Vice President Central Quality Operations
United States - New Jersey - Parsippany, United States - California - Foster CityQualityRegularDescrizione del lavoro
The Vice President of Central Quality Operations will lead and influence Quality strategy for Gilead Global Quality Management System (QMS) and the design, implementation and delivery of systems and execution for GMP/GDP (Good Manufacturing and Distribution Practices) activities in the Global Markets organizations across every country in the world. Ensure the enterprise wide QMS structure, policy, standards and systems are fit for purpose across PDM, Commercial and other functional areas for the current and future direction of Gilead business needs, industry trends and regulations.. The role provides a significant impact across many areas as the QMS and Global Market GMP/GDP activities are core to Gilead’s License to Operate and ability to supply products in all markets.
This is a critical and most senior quality leadership role in managing Gilead’s GMP/GDP Quality Systems as a key member of the Quality Leadership team. The role holder will assess the strategic and tactical requirements for the delivery of Quality performance across business areas, aligning with the strategic priorities of Gilead. The incumbent will act as the independent arbiter of the Quality Management system with responsibilities and impact across all activities and decisions taken concerning the quality and compliance aspects of manufacturing and supply.
The Vice President of Central Quality Operations has a key role in protecting Gilead’s reputation and license to operate globally. They will ensure the development of the quality capability and quality compliance understanding globally, both for staff in Quality and generally in the manufacturing and supply organizations.
In addition, the Vice President of Central Quality Operations will be responsible for the implementation of Proactive Quality through the development of Human and Organizational Performance processes and drive the creation of a Modern Quality Professional to enhance the Quality capabilities not only of Quality but for the whole of PDM.
The Vice President of Central Quality Operations serves as a key strategic partner responsible for the following quality functions: Quality Systems, Complaints, Product Quality Leaders, Device Quality, Annual Product Quality Report (APQR), IT Quality and Issue Management examples as follows:
Quality Systems
Responsible for developing, implementing, and overseeing a comprehensive quality management system across an organization, ensuring compliance with industry standards and regulations, driving continuous improvement initiatives, and leading the quality function to maintain high product and service quality across all operations; this role involves strategic planning, regulatory oversight and collaboration with cross-functional teams to identify and address quality issues
Complaints
Responsible for overseeing a team that is managing and resolving customer complaints, ensuring all investigations and responses adhere to established quality standards and regulatory requirements, while identifying root causes and implementing corrective actions to prevent future issues, often collaborating with cross-functional teams to drive continuous improvement within the organization.
APQR
Responsible for overseeing a team that owns the entire process of compiling and presenting a comprehensive annual report detailing the quality performance of a company's products, including data analysis, trend identification, corrective action planning, and communication of findings to key stakeholders, essentially acting as the lead quality expert in ensuring the report accurately reflects the product quality landscape across the organization.
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)