Director, QA Data Integrity

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

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.

Education / Experience

• Bachelor’s Degree or higher in Pharmacy, Engineering, Science or other applicable degree with relevant work experience. 
• 10 years plus experience in pharmaceutical manufacturing, or pharmaceutical laboratory testing with confirmed experience leading data integrity programs.
• Proficient in the application of 21CFR Part 11, Annex 11 and other applicable regulations

What You Will Do:

• 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.
• Support sites in explaining the Data Integrity Program for regulatory and client audits as needed.
• Develop training content that global and site training coordinators can deploy.
• Take on other duties/projects as assigned to support the Global Quality Compliance Team as required.

Knowledge, Skills, Abilities

• 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 evaluate and resolve complex technical problems by using network resources.
• 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.
• Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.). 
• Strong written and verbal communication skills and effective presentation skills with specific emphasis on upwards communication.

Physical Requirements

• 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.

Compensation and Benefits

The salary range estimated for this position based in North Carolina is $145,500.00–$218,250.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards