Job Description

WHY PATIENTS NEED YOU

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.

WHAT YOU WILL ACHIEVE

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.

HOW YOU WILL ACHIEVE IT

• 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

QUALIFICATIONS

Must-Have

• 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

Nice-to-Have)

• Demonstrated use of Data Integrity principles and concepts

• Demonstrated presentation skills to customers at various levels, with good written and verbal communication skills

• 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

OTHER JOB DETAILS

• Last Date to Apply for Job: May 25, 2026.

• Additional Location Information: N/A

• Eligible for Relocation Package – NO

• Secondment 12-18 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.

• There will be no change to your current work location.

• Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

• Work Location Assignment: On Premise

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Pfizer endeavors to makewww.pfizer.com/careersaccessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please emaildisabilityrecruitment@pfizer.com This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

Quality Assurance and Control