Manufacturing Quality Assurance Manager

Agilent Technologies; Texas; On-site; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking a Manufacturing Quality Assurance (MQA) Manager to oversee quality activities at the Cedar Creek site. You will lead and develop a QA team, ensure inspection readiness, and support audits while managing deviations, investigations, CAPA, and change controls to sustain compliant manufacturing operations.

The role emphasizes continuous improvement, validation oversight, and effective communication of quality metrics to stakeholders across the site.

Qualifications

• Bachelor’s degree in Science, Engineering, or related field.
• 8+ years of regulated manufacturing quality experience (medical device, pharma, biotech).
• 3+ years in leadership roles.
• Strong knowledge of FDA, ISO 13485, cGMP, and QMS.

Responsibilities

• Lead and develop a QA team and ensure inspection readiness.
• Support audits and provide quality oversight for manufacturing operations.
• Oversee quality systems (deviations, investigations, CAPA, change controls).
• Drive continuous improvement, validation oversight, and communicate quality metrics.

Skills

Leadership

Problem-solving

Risk assessment

Data analysis

Education

Bachelor’s degree in Science, Engineering, or related field

Job description

Role: Manufacturing Quality Assurance (MQA) Manager overseeing quality activities at the Cedar Creek site, ensuring compliance with regulatory standards and internal policies. Responsibilities include leading and developing a QA team, maintaining inspection readiness, supporting audits, overseeing quality systems (deviations, investigations, CAPA, change controls), and providing quality oversight for manufacturing operations. The role emphasises continuous improvement, validation oversight, and effective communication of quality metrics.

Requirements:

• Bachelor's degree in Science, Engineering, or related field
• 8+ years of regulated manufacturing quality experience (medical device, pharma, biotech)
• 3+ years in leadership roles
• strong knowledge of FDA, ISO 13485, cGMP, and QMS

Preferred skills:

• Preferred skills encompass leadership, problem-solving, risk assessment, and data analysis capabilities; experience in medical device manufacturing and supporting regulatory audits preferred.

High-Value: regulated biotech/pharma manufacturing, quality systems, compliance with FDA/ISO, quality metrics, continuous improvement initiatives.

Work setup: full-time, day shift, occasional travel, remote or onsite.