Johnson Matthey (‘JM’) is a global leader in science that enables a cleaner and healthier world. With over 200 years of sustained commitment to innovation and technological breakthroughs, we improve the function, performance and safety of our customers’ products. Our science has a global impact in areas such as low emission transport, pharmaceuticals, chemical processing and making the most efficient use of the planet’s natural resources. Today more than 14,000 Johnson Matthey professionals collaborate with our network of customers and partners to make a real difference to the world around us.
To execute and track improvements in the quality compliance activities and status required within the site operations to comply with cGMP and customer expectations related to active pharmaceutical ingredient manufacturing, with a major emphasis on real-time inspection readiness and quality metrics reporting. Assist with regulatory agency and client audits and prepare the response and monitor the implementation of any preventative and corrective actions. Have a through understanding in ICH guidance, FDA regulations, GMP’s, and Quality systems relevant to the manufacturing of pharmaceuticals.
- Lead the real-time inspection readiness programs at the site through design and execution of efficient, effective internal audits and compliance monitoring programs, including conducting and overseeing auditing activities.
- Lead GMP, and quality risk gap analyses, create and lead action plan teams.
- Perform Quality Risk Management assessments and support other departments during risk analysis assuring the inclusion of patient safety risk and customer concerns.
- Assist in customer complaint investigations and engagement with customer as needed for resolution.
- Assist in creation of GMP training program to include customer and agency inspection feedback
- Create fit-for -purpose implementation plans to address revisions in GMP regulations, ICH guidance and customer expectations.
- Manage the quality metrics monthly reporting to the global management team and create specific metrics monitoring plans to measure compliance program effectiveness.
- Lead customer quality audits, including audit responses and share voice of customer with extended compliance systems peers from other sites.
- Monitor audit observations, CAPA and investigations for trends, work across sites to create action plans which can be implemented across the sector.
- Improve and Manage the Supplier Quality Management program for service and material suppliers, including Supplier Qualification, risk assessments, performance management, and quality agreements
- Aid in the harmonization and maintenance of harmonization of the Quality Management Systems across sites, updating procedures, decision trees and compliance tools for the site, as needed.
- Manage vendor/supplier qualification evaluations, including audit of raw material vendors and service providers to ensure specifications are met.
- Manage receipt and distribution of directives, regulations, and inspection reports from regulatory agencies.
- Participate and coordinate FDA inspections, audits, and inspections by other regulatory agencies.
- Educate staff on Quality practices, including new hire quality orientation and compliance training.
- Other duties as assigned.
Are you the ideal candidate?
- BS in Chemistry or equivalent
- Expansive experience within a Quality function for an FDA/EMA/MHRA regulated industry
- Have previous experience auditing for cGMP compliance
- Experience with project management and gap assessment projects
- Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
- Experience with value stream mapping, SIPOC, dashboard creation, and lean tools
- Experience working in global, cross-functional teams for project execution
- Experience creating metrics for driving continuous improvement
- Experience with drug substance manufacturing
- Able to successfully interface with internal and external customers
- Excellent analytical, written and verbal communication and presentation skills
- Strong technical writing skills and the ability to clearly express ideas in English
- Ability to work independently and in a team environment
- Experience with Microsoft Office applications, including Word, Excel and PowerPoint at a minimum
- Expertise in FDA regulations, EU GMP, ICH Q7 and Part 11 compliance
- Experience in an Active Pharmaceutical Ingredient manufacturing environment
- Knowledge in organic chemistry
- Experience in applying and implementing GMP concepts in association with bringing a product through validation to commercialization