Responsibilities

• Leads quality oversight across projects to deliver on-time, high-value QA outcomes.
• Drives quality/compliance for product transfers and organizational optimization.
• Supports TPM team in aseptic-event investigations with hands-on assessments.
• Implements aseptic best practices at TPM per Client standards and advances.
• Performs final quality release for products produced by TPMs.
• Recommends key quality, compliance and regulatory decisions.
• Ensures QA/tech agreements align with contracts and resolves gaps.
• Maintains relationships with TPMs and client plants to align quality responsibilities.
• Negotiates with external quality orgs to balance cost and quality.
• Coordinates QA audits, readiness plans, and corrective actions.
• Supports QA elements for new product launches with TPMs.
• Coordinates trend investigations and CAPA follow-ups.
• Conducts management reviews with TPMs to address issues.
• Reviews annual product quality reports from TPMs for trends.

Skills

Analytical skills

Problem solving

Interpersonal skills

Education

Bachelor's Degree in Life Science or related field

Job description

Katalyst-Healthcare is seeking a Senior Quality Assurance Manager to lead aseptic manufacturing operations and oversee quality for TPMs and client sites. You will drive compliance, audits, and product release decisions, ensuring timely, compliant, and cost-effective deliverables across multiple sites.

The role requires deep knowledge of aseptic processes, regulatory expectations, and strong leadership to coordinate cross-functional teams and elevate quality while balancing timelines and customer