QC Operations Digitization and Master Data Technical Lead

Pfizer•Lake Forest, CA

2d•Hybrid

About The Position

The IMOQ QC Operations Digitization and Master Data Technical Lead is responsible for driving the digital enablement, optimization and standardization of QC business and operational processes across the IMOQ network of QC laboratories as part of the execution of the PGS QC Lab Strategy. The role will focus on the selection, design, governance, implementation, maintenance and continuous improvement of QC digital solutions. This will be achieved through driving process excellence in master data requirements, management and technical support as well as ensuring data integrity, system efficiency, and compliance across enterprise platforms. The Lead will develop measurements and metrics to drive QC digital performance while enhancing operational efficiency and cost-effectiveness. The Lead will provide leadership to the core QSEO technical SMEs that support global master data creation and maintenance as well as IMOQ site master data teams. The Lead will partner with the Digital QC Solutions lead, QC Digital Client Partner/ Technical team, QSEO BSOs/GPOs/LPOs, Computer System Strategy & Validation team, QSEO Data and Analytics Lead, QC Operations Leads, SQOLs, QO Cluster leads as well as Procurement, external vendors/service providers and other stakeholders to deliver the QC Operations strategic initiatives. The lead will work closely with the PGS QC Lab Strategy team to achieve the overall QC Lab strategies. This position will report to the VP, QSEO QC Operations Lead What You Will Achieve Lead QC digital systems/solutions selection, design, implementation and governance, as well as upgrades, in partnership with Digital teams, ensuring master data requirements, structure, standardization, and ease of maintenance are integral to selection and deployment as well as timely site uptake. Develop and implement process excellence in QC master data requirements, management and technical support to optimize QC resource utilization, reduce cycle times and ensure supply reliability. Oversee QC master data in systems such as LIMS, Empower, NuGenesis, SAP QM, SDS, LMO and related platforms, including creation and change of global (shared) master data, troubleshooting of master data issues while also ensuring timely completion and accuracy. Oversee master data verification & provide Quality oversight for GMP /GDP Digital systems as necessary, ensuring compliance with Pfizer CSA/SDLC requirements, 21 CFR Part 11, Eudralex Vol 4 Annex 11 & associated global regulations. Conduct periodic master data quality audits, identify discrepancies and lead corrective and preventive actions. Identify, assess and recommend master data technologies (e.g. Master Data Management tools, AI enabled data creation) and other process excellence tools to streamline and implement opportunities for workflow optimization, enhance productivity that enable improved QC process efficiency and transparency, while maintaining relevant quality and compliance standards. Build QC process excellence capabilities across the network through leading and coaching of core SME and IMOQ site master data teams and sharing best practices. Facilitate knowledge sharing between sites and functions. Define and track master data quality KPIs and dashboards including accuracy, completeness, cycle time and consistency across all systems and sites. Oversee contracted 3rd party master data support spend, establish governance and performance monitoring to ensure value realization, cost effectiveness and performance of external partners. Build strong and enduring partnerships with Digital teams and all network and site QSEO stakeholders to drive joint digital strategies and ensure successful adoption of new processes. Lead and manage effective strategic QC network change initiatives to ensure successful adoption of new processes and ways of working

Requirements

Bachelor's Degree and minimum 10+ years’ experience working in QO digital solutions delivery
Proven leadership skills and ability to work across functions with all levels of the organization where the incumbent may not have direct authority.
Demonstrated skills in analyzing, organizing, and project management across several cultures.
Demonstrated change agility to successfully manage a high degree of complexity and multiple priorities.
Expertise in QC / QO Operations enterprise system selection, design and deployment, including master data mapping, migration, and master data development, validation, risk management and continuous improvement.
Proven track record in successfully leading transformation of QO digital platforms/ solutions including standardization and harmonization initiatives across multiple sites regionally and globally
Expertise in enterprise system validation/SQA requirements and strong knowledge of Pfizer Digital life cycle methodologies (S/ADLC) including risk-based approaches (e.g., CSA, GAMP5, QRM)
Strong analytical thinking, problem solving and decision making as well as strategic thinking
Strong leadership skills including communication and influencing skills (able to work across levels and functions)
Excellent change management and stakeholder engagement skills & project management skills
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.
Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets
Primarily standard work hours with some exceptions to meet business needs.
Some travel will be required to support network and site initiatives; ~10% required travel.
This position requires permanent work authorization in the United States.

Responsibilities

Lead QC digital systems/solutions selection, design, implementation and governance, as well as upgrades, in partnership with Digital teams, ensuring master data requirements, structure, standardization, and ease of maintenance are integral to selection and deployment as well as timely site uptake.
Develop and implement process excellence in QC master data requirements, management and technical support to optimize QC resource utilization, reduce cycle times and ensure supply reliability.
Oversee QC master data in systems such as LIMS, Empower, NuGenesis, SAP QM, SDS, LMO and related platforms, including creation and change of global (shared) master data, troubleshooting of master data issues while also ensuring timely completion and accuracy.
Oversee master data verification & provide Quality oversight for GMP /GDP Digital systems as necessary, ensuring compliance with Pfizer CSA/SDLC requirements, 21 CFR Part 11, Eudralex Vol 4 Annex 11 & associated global regulations.
Conduct periodic master data quality audits, identify discrepancies and lead corrective and preventive actions.
Identify, assess and recommend master data technologies (e.g. Master Data Management tools, AI enabled data creation) and other process excellence tools to streamline and implement opportunities for workflow optimization, enhance productivity that enable improved QC process efficiency and transparency, while maintaining relevant quality and compliance standards.
Build QC process excellence capabilities across the network through leading and coaching of core SME and IMOQ site master data teams and sharing best practices.
Facilitate knowledge sharing between sites and functions.
Define and track master data quality KPIs and dashboards including accuracy, completeness, cycle time and consistency across all systems and sites.
Oversee contracted 3rd party master data support spend, establish governance and performance monitoring to ensure value realization, cost effectiveness and performance of external partners.
Build strong and enduring partnerships with Digital teams and all network and site QSEO stakeholders to drive joint digital strategies and ensure successful adoption of new processes.
Lead and manage effective strategic QC network change initiatives to ensure successful adoption of new processes and ways of working

Benefits

participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage

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