Associate Director, Sterile Quality - Capital Programs

US Tech Solutions; North Carolina; On-site; USD 150,000 - 210,000; Full time

Job summary

US Tech Solutions is seeking an Associate Director of Quality for Capital Programs to provide quality assurance oversight across sterile manufacturing capital projects from early design through Commissioning and Qualification, ensuring GMP and contamination control requirements are met.

The role requires extensive experience in aseptic manufacturing, regulatory knowledge, and leadership within cross-functional teams to drive risk-based qualification and enhance the quality system supporting

Qualifications

• Minimum 10 years relevant experience with process knowledge of aseptic manufacturing and QC Microbiology.
• Strong quality assurance mindset with knowledge and experience in either; quality assurance, engineering, operations, or technical area with a comprehensive understanding of biological and pharmaceutical technologies.
• Knowledge of pharmaceutical regulatory requirements and expectations supporting contamination control and GMP design requirements.
• Knowledge of Regulatory Requirements including CFR, EU GMPs, EMA/FDA Guidelines, Pharmacopeia, PIC/S.
• Knowledge and experience with risk-based qualification (ISPE Baseline Guide Volume 5) and quality risk management (ICH Q9).
• Ability to work strategically, excellent organizational skills and the ability to manage multiple programs and create a high-performance work environment.
• Excellent communication skills are required, both verbally and written.
• Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve.

Responsibilities

• Quality oversight at design phase and commissioning and qualification of sterile manufacturing capital programs.
• Knowledge of design principles for Sterile Manufacturing.
• Lead GMP Design Review Risk assessments for capital programs.
• Influences the Quality aspects of capital programs with regulatory knowledge.
• Drives GMP and quality requirements for facility, utility and equipment designs.
• Participate in system risk assessments and review of qualification documents.
• Determine critical design elements impacting product quality and regulatory compliance.
• Standardize GMP design review templates and integrate into the Client’s Quality System.
• Assess and continuously improve the Quality System supporting Capital Programs, Commissioning and Qualification.
• Develop processes to receive audit feedback and regulatory updates.
• Collaborate with site project teams and cross-functional groups to achieve quality deliverables.
• Knowledge of FDA, EMEA regulatory scope.
• Knowledge of Quality Risk Management and contamination control strategies.
• Member of Centers of Excellence.

Skills

Excellent communication

Strategic thinking

Organizational skills

Problem solving

Cross-functional collaboration

Quality assurance mindset

Regulatory knowledge

Risk management knowledge

Aseptic manufacturing knowledge

Education

Bachelor/Master in Microbiology

Job description

US Tech Solutions is seeking an Associate Director of Quality for Capital Programs to provide quality assurance oversight across sterile manufacturing capital projects from early design through Commissioning and Qualification, ensuring GMP and contamination control requirements are met.

The role requires extensive experience in aseptic manufacturing, regulatory knowledge, and leadership within cross-functional teams to drive risk-based qualification and enhance the quality system supporting