West Pharma Quality Assurance Manager 

United States, Nebraska 

938252241

Job Summary:

Assure compliance of the plant processes and products to established industry standards, specifications, and procedures, ensure quality system is implemented and its integrity maintained.

Essential Duties and Responsibilities:

• Directs and manages quality control, quality systems, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible.
• Manage and maintain an effective Quality Assurance program for the plant in alignment with Global Operating Procedures and capable of maintaining ISO 9001 and 15378 certification status.
• Review operating procedures to ensure compliance with all related procedures, instructions and the Quality Manual.
• Establish procedures and methods to comply with applicable GMP, ISO requirements and customer expectations
• Ensures timely resolution to customer inquiries (audit findings and complaints)
• Review customer requirements and make sure the system is in place to meet them
• Investigate and ensure implementation of the corrective actions associated with non-conformances, including, customer audits and complaint reports
• Achieves quality operational objectives by contributing information and analysis to strategic plans and reviews.
• Conduct routine quality project management reviews with project Teams and management
• Drive continuous quality improvement projects at plant based on site data and customer expectations
• Drive compliance to global harmonization initiatives
• Conduct plant Quality Management Review meetings of the plant quality system
• Establish and monitor plant Quality Metrics used to evaluate the effectiveness of the Quality System
• Manage Quality Staff at site to assure knowledge and execution of site Quality System
• Assure proper use of change management associated with validated processes
• Assure execution of internal audit program
• Adjust in process/final sampling plans & related accept/reject criteria to ensure compliance to specification and customer requirements
• Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
• Drive continuous quality improvement projects and global harmonization initiatives
• Utilize PMI strategies and techniques to manage Scope, Time, and Budget.
• Maintain clear communication paths with stakeholders
• Identifies and determines quality improvement
• Maintain clear communication paths with stakeholders
• Performs other duties as assigned based on business needs

Education:

• Bachelor's in Science or Engineering, or commensurate experience

Experience:

• 6-10 years of experience in Quality Assurance / Quality Control / Quality System

Preferred Knowledge, Skills and Abilities:

• Superior organizational and leadership skills with ability to help team grow and thrive
• Experience with Customer interface and meeting customer expectations.
• Demonstrate team building and problem-solving skills
• Ability to effectively prioritize and escalate issues
• Working familiarity with Project Management Tools and Quality Risk Management.
• Working knowledge of ISO requirements (15378) and Pharmaceutical Industry requirements (cGMP, etc)

Travel Requirements:

• Minimal Travel for customer interface

Physical & Mental Requirements:

• Work in a manufacturing environment, subject to heat and cold as well as loud noise.
• Work in an office environment. At times must sit for extended periods of time.
• Ability to effectively communicate and comprehend complex ideas and concepts.