Description
This is a hybrid position requiring the team member to be onsite a minimum of 4 days per week.
Who We Are
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
Manage the day-to-day planning and supervision of quality systems activities including quality systems availability, audit management, customer feedback and enterprise management system quality master data. Ensure continuous improvement of processes to ensure quality product and customer service. Representative for Global systems projects and systems upgrades
Essential Duties And Responsibilities
* Site QA Manager designee for QA Systems and customer engagement activities.
* Customer and Regulatory audit support
* Hosting Audits
* Prioritize & manage available QA systems resources to ensure on time scheduling and response timelines are achieved for customer audits, notifications responses, management reviews, and customer complaints
* Ensure Waterford are represented in Global Quality System Project deployment to ensure compliance to standards and efficiency in doing business.
* Prioritize & manage available QA systems resources to ensure schedule adherence for quality reporting.
* Prioritize & manage available QA operations resources to ensure schedule adherence for master data creation for technical transfer & new product introduction activities.
* Monitoring of trends in association of quality systems use and effectivity (Deviation, CAPA, Change Control, Periodic Documentation Review etc.)
* Ensure GMP training of site personnel in relation to systems use and audit practises.
* Perform QA Sys Engineer tasks as required.
* Identify and develop opportunities to improve existing processes and procedures in line with corporate and customer requirements.
* Ensures compliance with Customer Agreements and Specifications, Applicable ISO standards and regulations.
* Endorses an "Audit Ready Every day" and Customer Focussed Culture
* Perform routine visual inspection of work areas for unusual occurrences, safety hazards, housekeeping, work space organization and control.
* Monthly and quarterly reporting of Quality Key Performance Indicators (KPI's)
* Interface with other West sites with respect to sharing of best practices.
* Lead in the continuous improvement of Xs processes- playing an active and key role supporting the team in continuous improvement initiatives/projects.
* Responsible for the execution of training for the team; identification of training requirements for the team.
* Own the development process for each team member. Delegation of development objectives and activities Assigning tasks, reviewing work and completion of appraisals in line with the company targets.
* Manage the team's performance, conduct performance 1 to 1's, support recruitment, training and development plans while addressing any issues that arise in a timely manner.
* Maintain a positive employee relations atmosphere. Ensure that there is good communication and co-operation by encouraging knowledge sharing.
Additional Responsibilities
* Ensure adherence to corporate Quality System requirements
*Education*
* Bachelor's Degree in Quality/ Engineering/Science or business systems.
*Work Experience*
* Minimum 5 years' experience preferably in a high volume GMP environment in a Quality Assurance/Quality System function.
* Must have a thorough understanding of ISO 9001 and/or ISO 15378, ISO 13485, cGMP quality management processes
* Customer feedback and audit management experience
* Must have thorough understanding of enterprise and document management system requirements.
* Prior Supervisory experience is an advantage
Preferred Knowledge, Skills And Abilities
* Lean/Six Sigma principles
* Leading & Managing Others
* Audit Management
* Quality Risk based thinking and decision making.
* Natural ability to work in team oriented environment
* Must have excellent communication skills both oral and written.
* Must be able to prioritize and organize tasks using shared systems.
* Regulatory training is an advantage.
* Problem solving including root cause failure analysis methods
* Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
* Able to comply with the company's safety policy at all times
* Knowledge of cGMP, cGDP
*Travel Requirements*
5%: Up to 13 business days per year
*Physical Requirements*
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
*What We Offer*
Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.
Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.
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. 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.