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Manufacturing Manager - (FDA/ GMP)

LanceSoft INC
Irvine, California, United States
April 27, 2018


Position Summary:

Under direction of Business Unit Director oversees product manufacture within the functional area. Co-develop and execute strategic plans to achieve short and long term business objectives. Ensure timely and efficient manufacturing of high quality product. Lead and develop the organization by example.

Responsibilities: Essential Duties

• Supervise and/or oversee all personnel in the unit for proper application of company policies and procedures and on the job performance.

• Partner with various internal resources to establish a sustainable and profitable business model. This includes product, facilities, equipment, maintenance, spare parts, supply chain, services, staffing, operating procedures, policies and standards.

• Manage to short and long term goals (via Strategic Planning to include Value Stream Planning) to reduce costs, eliminate waste, increase efficiencies and improve processes to achieve product quality, customer satisfaction and cost key performance indicators.

• Monitor and confirm organizational adherence to policies, procedures, regulations (product quality and employee safety and standard work).

• Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures.

• Responsible to review and approve quality investigations to ensure documentation is complete, accurate and timely.

• Drive and support implementation of major cost savings and continuous improvement projects to include participation in Kaizen events including employee suggestions.

• Ensure the effective use of human, physical and financial resources in order to achieve company objectives.

• Accountable for hiring, personnel development, salary administration and performance evaluation of assigned employees.

• Provide performance appraisal, employee coaching and counseling. Resolve conflicts and implement disciplinary action when necessary.

• Responsible for efficient and compliant flow of product, personnel, materials/supplies and rejected product/materials.

• Communicates effectively to all levels of the organization using all forms of communication.

• Drives effective and timely problem solving through effective employee engagement use of resources and Lean/Quality tools.

• Responsible for developing, monitoring and achieving budgetary goals.

• Creates and delivers presentations to all levels of the organization.

• Ensure that all areas and equipment are maintained to meet Pharmaceutical Elegance standards.

Expertise: Knowledge & Skills

• Company policies and procedures, GMP, FDA and OSHA regulations.

• World Class Manufacturing principles.

• Computer applications programs, Maintenance Planning, Quality Control, Process Improvements, Employee Relations, Technical Expertise and good knowledge of engineering principles.

• Ability to read and interpret technical drawings, schematics and documents.

• Excellent verbal and written communication skills.

• Leadership and training ability.

• Employee relations expertise.

• Troubleshooting skills.

• Time and project management skills.


Expertise: Qualifications - Experience/Training/Education/Etc


• BS/BA degree with 8 years experience in an Engineering and/or manufacturing position where at least part of it was gained in a FDA/GMP regulated environment.

• Engineering, Quality and/or manufacturing experience in the pharmaceutical, chemical, food, beverage, aerospace, electronics, consumer goods industry, or equivalent.

• Successful completion of Lean Professional Certification, 6 Sigma Black Belt or structured development plan for same; working knowledge of Operational Excellence to include application of Lean and /or 6 Sigma tools.

• Advanced computer skills


Strong manufacturing background with automated equipment in addition to manual processes