Briarfield Careers Gerard.jones@briarfieldcareers.com

Quality Manager

Milwaukee, WI Summary: In this role you will be responsible for Quality and management of Quality systems to ensure each department controls the Quality of products and services. Responsible for ensuring effective systems, measurements, policies, and procedures to evaluate and control process improvements are established and maintained per current applicable regulatory agencies and Customer requirements. In this FDA regulated facility, you will be responsible for knowledge of applicable FDA & EPA regulatory requirements, compliance to current policies and working with Corporate Director of EH&S to assure compliance in the plant. Primary Responsibilities:

• Provide adequate & effective training & work direction, leadership and developmental opportunities for Quality support staff - such as Quality Labs, Incoming Inspection, In-Process Inspection and Document Control. Provide frequent feedback to direct reports to assure performance goals are met.

• Responsible for being proactive in establishing and maintaining adequate resources – qualified employees and qualified equipment - in Quality to ensure the Quality system, applicable Regulatory & Customer requirements are effectively performed and maintained.

• Provide accurate, data-based & fact- based, thorough, on-time and effective response to customers – both internal and external.

• Establish good working relationships with all departments – at all levels – to assure interactive communication and relationships exist between Quality and other departments in the plant. Physically be present as much as possible – on some frequency each day – on the production floor, labs, warehouse, blending (each area) walking the floor to assure compliance.

• Assure effective GMP Compliant Quality System programs: CAPA, Calibration, Validation, Cleaning Validation, Supplier Audits and Internal audits are in place and maintained

• When bringing up or observing a problem – have a proposal or plan to resolve it upon presentation to management.

• Ensure the Corporate Quality Policy is implemented and maintained through the company. • Lead Coordination of plant preparation for external customer and applicable regulatory

inspections and third party Quality audits. Organizes and communicates effective responses and corrective & preventive action plans resulting from audits. Represents the company in a positive and professional manner during regular customer and vendor site visits

• Participate in, Implement and facilitate the ongoing application of Continuous Improvement throughout the plant.

• Develop and be responsible for annual, Quarterly and monthly Quality Budget Plan for each calendar year. Maintains monthly results, reports on the results to the Management team.

• Identify cost reduction projects, develop plan of action and timeline to accomplish completion

• Responsible for reviewing all Customer and Consumer Complaints received, the investigation and issuance of the resulting Quality Report to the customer. Responsible for identifying problems, concerns, or trends, communicating to responsible management, and ensuring corrective & preventive actions are taken and are effective. Communicates customer complaints to plant personnel on regular frequency.

• Provide leadership & direction in the development of new project/product proposals. Carefully review new product specifications and provide a thorough evaluation of the Quality Department’s capability to meet them at current state and also provide costs, equipment, staffing, plans it would take to meet the requirements if not already capable.

• Ensure adherence to safety rules. Report and correct unsafe practices and situations. • Communicate problems, situations, opportunities and progress to management. • Work with department managers and corporate staff to develop five-year business plans for

the company. • Provide accurate reports, as necessary. • Lead by example in attendance, timeliness, professionalism, adherence to current policies &

procedures and be a strong team leader for the company. • Support and participate in Lean philosophy, Kaizen events and Continuous improvement • Perform other duties as assigned by management.

Supervisory Skills: • Manage the quality support staff. • Responsibility for the overall direction, coordination and evaluation of this team, including

interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Language Skills:

• Ability to read and understand and interpret FDA Drug & Medical Device regulations. • Ability to respond to common inquiries or complaints from customers, regulatory agencies,

customer auditors, and members of the business community. • Ability to factually document events and findings. • Ability to effectively present information to top management and corporate

representatives. • Knowledge of Good Manufacturing Practices.

Computer Skills:

• Knowledge of Microsoft Office Education Requirements:

• Bachelor’s Degree (B.S. or B.A.), preferably in chemistry, microbiology or other technical science and 5+ years of direct experience in FDA regulatory compliance, coordination and implementation of quality systems and employee training.

• 5+ years leading and managing a Quality System and Quality Department in an FDA-regulated plant for Drugs and/or Medical Devices.

Monday – Friday; 7am – 4pm