Data Integrity Lead

The businesses of Merck KGaA, Darmstadt, Germany•Indianapolis, IN

3h•$104,100 - $156,100

About The Position

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.

Requirements

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.
External applicants must be eligible to work in the US.

Nice To Haves

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.

Responsibilities

Execute and review Data Integrity Assessments and Security Reviews for all systems that contain processors and/or generate data, including lab, manufacturing, and IT-based systems used in support of cGMP activities.
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 affected personnel understand Data Integrity processes and regulatory guidelines in preparation for internal/external audits.
Run meetings and advise functional areas from a cGMP perspective on strategies for the life cycle management of data residing within computer systems (collection, storage, maintenance, backup, recovery, archival, retirement).
Perform (lead) cGMP gap assessments with functional areas for current data collecting systems against cGMP and current industry expectations.
Aid/develop 21 CFR part 11 assessments for new and upgraded systems and software.
Manage meetings to drive closures of all Data Integrity Gaps.
Update system User Requirements, as necessary.
Review and approve Data Integrity change controls, deviations, and protocols finalized by other functional areas.
Investigate, develop, and implement permanent corrective and preventive actions for process/system failures to continually improve Computer Systems Data Integrity.
Coordinate investigations to determine root causes and actively participate to develop and propose changes to prevent reoccurrence of issues.
Perform other Quality System and Data Integrity functions as assigned to drive compliance and continuous improvements.