Director, Facilities & Equipment Quality Strategy, and Technical Oversight Support

Job Description

We are seeking a Director for a Facilities & Equipment Quality Oversight Support role. The role is a critical leadership role responsible for establishing, implementing, and maintaining global quality standards and processes for all company facilities and equipment. Serving as the primary point of contact and decision-maker for internal policies, procedures, and strategy documents governing the quality of facilities and equipment across the global network, this role will ensure robust and compliant infrastructure and assets. The Director will support knowledge advancement across the organization, drive process improvements and harmonization, represent the company in relevant industry forums, and partner with global quality functions to ensure consistent and high-quality standards.

Strategic Quality Oversight of Facilities and Equipment:

• Serve as the primary global point of contact and decision-maker for internal policies, procedures, and strategies governing facilities and equipment quality oversight.

• Provide strategic quality oversight for the design, installation, commissioning, qualification, and validation of facilities, equipment, and utilities, leveraging engineering standards, Quality by Design principles, and experience aligned with FDA, ICH, & ISPE guidelines.

• Ensure all activities comply with current Good Manufacturing Practices (cGMPs), company policies, and regulatory requirements.

• Sponsor and oversee process improvements and harmonization projects across the network for facilities and equipment quality.

• Ensure robust and consistent control strategies for facilities and equipment are maintained for valuation and continuous improvement, meeting regulatory and compliance expectations.

• Serve as the SME leader for facilities and equipment quality across the network, representing on relevant teams and governance forums.

• Provide technical support during new process design and facility start-up to ensure site facilities and equipment quality programs and product requirements are met.

• Provide technical support for investigations related to facilities and equipment quality to identify root causes and implement corrective actions, sharing best practices/learnings/CAPAs across the network.

• Support regulatory submissions and on-site inspections related to facilities and equipment; define and execute the process for managing network observations and commitments.

Technical Knowledge:

• Demonstrate in-depth understanding and application of GMP principles, concepts, best practices, and standards (US and international) specific to facilities and equipment.

• Ability to develop and improve complex concepts, techniques, standards, and new applications for facilities and equipment based on quality principles.

• Ability to develop innovative solutions to complex facilities and equipment quality problems where precedents may not exist.

• Proficiency in data analysis of facility and equipment performance, prioritization, attention to detail, critical decision-making, and complex problem-solving.

• Demonstrate extensive knowledge of industry best practices and trends in facilities and equipment quality and reliability.

• Experience building effective working relationships across all internal and external stakeholders impacting facilities and equipment quality.

• Demonstrate excellent verbal, written, and interpersonal communication skills.

• Comfortable interacting with regulatory agencies on facilities and equipment topics.

Cross-Functional Collaboration:

• Partner with Global Quality to support the development, implementation, and oversight of facilities and equipment quality programs.

• Ensure local and global quality decisions related to facilities and equipment are applicable, documented, and traceable to company processes.

• Support knowledge advancement beyond Quality to build and maintain capabilities across the network for facilities and equipment quality; develop knowledge-based programs and mentor stakeholder SMEs.

• Collaborate globally with engineering, facilities, manufacturing, and other departments to ensure quality requirements are met and business objectives achieved.

• Communicate effectively with senior management and stakeholders at all levels.

• Provide leadership, guidance, and support to team members, fostering a culture of quality and compliance.

Basic Qualifications:

• PhD with 8+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR

• Master’s degree with 10+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR

• Bachelor’s degree with 12+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR

• Associate’s degree with 14+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR

• High School Degree with 16+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment.

Preferred Qualifications:

• Demonstrated understanding and relevant experience of scientific and engineering principles for the design, maintenance, and quality oversight of facilities and equipment in a regulated manufacturing environment.

• Experience in validation of facilities, utilities, and equipment.

• Significant experience leading global teams and/or projects/initiatives related to facilities and equipment quality.

• Experience with reliability engineering principles applied to pharmaceutical or similar manufacturing equipment.

• Experience with cell and gene therapy manufacturing and associated facility and equipment requirements.

• In-depth knowledge of specific regulations for cell and gene therapy facilities and equipment.

• Certification in a relevant area (e.g., CQE, CQA).