Quality Assurance Manager

Quality Assurance Manager

Requisition ID:
67527

Date:
Oct 8, 2024

Location:

Kearney, Nebraska, US

Department:
Quality

Description:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

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

Basic Qualifications:

Education:

Bachelors 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.

#LI-CT1

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.