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

Gilead Sciences•Santa Monica, CA

48d•$191,250 - $247,500

About The Position

The Director, Facilities and Equipment Quality Strategy and Technical Oversight, provides global Quality leadership for GMP facilities, utilities, and equipment across the company network. In collaboration with Facilities and Engineering, this role supports the definition of enterprise policies, standards, and strategies that ensure infrastructure and assets remain compliant, reliable, and fit for intended use throughout their lifecycle. The Director provides independent Quality oversight and approval, guides risk-based decisions, advances organizational capability, drives harmonization and continuous improvement, and partners with site and global functions to deliver consistent quality and regulatory outcomes.

Requirements

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.

Nice To Haves

Demonstrated knowledge and application of scientific, engineering, and Quality principles across the lifecycle of facilities, utilities, and equipment in a regulated manufacturing environment.
Experience providing Quality oversight for the commissioning, qualification, and validation of facilities, utilities, and equipment.
Experience leading global, cross-functional teams, programs, or initiatives involving facilities, utilities, and equipment quality.
Experience applying reliability engineering and risk-based principles to pharmaceutical or similar manufacturing assets.
Experience with cell and gene therapy manufacturing and associated facilities, utilities, and equipment requirements.
In-depth knowledge of regulations and industry expectations applicable to cell and gene therapy facilities, utilities, and equipment.
Relevant professional certification, such as CQE or CQA.

Responsibilities

Collaborate with Facilities and Engineering to define and maintain enterprise policies, standards, and strategies; provide independent Quality review and approval.
Provide Quality oversight and approval across the facilities, utilities, and equipment lifecycle, applying engineering standards, Quality by Design principles, and relevant FDA, ICH, and ISPE guidance.
Ensure compliance with cGMPs, company policies, and regulatory requirements through risk-based oversight, escalation, and approval.
Lead network-wide harmonization and continuous improvement to strengthen governance, consistency, compliance, and reliability.
Ensure control strategies are established, maintained, periodically evaluated, and continuously improved.
Serve as the global Quality subject matter expert, representing Quality in governance forums and guiding risk-based decisions.
Provide Quality oversight and approval for new process design and facility start-up.
Oversee significant investigations, corrective and preventive actions, and the sharing of lessons learned across the network.
Provide Quality oversight and approval for regulatory submissions and inspections and govern related observations and commitments through closure.
Apply in-depth knowledge of U.S. and international GMP requirements, standards, and best practices for facilities, utilities, and equipment.
Translate Quality and engineering principles into effective policies, standards, strategies, and lifecycle controls.
Develop risk-based solutions to complex facilities, utilities, and equipment quality issues where precedents may be limited.
Analyze performance and reliability data to prioritize risks, guide decisions, and support continuous improvement.
Maintain current knowledge of industry practices, emerging technologies, and regulatory trends affecting facilities and equipment quality and reliability.
Build effective partnerships with Facilities, Engineering, Quality, Manufacturing, suppliers, and other internal and external stakeholders.
Communicate complex technical and Quality matters clearly to technical, business, and executive audiences.
Represent Quality effectively in regulatory interactions involving facilities, utilities, and equipment.
Partner with Global Quality, Facilities, and Engineering to define, implement, and maintain facilities, utilities, and equipment quality programs.
Ensure local and global Quality decisions are risk-based, documented, traceable, and aligned with company processes.
Build network capability through knowledge programs, communities of practice, and mentoring stakeholder subject matter experts.
Collaborate across Engineering, Facilities, Manufacturing, and other functions to meet quality requirements and business objectives.
Communicate decisions, risks, and recommendations clearly to senior leaders and stakeholders at all levels.
Provide leadership and guidance that reinforces a culture of quality, compliance, accountability, and continuous improvement.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.