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The QA Director, Global Data Integrity Program will own the Global DI Program that ensures compliance to regulatory requirements at all Pharmaceutical Services Group (PSG) sites. In addition to ensuring implementation at all sites, the candidate will drive practical improvements and will develop and monitor Key Performance Indicators to measure the effectiveness of the program.

Requirements

• Proficient in the application of 21CFR Part 11, Annex 11 and other applicable regulations
• Ability to evaluate and resolve complex technical problems by using network resources.
• Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.).

Responsibilities

• Stay current on global regulations and expectations and industry trends related to data integrity. Update global policies and procedures and other program elements to maintain a state of regulatory compliance.
• Help sites resolve challenges in program implementation, instrument/equipment remediation, etc.
• Stay current with industry standard processes through benchmarking and active participation in industry groups such as PDA and ISPE.
• Lead a Global Community of Practice for information sharing between sites.
• Assist sites with data integrity risk assessments and mitigation/remediation plans.
• Analyze metrics and address trends to Site Quality Heads and General Managers and Division Quality VPs.
• Use PPI (Practical Process Improvement) methodology to develop or improve processes that enable sites to improve documentation and data integrity requirements.

Other

• 10 years plus experience in pharmaceutical manufacturing, or pharmaceutical laboratory testing with confirmed experience leading data integrity programs.
• Proven ability to influence and lead professional multidisciplinary staff in order to achieve goals.
• Experience with external surveillance and searching for latest information related to data integrity and quality culture.
• Ability to drive functional, technical, and operational excellence.
• Work independently with little supervision, especially remotely.
• Ability to develop an internal strategic network while working remotely.
• Strong written and verbal communication skills and effective presentation skills with specific emphasis on upwards communication.
• This position requires ability to work with computer systems.
• 25-50% domestic and/or international travel may be required.
• Ability to clearly communicate verbally via Web-based conferencing platforms.