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Director Quality
Estee Lauder
Blaine, MN, United States
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Position Summary:
This position will lead and direct all Quality activities within Operations at the Blaine site (for incoming, compounding and filling & assembly) and is responsible for helping establish and implement the site Quality strategy. This will include overseeing the development and implementation of corporate and local SOPs supporting product release. The person will be responsible for managing the Quality staff and associated programs to ensure that ELC maintains our high standards of regulatory compliance regarding commercial product release testing of cosmetic and over the counter drug products. This technical management position requires a high degree of quality operations expertise and working knowledge of SOPs, FDA guidelines and cGMP’s within a cosmetics manufacturing environment. Experience with over the counter drug manufacturing is desirable.
Job Description:
Lead Quality Operations Activities and Product Release (40%)
• Lead and direct activities in the area of Quality Operations for incoming, compounding and filling & assembly
• Manage and maintain Estee Lauders 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
Issue Resolution / Complaints / Continuous Improvement (20%)
• 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
Compliance (20%)
• 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
Qualifications
Minimum Education Level: 4 year degree or equivalent experience
Minimum Years of Experience: 10 years
Additional Job Specifications:
• 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.
Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems is preferred