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Director, QA, Global Deviation

3 months ago

Allentown, United States Thermo Fisher Scientific Full time

The Director of Quality, Deviation & CAPA Management leads the development, deployment, and improvement of the global deviation and CAPA program to improve the management and quality of investigations for all PSG sites. This position will work closely with global and PSG manufacturing sites worldwide to ensure alignment and execution of the deviation and CAPA management system. This leader will ensure harmonization, simplification, and efficiency of this quality system. They will lead the investigation certification program, monitor performance of metrics and partner to drive improvement.

**Responsibilities**:

- Ability to set clear direction and to effectively lead and manage a team.
- Develop a strategy for Deviations & CAPAs in alignment with the business objectives.
- Deviation and CAPA Business process owner within Global Quality Systems
- Standardize and harmonize the quality system across all PSG sites.
- Leads global quality improvements for deviation investigations and CAPAs including product complaints for a wide network of business units (drug substance large and small molecule, drug product, viral vector services, and clinical trials division).
- Continuously support enhancement and improvement of the deviation management system.
- Maintain oversight of deviation and CAPA quality including effectiveness checks
- Support inspection readiness for deviations and CAPAs across all PSG sites.
- Lead and support project alignment through the maintenance of policies and procedures, business review, trending, monitoring Key Performance Indicators, and inspections.
- Lead and develop the certification program and trainings to improve site capabilities for all elements of investigations including data collection, report writing, root cause analysis, and CAPA management.
- Maintain and continuously improve our Power BI dashboard to drive improvement.
- Support the AI program to ensure that deviations are effectively addressed and that compliance with regulatory standards is maintained. This includes utilizing AI tools to identify and analyze deviations, providing guidance on appropriate CAPA actions, and ensuring that all necessary documentation and reporting is completed accurately and in a timely manner.

**How will you make an impact?**

You will lead the execution and oversight of a global quality system to ensure we are able to deliver on our mission.

**What you will do**:

- Implement and manage PSGs deviation management program including the certification/qualification and training of deviation investigators and approvers.
- Educate and communicate awareness of the principles of the deviation and CAPA program based on technical skills and behavioral change management.
- Identify and communicate issues, trends, and opportunities up and to senior global quality leaders.
- Maintain processes, procedures, and practices according to internal and regulatory expectations.
- Maintain a monitoring system for site/global metrics to track progress and effectiveness of the program and provides management dashboards to monitor/address issues and trends.
- Develops division/site strategy for continuous improvement towards objectives through business review, trending, and inspections.
- Develop a communication strategy for inter and intra site.
- Champion a site wide network of communication to promote the growth of the individuals using online forums, social media, conferences, and global policies.
- Lead the PSG Community of Practice for Deviation and CAPA management.
- Collaborate with site leadership to strategize implementation, execution, and continuous improvement.
- Perform mock audits on investigations and CAPAs through sampling on a periodic basis.
- Coach and mentor site deviation owners and approvers through real time support on key investigations. Including support key investigations as an SME or lead investigator as necessary.
- Maintain a knowledge base of current external and internal trends and standards for regarding deviation and quality management.
- Improve the technical capabilities of site personnel through feedback and modeling expectations as a SME on abilities such as risk management, root cause analysis, statistical process control/analysis.

**Qualifications**
- Bachelor’s Degree or higher in Chemistry, Biochemistry, Engineering, or other physical science degrees with relevant work experience.
- Minimum of 10 years’ experience in pharma/biopharma regulated industry (GxP) with strong direct hands-on pharmaceutical experience in deviation and CAPA management systems
- Demonstrated leadership across functions and organizational levels.
- Demonstrate the ability to incorporate sound risk management fundamentals
- Embodies our Thermo Fisher values of Integrity, Involvement, Intensity, and Innovation.
- Demonstrates excellent interpersonal verbal and written communication.
- Six Sigma certified or Taproot RCA Certified Trainer is a plus
- Project management skills for delegating data co