Lead and direct activities in the area of Quality Operations for incoming, compounding and filling & assembly
Manage and maintain quality audit, inspection and product release programs for incoming, in-process and finished good materials.
Lead and facilitate the non-conformance management process, along with consumer/customer complaint resolution and reduction activity.
Manage and maintain the component certification process for incoming components. Continuously build and sustain relationships with vendors ensuring appropriate corrective/preventive actions are effectively implemented.
Determine & implement product dispositions regarding holds due to higher level quality & regulatory issues. Support determination & implementation of product dispositions regarding holds, warehouse, transport, & logistics issues. Serve as information manager in event of product recall.
Provide QA support, review and approval for relevant documents including relevant, test procedures, specifications, technical reports, trend reports, Annual Product Quality Reviews
Act as a key interface to Production management in Compounding/Filling & Assembly
Have oversight over top quality issues on the shop floor and lead the communication of quality problem notification / resolution between Manufacturing, QA, Engineering, Facilities, Validation, and R&D regarding out-of-specifications.
Drive Root Cause Analysis and actively pursue timely response and final preventive resolution to quality issues.
Where needed, work with suppliers on the resolution on individual complaints, and engage supplier QA and GSR in the discussions if no immediate resolution is available or where broader discussions need to take place
Drive implementation of quality improvement initiatives on the shop floor with Quality Engineers, Operations and other stakeholder groups
Review Quality metrics and define and implement action plans to positively influence scorecard results.
Share \"best practices\" globally with Quality Process Improvement team and other Quality sites
Ensure that the manufacturing (and distribution practices, where applicable) at the site are compliant with all ELC global guidelines and regulatory requirements
Ensure regulatory readiness
Personnel Management & Training (20%)
Ensure alignment of performance objectives for staff to both Company's and QA Strategy goals. Ensure performance is reviewed against those objectives.
Work with Quality leadership team for proactive succession planning and a high performance culture through people.
Provide the coaching, mentorship and training necessary to support ongoing personal and professional development of Quality Operations
Support the development and execution of quality training curriculum for Quality Operations
4 year degree or equivalent experience
Minimum Years of Experience: 10 years
Minimum 10 years experience in managerial / leadership positions, preferable in Fast Paced Consumer Goods manufacturing environment a plus (Cosmetic, Food, or Pharma)
Successful in managing/leading multiple functional areas within the Quality Assurance team (Components, Compounding and Filling) in a cGMP environment
Requires experience in developing and implementing SOPs, Test Methods, and root cause problem solving techniques
Excellent oral and written communication skills and ability to appropriately communicate information to cross functional stakeholders and suppliers
Strong leadership and human relation skills
Expertise and ability to execute statistical sampling, AQL/ANSI interpretation, and read/interpret specifications, drawings and compounding/assembly instructions
Experience in developing and implementing quality systems, and driving strong GMP practices within a large manufacturing site.