QA Manager, Data Integrity and Compliance


Job ID 18-00210

Industry Pharma

Job Type Permanent

Location Decatur, IL

Description

Summary:
Manages, implements and coordinates quality assurance program to prevent or minimize risk to the integrity of data at the Decatur site. The QA Manager of Data Integrity and compliance provides independent oversight to the data integrity program for the facility including data generation and review. This individual will work in a detail oriented, compliant manner to ensure the facility operations align with Company policies and procedures as well as cGMPs and industry data integrity expectations. The QA Manager of Data Integrity & Compliance will assist in hosting audits and tracking audit responses to ensure they are timely and complete. The QA Manager of Data Integrity & Compliance reports directly to the Director of Quality Assurance.
 

Essential Functions:

  • Develop and maintain Data Integrity System for the site, including ownership of Data Integrity SOPs, development
  • Audits data from Quality Control Laboratories (Chemistry and Microbiology)
  • Oversees the investigation of discrepancies in Quality Control Laboratories
  • Performs reviews of site NDA/ANDA filings
  • Provides oversight to the Commercial and ANDA stability programs.
  • Provides oversight and administration of GMP-IT Systems (Computerized data systems)
  • Review/close out any aborted or rejected batch records.
  • Review/close out any non-commercial (ANDA Exhibit, Engineering etc.) batch records.
  • Review/close out all media fill batch records.
  • Provides data from batch record review and stability reports for analysis during annual product reviews.
  • Review method validation/verification and transfer protocols and final summary reports/data.
  • Review process validation/verification protocols and final summary reports/data.
  • Review validation qualification and requalification protocols and final summary reports/data.
  • Performs pre and post review/approval of change controls and associated action plans/validation activities.
  • Assist in hosting, Internal, Customer and Regulatory Agency.
  • Conduct routine Data Integrity related training.
  • Provides and tracks responses to audit observations and deficiencies.


Qualifications

Candidate Details
5+ to 7 years' experience
Seniority Level - Mid-Senior
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally