Dir Global Quality Assurance

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JOB PURPOSE:    
Assures the quality of all products produced by and for Mary Kay Inc., including Dallas manufactured and U.S. contract manufactured goods, as well as all products produced by contract manufacturers globally under the Mary Kay Inc. name.   Provides technical guidance, support, expertise and advice to Mary Kay quality organizations worldwide. This job directly oversees:

• The DALLAS SITE Quality area, including:

o QA Department, which assures the quality and compliance of all finished goods produced in house by Dallas manufacturing and by contract manufacturers shipped through ASRS,

o the QC Analytical Department, which assures the quality and compliance of all raw materials and bulk products,

o the QC Components Department, which assures the quality and compliance of all packaging materials used in Dallas manufacturing, and

o the QC Microbiology Department, which assures the microbiological efficacy and safety of all ingredients, bulks, components, and finished goods

• The QUALITY ENGINEERING area, which manages FDA compliance, facilitates root cause analysis as part of complaint investigations, tracks quality trends and identifies opportunities for improvements, and participate in NPD activities to ensure Quality by Design

• The VALIDATION ENGINEERING area, which supports equipment IQ/OQ/PQ, Prospective Process Validation, Packaging Validation, and Cleaning Validation activities in accordance with FDA regulations.

• The QUALITY SYSTEMS area,  which ensures that site staff has full understanding of quality processes and procedures, facilitates and leads external regulatory inspections, and  accountable for site quality activities such as CAPA program, QSIT System, Finished Good Specifications, Batch Record Review, Annual Product Review, Change Control, Internal Audits, and Inspection Readiness. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:     
1. Directs a staff responsible for SITE QUALITY - all quality assurance and manufacturing compliance functions, ensuring the quality and compliance of all manufactured and contracted products produced for Mary Kay Inc.  This includes the departments of Quality Control Analytical, Quality Assurance Finished Goods, Quality Control Components, and Quality Control Microbiology. Directs a staff responsible for QUALITY ENGINEERING - manages FDA compliance, CAPA, engineers systems to improve quality, tracks quality trends and identifies opportunities for improvements. Directs a staff responsible for VALIDATION ENGINEERING – supports equipment IQ/OQ/PQ, Prospective Process Validation, Packaging Validation, and Cleaning Validation activities in accordance with FDA regulations.  Interviews, hires, coaches and facilitates performance evaluation and career planning for the Managers and Group Leaders of these groups. Guides Managers and Group Leaders in developing safe and productive working environments for all departments.

2. Interacts with VP and Director levels globally of Production Operations, Corporate Quality, Technical Information, Regulatory, Purchasing/Contract Services, R&D and Brand to:

• Resolve technical issues related to product quality.

• Develop and implement strategies to proactively improve product quality and increase customer satisfaction and market share.  

3. Directs the systematic acquisition of technical product quality data to support strategic direction, analyzes and communicates trends as well as recommendations to address unfavorable trends, determines corrective actions to be taken, and provides the corporation with strategic technical direction based on customer requirements.   Follows up to ensure future actions respond to customer needs and trends. Interacts with top level independent sales force members to gain insight and relevant feedback for the quality system.

4. Develops operating plans, objectives, and related budgets for a rolling 3-5 year plan for all departments.  Maintains expenditures within budget to meet cost of sales objectives.

5. Ensures all U.S. manufacturing systems and applicable International sites are in compliance with 21 CFR 210 and 211.  Acts as key liaison for FDA inspections of the Dallas manufacturing site.

6. Acts as a key member of the site leadership team which consists of other Directors and Vice Presidents and oversees the activities of all U.S. operations.

7. Provides direction to quality improvement teams to improve customer satisfaction and reduce manufacturing costs. Allocates resources and provides strategic direction for the Quality Assurance, Quality Control, and Quality Systems groups to minimize corporate risk and improve corporate profitability.

8. Monitors industry trends in quality, formulates and implements updates to the quality engineering strategy, systems and policies of Mary Kay Inc. to stay abreast with industry and technological trends. Seeks incorporation of scientific and technological advances in the laboratory in a proactive manner.  Maintains an understanding of current Food & Drug Administration (FDA) regulations, Good Manufacturing Practices, and Good Laboratory Practices.

KNOWLEDGE, SKILLS AND ABILITIES:    
Education:  Bachelor’s degree in Engineering or Science field or equivalent. Master’s degree preferred.

Experience: A minimum of 10 years related work experience or a Master’s degree with 7+ years related work experience or a Ph.D. in a Biology discipline with 5+ years related work experience working with technical, regulatory and manufacturing aspects of FDA related consumer products.

1. Must possess strong technical skills and experience with GMP in addition to an advanced knowledge of quality audits, statistics, quality improvements, product development, chemistry, and liquid mixing and filling operations.  Certification by ASQ as a CQMgr or CQE is preferred.

2. Must possess strong leadership abilities in order to oversee departments, provide guidance and direction to Managers, and to develop and motivate employees to reach goals and objectives.

3. Excellent communication abilities are required to interface with all levels of upper management. 

4. Must have the ability to understand business needs and strategically plan the most cost-effective solution to goals and objectives requires the ability to motivate and influence others and the ability to effectively work on teams.

5. Must be able to provide solutions to a wide range of difficult and complex problems which require the regular use of ingenuity and creativity. 

6. May be required to travel up to 25% of the time.

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