Director of Quality

Director of QualityThis is a hybrid position requiring the team member to be onsite a minimum of 3 days per weekWho 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: The Director, Quality Assurance serves as an Operating Unit–level Quality Transformation leader for the Drug Delivery Devices portfolio. Reporting to the Senior Director of Quality, this role is accountable for driving cross-site harmonization and operational excellence across three manufacturing sites, with explicit governance responsibility for change control and document management processes. This position leads multi-site process improvement initiatives focused on simplifying workflows, reducing cycle times, and standardizing best-in-class quality practices. The Director is responsible for defining and institutionalizing Operating Unit–level quality governance standards, partnering closely with site Quality leaders to implement harmonized processes while respecting site-specific operational needs. In addition, this role owns Operating Unit quality metrics governance and modernization. The Director will streamline KPI reporting, transition manual reporting structures to automated and scalable solutions, and provide executive-level visibility into quality performance trends and risk indicators. Externally, the Director serves as the primary quality interface for key pharmaceutical customers within the Operating Unit. This includes leading quality discussions during business reviews, proactively communicating performance insights, and strengthening customer confidence through transparent and data-driven engagement. This role operates in a matrix environment, influencing site Quality teams and cross-functional stakeholders without direct reports. The position requires strong executive presence, enterprise-level thinking, and a demonstrated ability to drive measurable quality transformation across complex, multi-site environments.Essential Duties and Responsibilities:Operating Unit Quality Governance & HarmonizationMulti-Site Quality Transformation & Operational ExcellenceQuality Metrics Governance & ModernizationExecutive Customer Quality LeadershipEducation: Bachelor's Degree in Science, Engineering, or related field requiredWork Experience: Minimum 10 years of progressive Quality experience in FDA-regulated medical device or combination product environments. Demonstrated experience leading cross-site or multi-site quality initiatives. Experience governing or improving core Quality System processes (e.g., change control, document management, lifecycle processes). Experience operating effectively in a matrix environment without direct authority. Experience interfacing with external customers on quality-related matters.Preferred Knowledge, Skills and Abilities: Deep knowledge of core Quality System processes within FDA-regulated medical device or combination product environments, including change control, document management, CAPA, and risk management principles. Strong understanding of applicable global medical device regulations and standards (e.g., 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR), with the ability to translate regulatory expectations into practical and scalable quality processes. Demonstrated ability to design, standardize, and harmonize quality processes across multiple manufacturing sites. Practical experience applying Lean, Six Sigma, or other continuous improvement methodologies to reduce cycle times and improve process transparency. Strong analytical capability, including development and governance of quality KPIs and performance dashboards. Experience modernizing reporting structures and supporting automation of quality data tracking and visualization tools. Ability to operate effectively in a matrixed and geographically diverse organization, influencing without direct authority. Executive-level verbal and written communication skills, with the ability to present complex quality information clearly to senior leadership and external customers. Strong business acumen with the ability to balance compliance requirements, operational efficiency, and customer expectations. High degree of ownership, accountability, and strategic thinking. Strong organizational and follow-through skills with the ability to manage multiple cross-site initiatives concurrently.Travel Requirements: 20%: Up to 52 business days per yearPhysical 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. Additional Requirements Position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Some of the work will require exposure to loud noises if in the plant facility. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger and reach with hands and arms. 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 View email address on click.appcast.io. 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.