Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World.
At West, we are by the side of patients. The work we do impacts patients' lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $1.84B in 2019. We serve by the side of our community. Giving back is in our DNA-our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West with Without Borders team member-led giving program.
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.
- 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
- 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 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
- Identifies and determines quality improvement
- Maintain clear communication paths with stakeholders
- Performs other duties as assigned based on business needs
- 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)
Preferred Knowledge, Skills and Abilities:
Education: Bachelor's in...
- Science or Engineering, or commensurate experience
Experience: 6-10 years of experience in...
- Minimum six (6) years in Quality Assurance / Quality Control / Quality System
- 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.
- 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 disability or special need that requires accommodation, please send an email to ...@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.
Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task