Vice President Central Quality Operations

Issue Management 

Responsible for overseeing the identification, analysis and resolution of quality issues across an organization, ensuring compliance with industry standards and regulations, driving continuous improvement initiatives, and leading a team to proactively prevent future quality problems by developing robust quality management systems and processes.   

Product Quality Leaders 

PQLs are the main contact for product teams from a Quality perspective. Highly skilled in a wide range of areas (specifications, comparability, methods, product and process attributes, stability etc.) the PQLs use science and risk knowledge to focus on product quality and product development from a quality perspective. 

Device Quality 

Device Quality is similar to the PQLs in that they are exerts in the development and management of Devices and Combination products from a Quality perspective.  They are the main quality contact for development and device teams and provide quality, science and risk-based oversight over the development, licensure and maintenance of devices and combination products, ensuring we maintain our license to operate. 

Requirements: 

• Ability to quickly establish credibility with diverse audiences and be perceived as a leader. 

• Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills. 

• Ability to drive continuous improvement and productivity efforts with the Quality Systems and ensure their simplification and digitalization. 

• Strong understand the manufacturing of both small and large molecules, particularly sterile manufacturing and associated requirements.  

• Significant in-depth understanding of business objectives and how they translate into quality priorities. 

• Must have the experience and confidence necessary to work with senior executives, and the ability to build rapport with employees at all levels. 

• Competent in both strategy and execution. 

• Expertise and track record in managing quality in a large, global pharma company. 

• Expert people and project management skills. 

• Possesses in-depth knowledge of industry best practices across all modalities. 

• Experienced understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP) and solid knowledge of worldwide regulatory requirements. 

• Strong working knowledge of relevant regulatory guidance, including pharmaceutical GMPs (Good Manufacturing Practices) and ICH (International Council for Harmonization) guidance. 

• Experience establishing and/or enhancing development and commercial GxP quality infrastructure and systems compliant with U.S. and international requirements and a successful record of accomplishment managing U.S. and international pre- and post- approval inspections. 

• Knowledge of quality risk assessment and management methodologies, including successful application and risk remediation. 

• Prior success in working effectively with senior scientific and operations staff. 

• Ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness, and where precedent may not exist. 

• Deep understanding of Human and Organizational Performance processes and strategies 

• Ability to show transformational change and productivity desired. 

Qualifications: 

• 20+ years of experience and a BS, or degree in related fields. 

• Extensive knowledge and experience in quality in highly regulated manufacturing environments is required. 

• Experience managing People Managers. 

• Experience in biotech or pharmaceuticals industry required. 

• Experience as a Quality Site Head strongly preferred. 

People Leader Accountabilities 

• Create Inclusion - knowing the business value of diverse teams, modelling 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, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. 

Gilead Core Values 

• Integrity (Doing What’s Right) 

• Inclusion (Encouraging Diversity) 

• Teamwork (Working Together) 

• Excellence (Being Your Best) 

• Accountability (Taking Personal Responsibility)