Data Integrity Lead

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

Benefits offered by this job

health insurance

paid time off (PTO)

retirement contributions

Job summary

MilliporeSigma seeks a Data Integrity Specialist to ensure data integrity across lab, manufacturing, and IT systems supporting cGMP activities. You will develop and maintain policies, run Data Integrity assessments, and support audits with a focus on 21 CFR Part 11 compliance.

Lead trainings, coordinate investigations, update user requirements, and drive continuous improvement in data governance and system validation across the organization in the US.

Qualifications

• Bachelor's degree in CS/IT/Biology/Chemistry or Life Science.
• 10+ years with computer system validation and/or Data Integrity in pharma/medical device.

Responsibilities

• Ensure Data Integrity for all systems supporting cGMP activities across lab, manufacturing, and IT.
• Develop and maintain company policy and procedures related to Data Integrity.
• Develop training curricula and deliver training on data integrity policies site-wide.
• Provide coaching to ensure understanding of data integrity and regulatory guidelines for audits.
• Lead cGMP data life-cycle strategy and perform 21 CFR Part 11 assessments for new/upgraded systems.

Skills

Data Integrity

Computer System Validation

Regulatory Compliance

Leadership

Education

Bachelor's Degree in Computer Science, Information Technology, Biology, Chemistry, or 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:

• 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.
• 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:

Minimum 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.

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:

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

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!