Associate Director Of Quality Capital Programs

Responsibilities

• Provide quality oversight during the design phase and throughout commissioning and qualification activities for sterile manufacturing capital projects.
• Act as the primary quality representative on key capital projects, ensuring quality and GMP requirements are integrated into all phases of project execution.
• Apply knowledge of design principles and concepts relevant to sterile manufacturing processes to influence facility, utility, and equipment design.
• Lead GMP design review risk assessments for capital programs, ensuring contamination control and GMP requirements are thoroughly assessed and appropriately mitigated.
• Determine critical design elements that impact product quality and regulatory compliance, and evaluate the proposed test plans for qualifying facilities, utilities, and equipment.
• Standardize GMP design review templates for capital programs and integrate these standards into broader organizational practices.
• Contribute as a member of the Center of Excellence (COE) for Qualification and Validation to assess, support, and continuously improve commissioning and qualification processes and procedures for capital programs.
• Develop and implement processes that enable capital program teams to receive and act on feedback from audits, inspections, and regulatory updates, ensuring ongoing compliance of capital projects.
• Establish and maintain strong relationships with project team members across sites, engineering, central services, and other cross-functional groups, including teams focused on lab of the future and factory of the future initiatives, to achieve quality deliverables.
• Utilize expertise in quality risk management and contamination control strategies to support robust, compliant design and qualification approaches.
• Communicate effectively with stakeholders at all levels, providing clear, concise, and well-structured verbal and written updates on quality risks, mitigation plans, and project status.
• Anticipate potential quality and compliance issues, investigate root causes, and provide well-founded recommendations to support timely resolution.
• Manage multiple capital programs simultaneously, organizing priorities, resources, and timelines to create and sustain a high-performance work environment.

Requirements

• Bachelor’s or Master’s degree in Microbiology, a relevant science discipline, or an engineering-related field.
• Minimum 10 years of relevant experience with strong process knowledge of aseptic manufacturing and QC Microbiology.
• Comprehensive understanding of biological and pharmaceutical technologies relevant to sterile manufacturing.
• Strong quality assurance mindset with proven ability to apply GMP principles and contamination control strategies to capital projects.
• In-depth knowledge of pharmaceutical regulatory requirements and expectations related to contamination control and GMP design requirements.
• Knowledge of applicable pharmaceutical regulations and guidance, including the Code of Federal Regulations, EU GMPs, EMA and FDA guidelines, pharmacopeial standards, and PIC/S requirements.
• Experience with risk-based qualification approaches, including familiarity with ISPE Baseline Guide Volume 5: Commissioning and Qualification.
• Knowledge and practical experience in quality risk management principles, including ICH Q9.
• Ability to work strategically and align quality activities with broader organizational and project objectives.
• Excellent organizational skills with the ability to successfully manage multiple programs and competing priorities.
• Strong verbal and written communication skills, with the ability to convey complex quality and regulatory concepts clearly to diverse stakeholders.
• Ability to anticipate problems, identify and investigate issues, and develop sound recommendations to support resolution.
• Proficiency in project management practices related to capital programs in sterile manufacturing environments.

Essential Skills

• Experience leading GMP design review risk assessments for capital projects in sterile manufacturing.
• Proven ability to influence design decisions for facilities, utilities, and equipment to ensure compliance with contamination control and GMP requirements.
• Experience standardizing and implementing GMP design review templates or similar quality frameworks across multiple projects or sites.
• Participation in Centers of Excellence for Qualification and Validation or similar governance bodies focused on commissioning and qualification.
• Experience developing processes to capture and integrate feedback from audits, inspections, and regulatory changes into capital program practices.
• Demonstrated ability to collaborate effectively with cross-functional teams, including engineering, central services, and innovation-focused groups such as lab of the future and factory of the future initiatives.
• Track record of creating or contributing to a high-performance work environment through effective leadership, communication, and stakeholder engagement.
• Strong analytical and critical thinking skills applied to quality risk assessments, design reviews, and qualification strategies.
• Comfort working in a remote setting while maintaining strong communication and alignment with geographically dispersed teams.