Data Integrity Lead

MilliporeSigma; Indianapolis (IN); On-site; USD 104,000 - 156,000; Full time

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Other prerequisites

Job summary

MilliporeSigma in the United States is seeking a cGMP Data Integrity Specialist to ensure data integrity across GMP systems, align with SOPs, and support global governance.

This role leads audits, develops policy, trains staff, reviews change controls, and drives continuous improvement to prevent data issues.

Qualifications

• Bachelor’s Degree in Computer Science, Information Technology, Biology, Chemistry, or other Life Science discipline.
• 10+ years experience with computer system validation and/or Data Integrity in pharmaceutical/medical device industry.

Responsibilities

• Data Integrity for GMP systems across lab, manufacturing, and IT environments.
• Develop and maintain company policy and procedures related to Data Integrity.
• Develop training curricula and provide training on data integrity policies site-wide.

Skills

Data Integrity

Computer System Validation

Regulatory Knowledge

Leadership

Communication Skills

Education

Bachelor's degree

Life Science

Job description

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

This position is responsible for data integrity for GMP systems, ensuring they are aligned with cGMP expectations, internal SOPs and requirements, and global governance. Provides auditing support for the Quality Compliance department as it relates to Data Integrity.

Responsibilities Include But Are Not Limited To

• Data Integrity for all systems that contain processors and or generate data including lab, manufacturing, and IT based systems utilized in the support of cGMP activities, including executing and reviewing Data Integrity Assessments and Security Reviews.
• As the cGMP Data Integrity Specialist, develop and maintain company policy and procedures related to Data Integrity.
• Develop training curricula and provide training for and enforcement of data integrity policy and procedures site wide. Provide ongoing coaching to ensure effected personnel understand Data Integrity process and regulatory guidelines in preparation for internal/external audits
• Runs meetings and advises from a cGMP perspective, the functional areas on strategies for the life cycle management of data residing within computer systems (i.e., collection, storage, maintenance, backup, recovery, archival, retirement).
• Perform (lead) cGMP gap assessments with the functional areas for current data collecting systems against cGMP expectation and current industry expectations. This includes aid/develop 21 CFR part 11 assessments for new and upgraded systems and software. Manages meetings to drive closures of all Data Integrity Gaps.
• Update system User Requirements, as necessary.
• Review and perform approval of Data Integrity change controls, deviations and protocols finalized by other functional areas.
• Continually improve Computer Systems Data Integrity by investigating, developing, and implementing permanent corrective and preventive actions for process/system failures. Coordinate investigations to determine root causes and actively participate to develop and propose changes to prevent reoccurrence of issues.
• Other Quality System and Data Integrity functions as given to drive compliance and continuous improvements.

Who You Are:

• Bachelor’s Degree in Computer Science, Information Technology, Biology, Chemistry, or other Life Science discipline.
• 10+ years experience with computer system validation and/or Data Integrity in pharmaceutical/medical device industry.

Preferred Qualifications

• Leadership, negotiation, and conflict management skills.
• Strong knowledge of EU, FDA and cGMP regulations related to the pharmaceutical and biotechnology industry.
• Excellent interpersonal effectiveness and written communication skills.
• Ability to influence and work independently and in a team environment.

Pay Range for this position: $104,100- $156,100 / year

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites.

• health insurance
• paid time off (PTO)
• retirement contributions
• other prerequisites

Position may be eligible for sales or performance-based bonuses.

For more information click here.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!