QC Operations Lead – Digitization and Master Data
Pfizer
full-time
Posted on:
Location Type: Hybrid
Location: Lake Forest • Illinois • 🇺🇸 United States
Visit company websiteSalary
💰 $169,700 - $282,900 per year
Job Level
Senior
Tech Stack
SDLC
About the role
- 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
Benefits
- paid vacation
- holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
QC digital systemsmaster data managementprocess excellencedata mappingdata migrationenterprise system validationrisk managementcontinuous improvementGMP complianceSQA requirements
Soft skills
leadershipproject managementanalytical thinkingproblem solvingstrategic thinkingchange managementstakeholder engagementcommunicationinfluencingcoaching