Data Integrity Program Manager - Quality Control
About The Position
The QC Data Integrity Program Manager identifies, implements, manages, and maintains strong Data Integrity Compliance activities within the Quality Control Department. The QC Data Integrity Program Manager will be responsible for ensuring compliance and alignment to all relevant regulatory and internal requirements related to data integrity as well as developing training material and leading training efforts with Quality Control Staff. Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.
Requirements
- 8+ years of relevant/relatable experience in data integrity, quality oversight of computerized system management/validation, QA compliance/regulatory and/or similar areas of focus
- Must be familiar with use of electronic data management and laboratory information management
- Thorough knowledge of regulatory issues and the impacts on discipline
- Expert knowledge on industry data integrity principles and applicable regulations such as 21 CFR Part 11, EU Annex 11, MHRA GxP Data Integrity Requirements
- Advanced and deep knowledge of principles, concepts, and practices in discipline, known as a SME in that discipline, and good knowledge of principles and concepts of other relevant disciplines
- Excellent organization and planning skills
- Strong attention to detail and ability to adhere to standards procedures
- Strong understanding of Computerized System validation principals
- Ability to drive functional, technical, and operational excellence
- Working understanding of applicable QC computerized systems and how they interact such as Empower, Softmax, ViPER Analytx, and other similar software
- Good understanding of the complexity, interactions, and dynamics within an international company
- Experience supporting client or regulatory audits as it applies to Data Integrity
Nice To Haves
- Experience in quality system management (e.g., deviations, change controls, SOPs) is preferred
- Strong project management skills and ability to lead effective change management are desired
Responsibilities
- Implement and maintain Data Integrity compliance activities for all Quality Control systems in alignment with relevant regulatory regulations and guidelines
- Represent Rentschler as the QC subject matter expert during client and regulatory inspections related to data integrity
- Manage remediation efforts to identify data integrity gaps and risks and implement appropriate technical and procedural controls as required
- Provide oversight of data integrity compliance for software and instrument validation lifecycle activities associated with QC computerized systems to ensure conformance to GxPs, guidance documents, applicable industry standards, and Rentschler business practices
- Develop training material and lead training efforts with SMEs as it relates to Data Integrity principals and best practices
- Effectively manage and execute strategic business opportunities to improve business processes
- Provide day to day oversight for the governance, management and coordination of activities in QC related to Data Integrity
- Work cross functionally with other departments to provide, support, guidance, and feedback on applying appropriate Data Integrity controls and best practices
- Author quality system documentation such as change control, deviations, CAPAs, SOPs, work instructions
Benefits
- annual discretionary bonus program
- medical insurance
- generous 401K program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
