Job Description

Director of Quality & Regulatory - cGMP Aseptic Processing

Location - Fort Worth, Texas

Mason Harding is excited to be supporting a successful m anufacturer of sterile packaging, delivery devices and biological reagents , mainly serving pharmaceutical and clinical sectors with custom development and manufacturing solutions too.

Due to the expansion of their aseptic processing and sterile solutions , we’re looking to appoint a newly created Director of Quality & Regulatory expert at their Fort Worth cGMP and FDA registered site.

Main duties and responsibilities include: -

Quality Strategy and Leadership:

• Develop and implement a comprehensive quality management strategy aligned with organizational goals.
• Lead and mentor a team of quality professionals to achieve high standards of product/service quality.
• Ensure adherence to quality standards, certifications (e.g., ISO, Six Sigma ), and regulatory requirements (e.g., FDA, GMP ).

Quality Control and Assurance:

• Ensure compliance with cleanroom operations, aseptic processing , and appropriate gowning/ contamination control.
• Oversee quality control processes, including inspections, audits, and testing protocols.
• Conduct risk assessments, develop risk control plans, and ensure compliance with data integrity and part 11 requirements.

Regulatory Compliance and Risk Management:

• Ensure that products and services meet all applicable regulatory and compliance standards (e.g., ISO 9001, FDA, ISO 13485, ISO 14644 , industry-specific regulations).
• Perform regulatory submissions and registrations (e.g. 510k submissions , annual reporting, site registration)
• Identify and assess potential risks to product quality and develop mitigation plans.
• Lead internal and external audits and regulatory inspections, ensuring compliance with all relevant regulations.

Training and Development:

• Provide training and development for employees on quality management principles, processes, and best practices with a quality-centric approach.

Key requirements for the role: -

• Bachelor’s degree in engineering, Quality Management, Business Administration, or a related field (master’s degree preferred).
• 10+ years of experience in quality system management , with ideally at least 5 years spent in a leadership role .Experience in a regulated industry (e.g. medical device manufacturing, pharmaceuticals, chemicals) with aseptic processing experience highly desired.
• Six Sigma Black Belt, ISO 9001 Lead Auditor, or similar quality-related certifications.
• A strategic leader able to work cross-functionally with a focus on continuous improvement.

This is a unique leadership opportunity for any Quality leader from a highly regulated sector, looking to make a true impact with an all-star team, with clear routes for progression!

Keywords : aseptic fill, aseptic processing, FDA, cGMP, ISO 9001, ISO 14644, ISO 13485 , 510k submissions, quality assurance, quality control, regulatory affairs, leadership, pharmaceutical manufacturing, biotechnology,

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