Senior Associate, Quality Systems

Job Summary

In this role, you will be responsible for supporting the governance, harmonization, and continuous improvement of Quality Management System (QMS) processes across the Vantage manufacturing network. Operating at an above-site level, this role provides oversight of key Vantage OU quality processes including Change Management, CAPA, Global Alerts, Management Review, Quality Metrics, and OU-level Document Control. The role partners with site Quality teams and cross-functional stakeholders to ensure consistent implementation, regulatory compliance, risk-based decision-making, and alignment with West enterprise requirements, customer expectations, and applicable standards including FDA, ISO 13485, EU GMP, and other relevant regulatory requirements. The Senior Quality Specialist – Vantage Operating Unit (OU) reports to the Director, Compliance & Combination Devices.

Essential Duties and Responsibilities

• Manage and coordinate designated Vantage OU QMS processes, including Change Management, CAPA, Global Alerts, Management Review, Quality Metrics, Tier 4 Reporting, and OU-level Document Control.
• Ensure Vantage OU quality processes are standardized, harmonized, effectively deployed, and consistently applied across all Vantage sites.
• Support governance of the Vantage CAPA process, including CAPA Review Board coordination, escalation, prioritization, timeliness, quality, and effectiveness monitoring.
• Drive systemic root cause analysis, cross-site learning, and risk-based corrective and preventive actions across the Vantage network.
• Provide OU-level Change Control oversight to ensure appropriate impact assessment, cross-site alignment, regulatory/customer considerations, and customer notification where required.
• Identify, monitor, and escalate systemic quality risks, adverse trends, and compliance concerns to appropriate stakeholders and senior leadership.
• Support harmonization of site quality systems into standardized Vantage-level processes and promote best-practice sharing across the network.
• Coordinate and manage Vantage OU Management Review, including consolidation, analysis, and presentation of site quality data and executive-level reporting.
• Coordinate weekly Tier 4 quality metric reporting and ensure data integrity, consistency, and accuracy across the Vantage network.
• Support internal and external audit programs, including process/system audits, audit trend monitoring, inspection readiness, and responses to significant findings impacting multiple sites.
• Serve as Quality lead or work package owner on Vantage OU strategic programs and cross-functional initiatives, including product launches, transfers, remediation activities, and other quality-related projects.
• Ensure quality deliverables, compliance milestones, and risk management activities are integrated into project plans and completed on schedule.
• Act as a subject matter expert and mentor for Vantage site Quality teams, supporting capability development and consistent interpretation of QMS requirements.
• Promote a culture of compliance, transparency, continuous improvement, and effective quality decision-making across the Vantage OU.
• Ensure activities are performed in compliance with West corporate policies, applicable regulatory requirements, company guiding principles, and the Code of Conduct; perform additional duties as assigned.

Education

Must have a Batchelor qualification in Engineering/Quality or Science.

Work Experience

5+ years’ experience of working in a high-volume manufacturing environment ideally in the medical device / pharmaceutical sector. A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 QMSR is essential. Must have excellent communication skills both oral and written.

Preferred Knowledge, Skills and Abilities

• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.
• Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 QMSR, 21 CFR Part 4, 21 CFR Part 210/211, EU GMP Volume 4 is preferred.
• Auditing experience to ISO13485, 21 Part 820 QMSR / and EU GMP is considered an advantage.
• A background in drug handling would be considered an advantage.
• Ideally would have experience of third party and regulatory audits and the preparation of same.

Travel Requirements

10%: Up to 26 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.

Additional Requirements

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• Position operates in a professional office environment.
• May stand or sit for extended periods of time
• Able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Maintain the ability to work well with others in a variety of situations
• 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