Site Data Integrity Manager (Secondment / 12-18 Months)

Pfizer•Kalamazoo, MI

1d•Hybrid

About The Position

Experienced data integrity professional responsible for the development, delivery, assessment and maintenance of the Site Data Integrity program. Works effectively as a member of the Quality Compliance & Systems team, as well as with other site individual contributors, Management, Leadership, and Corporate SMEs to support Data Integrity initiatives.

Requirements

Applicant must have a bachelor's degree with at least 5 years of experience; OR a master's degree with at least 3 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
Substantial experience in pharmaceutical manufacturing and quality control
Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects
Knowledge of regulations related to vendor management programs and other industry quality systems
Strong critical thinking skills and a proactive approach
Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally
Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms
Candidate is required to have a sound understanding of GMPs and various types of validation and data integrity documentation (e.g. SOPs, User Guides, IQ/OQ, risk assessment)
Strong organizational and prioritization skills to handle multiple items with changing deadlines
Strong critical thinking and analytical skills with high attention to detail
Ability to manage change and deal with ambiguity
Proficiency with Microsoft Outlook, Excel, PowerPoint
Demonstrated track record with deviation investigations & CAPA development
Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
Knowledge or exposure to data science
Strong leadership and team management skills
Ability to work under pressure and meet tight deadlines
Ability to influence and negotiate with stakeholders
Experience in conducting internal audits and supporting regulatory inspections
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Candidates must be authorized to be employed in the U.S. by any employer.
This position requires permanent work authorization in the United States.

Nice To Haves

Demonstrated use of Data Integrity principles and concepts
Demonstrated presentation skills to customers at various levels, with good written and verbal communication skills

Responsibilities

Working with the Kalamazoo Leadership Team and QOLT to provide leadership for good data management practices, processes, communications and culture for GMP activities
Establishing data management governance processes and leading projects to ensure conformance to DI-related GSOPs and GWIs
Engaging Corporate DI subject matter experts as needed
Reporting good data management challenges and requirements to site leadership
Ensuring referable compliance issues related to DI are reported to Corporate Compliance
Participating in site inspection readiness activities
Ensuring site Training Curricula include training for good data management practices
Engaging in network forums for good data management, including sharing of best practices, challenges and solution-based ideas
Deliver / Facilitate training directly related to data integrity as needed
Conduct and assist with Internal Walkthrough Audits in coordination with Audits and Inspections team
Serve as Data Integrity Lead / SME during customer audits and regulatory inspections; prepare requested documentation for review by auditors & inspectors
Other duties as assigned