Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-UYEQC1 QMS
Recruiter: Leah S Westley
This information is for internals only. Please do not share outside of the organization.
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
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
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.
Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites. For more information click here.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.
Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.