Responsible for developing, assigning responsibility, implementing, and monitoring the Cambridge, OH site Quality Plan. This includes delivery of training and execution of methodologies to enable the manufacturing site to deliver consistent, safe, and effective products. Responsible for managing the site’s Quality Audit Program to ensure conformance with standards and Quality-related regulatory requirements. The individual will also leverage audit results and other data based Key Performance Indicators (KPIs) to identify and drive continuous improvement opportunities and reduce variation and waste.
Execution of all Quality Systems in the plant
Define and implement and execute the site-specific Quality Plan, including Quality Management strategies, direction, and policies with the goal of protecting the business, reduction of variation and waste, and growing the business.
Ensure site compliance with the company's Global Quality Standards, current Good Manufacturing Practices (cGMPs) and local Regulatory requirements
Interface with Company Regulatory and Legal Departments to address local regulatory issues and to communicate with local regulatory agencies.
Has highest ranking site-wide accountability for the robustness of key Quality Systems including but not limited to Incoming Component & Finished Product Inspection & Release, Validation, Corrective & Preventive Actions, Change Control, Internal Audits, Laboratory Management and Documentation Management.
Lead the site-wide quality/compliance inspections from regulatory agencies as applicable.
Accountable for leading (in cooperation with other site Leadership Team members) the development and implementation of action plans to address audit findings from external quality/compliance audits and internal company cGMP audits.
Leverages audit results and other data-based Key Performance Indicators (KPIs) to identify and drive continuous improvement opportunities and reduce variation and waste.
Accountable for the site-wide consumer satisfaction programs such as Consumer Complaint Tracking & Reduction and the On-Shelf-Quality Program.
Ensure the onboarding and safety training of lab technicians that will be working on or around the Process Safety Management (PSM) covered processes to obtain quality and micro samples.
Work with Operations and PSM Coordinator to ensure that new technicians are in compliance with site policy for working on or around covered PSM processes.
Complete a PSM 100 workshop within one calendar year from hire date.
Has primary accountability for all Performance Management and Coaching / Feedback activities for all members of the Quality Organization at the site.
Is a key member of the Site Leadership Team, and ensures that the Quality Organization effectively contributes to key business building activities such as customer service, cost savings and Technology Transfer
Ensures that appropriate Statistical Process Control (SPC) tools are effectively used in key site processes to drive continuous improvement.
Measure Divisional KPIs and report progress to Senior Management.
Bachelor's Degree (or equivalent university degree) in Chemistry, Microbiology, Biochemistry, Engineering or related field.
At least 10 years of experience in Quality, Supply Chain or Research & Development
At least 5 years of experience in a Manufacturing/Plant Operations environment
At least 5 years of experience conducting and facilitating effective Failure Investigations, Corrective and Preventive Action, Notices of Deviation and Management of Change Documentation
At least 5 years of experience in a regulated industry i.e., FDA, EPA, or OSHA
Direct experience with active participation in an FDA or EPA inspection of a site is required.
Experience in a leadership position for hosting an FDA or EPA inspection is highly desired.
2 years using statistical tools such as Minitab, SPC
5 years of supervision experience
2 years of experience in a Technology Transfer role
Experience using SAP or other plant-related computer systems