Site Data Integrity Manager (Secondment 12-18 Months)

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 bachelors degree with at least 5 years of experience; OR a masters degree with at least 3 years of experience; OR a PhD with 0 years of experience; OR as associates 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 includingrisk 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 for12 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.