JOB DESCRIPTION SUMMARY

As the Global Sterility Assurance Leader, you’ll be responsible for the management and development of Sterility Assurance Programs and ensuring compliance with all sterility assurance regulations and industry best practices with specific emphasis on Annex 1 within Pharmaceutical Diagnostics (PDx). This role will either report to the Senior Director Global Compliance & Quality Systems PDx or the Global Quality Risk Management & Complaints Leader.
This role will own the strategy and implementation of Sterility Assurance improvement programs which will range from setting the standard for Sterility Assurance across the network, the development of a refreshed Sterility Assurance training program (i.e. Aseptic Excellence), aseptic vs terminal sterilisation manufacture, clean room behaviours, CCS and relevant risk management strategies and basic principles & best practices relating to OOS investigations, and other areas as relevant. This will include the development and implementation of new tools and new processes which will to be rolled out globally to all functions within the PDx business.
This role will be responsible for further improvements and development of TrackWise Digital OOS module – developing the workflows and module design. All SOP updates and training material for these modules will be under the responsibility of this role.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree and extensive experience within the pharmaceutical industry
• Strong communication skills
• Strong project management and prioritization skills, ability to effectively manage multiple tasks and priorities
• Superior ability to lead change with global, cross-functional teams
• Proven ability to drive operational excellence

• Responsible for the generation, planning and overall execution of the Global Sterility Assurance strategy.
• Responsible for the generation, planning and overall execution of new standardised processes starting with a global OOS standard and setting the expectations for Aseptic Excellence.
• Develop and execute the roll out of Sterility Assurance training.
• Define a new strategy to improve the update and adoption of Global Procedures with the removal of Local procedures which have the potential to drift from the global standard.
• Define the standard of technical writing of investigations associated with sterility assurance and OOS investigations to improve this across PDx.
• Monitor external industry trends. Influences industry standards by participation in relevant industry working groups. Provides expertise and guidance on regulations and standards
• Manage the Sterility Assurance COE team across PDx and mentor the Sterility Assurance SMEs at the GE HealthCare PDx manufacturing sites
• Supports regulatory inspections and internal audits including responses across PDx as the PDx Global Sterility Assurance SME. Conducts site Sterility Assurance audits or reviews as necessary or requested. Assists as SME with supplier audits where requested.
• Develop a program to support continuously improving Microbiology testing and test method validation (e.g., bioburden, sterility and bacterial endotoxin), Microbial identification systems and rapid microbiology methods
• Support the development of the standardised Sterile barrier integrity within PDx including container closure integrity methods over the labelled shelf life of the product
• Develop a program to support continuously improving how environmental monitoring is conducted in PDx (viable and non-viable, humidity, temperature and pressure) and management of controlled environments (cleanrooms, isolators and restricted access barriers with appropriate smoke visualisation)
• Develop a new set of metrics to manage and monitor Sterility Assurance activities and program adherence with the support of the Global Data Analyst and roll out to all departments.
• Lead the knowledge increase of Sterility Assurance to non GxP personnel.
• Develop continuous improvement processes to ensure that the overall sterility assurance program remains current and is aligned to the regulations
• Support the PDx Quality Risk Management program and deputise where relevant
• Liaise with all levels of the organization on Sterility Assurance matters.
• Keep up to date with latest guidelines from MHRA, FDA, EMA and other Regulatory bodies