Associate Director, Sterility Quality and Capital Projects

The Fountain Group. We are a national staffing firm and are currently seeking an Associate Director, Sterility Quality and Capital Projects for a prominent client. This position is REMOTE with Travel
.

Associate Director, Quality Capital Programs
Location: Remote (supporting new North Carolina sterile manufacturing campus)
Duration: 2-Year Contract Pay Rate: $70.00–$75.00/hour

We are seeking an experienced Associate Director, Quality Capital Programs to provide Quality Assurance leadership and oversight for major sterile manufacturing capital projects supporting the development of a new pharmaceutical manufacturing campus in North Carolina.

Reporting to the Director of Sterility Assurance & Contamination Control
, this individual will serve as the primary Quality representative for strategic capital programs, ensuring GMP, sterility assurance, and contamination control principles are incorporated throughout facility design, construction, commissioning, qualification, and operational readiness.

This highly collaborative leadership role partners with Engineering, Validation, Operations, Technical Services, Microbiology, and Quality organizations to ensure new manufacturing facilities, utilities, and equipment meet global regulatory and quality expectations.

• Provide Quality Assurance oversight throughout the design, commissioning, and qualification phases of sterile manufacturing capital projects.
• Serve as the primary Quality representative for large‑scale capital programs across the pharmaceutical manufacturing network.
• Lead GMP Design Reviews and Quality Risk Assessments to identify and mitigate contamination and compliance risks during facility design.
• Evaluate facility, utility, equipment, and process designs to ensure compliance with FDA, EMA, and global GMP requirements.
• Participate in System Risk Assessments (SRAs) and review commissioning, qualification, and validation documentation using risk‑based qualification principles.
• Assess critical quality attributes and critical design elements impacting product quality and regulatory compliance.
• Collaborate with Engineering, Operations, Validation, Microbiology, and cross‑functional project teams to ensure quality requirements are integrated throughout project execution.
• Support development and continuous improvement of Quality Systems, GMP Design Review templates, and Commissioning & Qualification procedures.
• Incorporate audit findings, inspection observations, and evolving regulatory expectations into capital project quality processes.
• Participate in Centers of Excellence (COEs) supporting Qualification & Validation and Facility/Utility/Equipment initiatives.
• Promote contamination control strategies and Quality Risk Management principles across capital programs.

• Bachelor's or Master's degree in Microbiology, Engineering, Biological Sciences, Pharmaceutical Sciences, or another relevant scientific discipline.
• Minimum 10 years of experience supporting sterile pharmaceutical manufacturing environments.
• Strong knowledge of aseptic manufacturing processes and QC Microbiology.
• Extensive experience with GMP regulations and contamination control principles supporting sterile manufacturing facilities.
• Experience supporting facility design, commissioning, qualification, validation, or capital expansion projects.
• Demonstrated expertise conducting GMP Design Reviews, Quality Risk Assessments, and contamination control evaluations.
• Thorough understanding of FDA, EMA, Annex 1, and global pharmaceutical regulatory requirements.
• Excellent organizational, leadership, and cross‑functional collaboration skills.
• Ability to manage multiple strategic initiatives in a fast‑paced, matrixed environment.

• Experience supporting greenfield manufacturing facilities or major pharmaceutical capital expansions.
• Knowledge of Commissioning & Qualification (C&Q) methodologies.
• Experience with Facility, Utility, and Equipment Qualification.
• Understanding of ISPE guidance, Quality Risk Management (ICH Q9), and contamination control strategies.
• Previous participation in global Quality or Validation Centers of Excellence.
• Experience supporting sterile biologics, injectable pharmaceuticals, vaccines, or advanced therapies.

Successful candidates typically come from pharmaceutical, biotechnology, biologics, or vaccine manufacturing organizations and possess experience in one or more of the following areas:

• Sterility Assurance
• Quality Assurance
• QC Microbiology
• Validation & Qualification
• Pharmaceutical Engineering
• Capital Project Quality
• Aseptic Manufacturing
• Commissioning & Qualification (C&Q)

This is an excellent opportunity to play a critical leadership role in the design and startup of a next‑generation sterile pharmaceutical manufacturing facility while influencing quality strategy across major capital investments.