JOB PURPOSE:    
Oversees and directs teams of Analytical Chemists, Microbiologists, and Laboratory Professionals who are responsible for chemical and microbial analysis of all incoming raw materials, bulk product, finished goods, water samples, environmental monitoring samples, and cleaning validation samples.  Collaborates and partners with cross functional teams (Operations, R&D, and Engineering) to ensure that department critical path testing responsibilities are completed on a timely basis in support of Mary Kay business needs. Establish and implements policies, strategies and relevant initiatives that ensure compliance with US FDA requirements and GMPs. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:     
1. Possesses strong technical expertise in Microbiology and Analytical Chemistry providing oversight, technical expertise and guidance to the Analytical Chemists and Microbiologists testing raw materials, bulk product, and finished goods in a cGMP compliant laboratory environment. Anticipates and stays abreast of industry technology and regulatory compliance related to Quality Control testing.

Manages the technical quality control analytical and quality control microbiology functions.  Plans, initiates, and supervises the systematic chemical analysis of finished goods, bulk products and raw materials to meet defined objectives.  Supervisory and leadership responsibilities may include staff coordination/workload assignment, conducting performance appraisals, coaching, mentoring, disciplinary actions, training, and succession planning.  Staff competency assessment and train-the-trainer initial certifications. Provides technical direction to staff members.

Develops systems and implements new methods and procedures to improve efficiency and flexibility of all QC Analytical and Microbiology operations. Establishes metrics, monitors results, and implements systematic improvements as needed to meet and align with overall strategic objectives for the Company and Quality.  Maintains or implements quality systems to ensure compliance with FDA regulations and business objectives. 

Plans and coordinates activities for the QC Analytical and Microbiology departments by creating and refining the structure and framework of each department, manages risk, and ensures goals are accomplished in accordance with prescribed priorities, time limitations, and funding conditions.  Provides technical direction and supervision to direct reports to help meet established schedules and/or resolve technical or operational problems.  Ensures ongoing training and development of staff; coaches staff and provides staff with succession planning; prepares and administers performance reviews; and develops and maintains a safe, positive working environment for the department.

Effectiveness is measured through KPI’s such as turnaround time, compliance and prevention of repeat quality issues.  Failure for the managed teams to provide accurate and timely product evaluations will have a serious detrimental impact on global product availability potentially resulting in backorders and loss of sales.

 
2.     Interfaces with Supervisors, Managers and Directors of Production Operations, Research and Development, Marketing, Brand, Contract Services, Planning, and Distribution by responding to in-house technical questions or problems related to product quality.  Serves as in-house expert and liaison to other functional units by responding to technical questions related to product quality, statistical data analysis, statistical quality control, sampling plans, or quality methods.  Insures the timely gathering of all relevant data when out-of-spec (OOS) results or conditions are noted either by the Quality teams or other departmental personnel.  Provides REWORK instructions for bulk products that are suitable candidates. 

3.     Provides key leadership to resolve product quality, technical or operational issues. Works with Plant Operations groups, Process Development, Commercialization, Purchasing and Quality Engineering to investigate external and internal quality and compliance related issues.  Works to resolve these issues with QC staff and high-performance teams as required.  Proactively identifies and implements processes, policies or procedures to continuously improve the product and compliance quality of Mary Kay, Inc.  Develops and recommends solutions to prevent future occurrences.  Makes policy and procedure changes as necessary.  Follows up to verify that changes in the systems are implemented and monitors the systems over time to verify improvement.

4.     Supervises the FDA compliance function for QC Analytical and Microbiology laboratory generated documents including batch and test record review, collection of legal retains, system suitability, and control sample testing.  Checks and verifies the analytical results generated by the laboratory staff.  Ensures that the operations of the laboratories are conducted under GMP compliant conditions.  Maintains appropriate calibration and maintenance records for all instrumentation. Performs or oversees the IQ/OQ/PQ of analytical instrumentation when appropriate.  Oversees the operation and maintenance of lab equipment used in the testing of bulk products, raw materials, finished products, validation samples, water samples, environmental monitoring samples and troubleshooting samples.  Monitors and measures team performance and identifies technical training requirements for staff. 

6.     Prepares the annual operating and capital budgets for 1 cost centers of approximately $1M. Monitors and approves expenditures for the laboratory cost center and monitors costs to ensure compliance with budget limitations.  Manages short term and long-term planning for capital expenditures required to maintain QC Analytical laboratory and Microbiology equipment in good order, identifying and justifying equipment needed for the most efficient and effective operations of these laboratories.