ROLE SUMMARY

The Director, Quality Digital Team Lead is responsible for the development and implementation of digital innovation and electronic system strategies to assure high quality, effective, optimized and efficient Regulatory Quality Assurance (RQA) programs, and effective Quality & Risk Management across the enterprise. This includes business ownership of key systems that support quality objectives. This role provides oversight of technology infrastructure and system initiatives for all groups in RQA (GCP, PV, GLP, GMP, Inspection Management, Quality Management System and Operations) to ensure alignment between process, technology and culture. The Director, Digital ensures business excellence by driving process improvement, digital innovation, simplification, special projects and efforts focused on advancement of technology and seamless integration of RQA activities and results to the broader Pfizer Quality Management System.

This role acts as a partner to the RQA leadership team/ audit & inspection leads, Digital, and other quality groups in Pfizer.

ROLE RESPONSIBILITIES

Primary Responsibilities

• Provides leadership and ownership of all electronic systems and applications within RQA to ensure a cohesive and sustainable technology and data strategy across all groups internally and externally

• Manages team of quality professionals and contractors who are responsible for driving system strategies, quality/compliance objectives and continuous improvement

• Partners strategically with Data & Analytics leader to drive common, connected and robust infrastructure and digital roadmap to enable advanced user experience across integrated technologies in support of auditing

• Partners strategically with Business Process Owners and Operations to ensure alignment across people, process and technology advancements, including process user councils and program governance

• Serves as Quality leader across the enterprise for advancements in support of Quality Management System endeavors; leads and supports Systems governance in partnership with digital

• Formulates recommended strategies to maximize effectiveness, accuracy and efficiency of processes and systems

• Prioritizes investments in technology in conjunction with appropriate governance boards and Pfizer Digital; Accountable for the RQA Digital budget

• Provides subject matter expertise, thought leadership and vision in quality digital systems across multiple systems/sources to create actionable insights that drive execution of the enterprise Quality strategy

• Provides technical expertise to RQA and guides functional groups to ensure system requirements are identified, designed, and distributed appropriately to highlight and interpret issues, trends, and variances within the data

• Identifies and champions improvements to processes and technologies to help achieve RQA’s/Quality’s business objectives, promote efficiencies and productivity and to enhance partner satisfaction

• Ensures that technology and reporting tools are seamlessly integrated across business functions and implements training programs to allow colleagues to effectively utilize system reporting functionality

• Serves as technology SME on various committees, with respect to Processes and Systems, including Vox/GenAI

• Provides updates and training on trends and issues related to business processes and support technologies to the RQA LT and colleagues

• Collaborates with Pfizer Digital to identify business requirements and implements systems solutions that streamline and/or re-engineer processes and automate operations

• Strategically partners with Digital to ensure proper data excellence, quality and governance for all systems leveraged for quality objectives

• Monitors emerging technologies and industry trends to inform the development of novel analytic solutions and positioning Pfizer as industry leader

• Accountable for ensuring validation / controls in place to support digital and data science capabilities

• Represents Pfizer externally as applicable

People Management

• Provides management to appropriately qualified/skilled digital audit, data science and technology professionals to meet the technology and operational needs of RQA and to optimize skill utilization across a matrix organization

• Determines colleague skills and drives the global integrated talent pool in alignment with the RQA strategy and audit process, as appropriate

• Responsible for staff talent development, career development and performance management

• Provides current and strategic direction, as well as complete, actionable, positive and corrective feedback to others

• Assigns clear responsibility for tasks and decisions, empowers the team to independently execute on responsibilities and find solutions, sets clear objectives and measures, monitors process/progress/results, and designs feedback loops into work

QUALIFICATIONS

MUST-HAVE:

• Bachelor’s degree or equivalent required

• 10+ years of relevant experience

• Experience in Quality Systems and GxP

• Expertise in digital technologies, applications and digital architecture

• Experience leading cross-functional teams to plan and implement processes and systems to optimize business operations

• Global perspective within the context of business needs and impact

• Demonstrated business acumen in applying technology to support and improve business processes

• System fluency on relevant Pfizer information systems utilized by RQA

• Expertise in data science, analytics and reporting applications

• Proven accountability and demonstrated excellent interpersonal, communication, negotiation, influencing, presentation development and problem-solving capabilities

• Proven project management capability and ability to execute against timelines

• Experience evaluating and understanding quality standards or their application

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

NICE-TO-HAVE:

• Advanced degree in technology area strongly preferred

• Qualification in Project Management or equivalent, a plus

• Continuous improvement expertise, a plus

Work Location Assignment:Flexible

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