Title:  Quality Manager -Digital

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 to the development of software and hardware 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 15378 and 13458 certification status.
•    Establish procedures and methods to comply with applicable GMP, ISO requirements and customer expectations
•    Ensures timely resolution to customer inquiries (audit findings and complaints)
•    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
•    Conduct site Quality Management Review meetings of the site quality system
•    Establish and monitor site Quality Metrics used to evaluate the effectiveness of the Quality System
•    Assure proper use of change management associated with validated processes 
•    Assure execution of internal audit program 
•    Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
•    Identifies and determines quality improvement
•    Maintain clear communication paths with stakeholders
•    Performs other duties as assigned based on business needs
•    Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

Basic Qualifications:
•    Experience with computer system Quality (software/hardware/embedded controller).
•    Superior organizational and leadership skills with ability to help team grow and thrive
•    Working knowledge of ISO requirements (15378) and Pharmaceutical Industry requirements (cGMP, etc )
•    Ability to effectively prioritize and escalate issues
•    Education: Requires Bachelor’s degree in science related field, or Information Technology
•    Experience: 8-10 years
•    Direct/Indirect Reports: 2/4

Preferred Knowledge, Skills and Abilities:
•    Demonstrated track record working in a regulated environment such as pharmaceutical or medical device.
•    Working experience with SAP, MasterControl, 
•    CSQE

Travel Requirements:
•    Minimal travel <5%

Physical & Mental Requirements:
•    Use written and oral communication skills
•    Read and interpret data, information and documents
•    Must maintain the ability to work well with others in a variety of situations
•    Must be able to multi-task, work under time constraints, problem solve, and prioritize
•    Ability to make independent and sound judgments
•    Observe and interpret situations, analyze and solve problems

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.