Global Compliance Manager at Thermo Fisher Scientific in Pittsburgh, Pennsylvania

Job Description:

Work Schedule

First Shift (Days)



Environmental Conditions

Office



Job Description




Position Summary:



The Compliance Manager serves as the consultant for the quality management software platforms for the Quality Assurance, Regulatory Affairs and Legal departments of the Customer Channels Group (CCG) of Thermo Fisher Scientific. The Compliance Manager is the global application owner for the MasterControl software system.


The Compliance Manager is the central point of contact for Department personnel with respect to IT related matters and will serve as the liaison for the Department with IT. The Compliance Manager supports various quality driven functions, including analyzing data, and recommending and driving solutions in a regulated environment.


Key Responsibilities:


Global application owner and resource for MasterControl (web-based quality management software system) for storing and handling controlled documents and associated training records, and performing quality-driven actions.


Develop and implement test scripts as part of software validation for MasterControl upgrades and improvements. Author Standard Operating Procedures and work instructions for MasterControl. Train and coordinate with regional MasterControl administrators.


Collaborate globally with departments to understand processes and build strategic plans to create solutions supported by MasterControl, which mitigate risk to the overall division.


Collaborate globally with departments to develop and maintain training matrices based on job responsibilities/functions, which support our quality management system, ensuring we have validated training records to align with applicable requirements such as FDA QSR/GMP and ISO Standards.


Deploy metrics on MasterControl global training and develop effective strategies to ensure continuous improvement and efficiency of the quality system including presenting to global leadership and driving actions to ensure compliance.


Responsible to lead and conduct internal audits, identify gaps, assign risk rating impact, and provide corrective/preventive action support to ensure effective resolution to gaps. Also supports external and customer audits.


Lead Change Control process to ensure all changes, having an impact on quality of product or services provided by CCG, are identified, evaluated, and validated prior to implementation to satisfy cGMP and/or ISO 9001/2015 requirements.


Coordinate the preparation of the periodic quality management review for global CCG executive leadership, which covers the quality performance (complaint handling, CAPA, audit, etc.). Meets FDA QSR/GMP and ISO standards.


Act as the Process Manager for CCG's Legal Quality Regulatory and Compliance prioritization requests, facilitating the workflow from the initial concept through approval by the CCG leadership team.


CAPA Board member responsible for consulting, reviewing and approving the CAPA processes, handling issues/concerns with CAPAs not meeting criteria defined in CAPA plan.


Minimum Requirements/Qualifications:

• Bachelor of Science/Arts Degree, Information Systems Preferred


• 5+ years in a quality or compliance-related position


• Validated analytical and leadership skills with high attention to detail

• Familiarity with MasterControl (or similar Quality Management systems) desirable.

• Proficiency with Microsoft applications


• Must possess excellent communication, presentation and training skills.


• Must possess excellent communication, presentation and training skills.


• Ability to quickly learn systems!


• Ability to work in a dynamic, high pressure environment and meet tight deadlines.