This is an onsite position requiring the team member to be onsite 5 days a week.No relocation is provided for this opportunity.Job SummaryThe Quality Systems Manager leads the governance, compliance and continual improvement of the Quality Management System (QMS) for West, Indiana. The role ensures the QMS remains effective, inspection-ready and compliant with applicable drug product, medical device, combination product, customer and West requirements. The position leads the Quality Systems team and is responsible for Quality Systems, regulatory readiness, supplier quality governance, risk management and continuous improvement. The Quality Systems Manager reports into the Site Quality Director.
Essential Duties and Responsibilities- Lead, develop and coach the Quality Systems team through effective performance management, succession planning and capability development.
- Own the site QMS, ensuring effective governance, compliance, process ownership, performance monitoring and continual improvement.
- Oversee deviations and non-conformances, CAPA, change control, complaints, document control, training, Management Review, Product Quality Review, supplier quality, validation governance and quality risk management.
- Develop and implement the site Quality Systems strategy and roadmap, aligned with regulatory, customer and West requirements.
- Lead sustained audit and inspection readiness and act as the primary Quality Systems representative during customer, corporate, regulatory and Notified Body audits and inspections.
- Provide regulatory compliance leadership, monitor emerging requirements and ensure implementation of required changes, submissions, regulatory commitments and manufacturing authorization requirements.
- Act as the primary liaison with customers, regulatory authorities, the Qualified Person, Corporate Quality and other West sites on Quality Systems and compliance matters.
- Provide Quality Systems oversight of new product introductions, technology transfers, validation programs and operational changes, including the review and approval of Validation Master Plans, validation protocols, reports and associated validation documents, in accordance with the approved site authorization matrix.
- Establish, monitor and report QMS performance through KPIs, trend analysis and Management Review, ensuring timely escalation and resolution of quality risks and adverse trends.
- Drive standardization, risk-based decision-making and continuous improvement through simplification, harmonization, data analysis and adoption of best practices.
- Champion a patient-first and right-first-time quality culture and represent Dublin in enterprise Quality System initiatives and global program deployment.
- Ensure compliance with company policies, Quality and EHS requirements, the Guiding Principles and the Corporate Code of Conduct.
- Perform other duties as assigned
Education- Bachelor's Degree in a technical discipline to include; Science, Quality or Engineering or equivalent experience
Work Experience- Minimum of 8 years of Quality/ Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry.
- Proven experience in Medical Device and Pharmaceutical Packaging and Combination Products regulations e.g., EU GMP, 21 CFR Part 210/211 and Part 4, ISO13485, 21CFR Part 820 QMSR.
- Experience developing and maintaining a QMS supporting EU and US markets and hosting customer, corporate and regulatory audits or inspections.
- Proven general leadership and quality management experience which includes quality execution, analysis and deadline driven.
- Excellent computer skills, experience with MS Office, ERP systems, Statistical software etc.
- Demonstrated experience leading people, Quality Systems, compliance programs or cross-functional quality improvement initiative.
Preferred Knowledge, Skills and Abilities- Working knowledge of applicable EU GMP requirements, ISO 13485, ISO 14971 and US 21 CFR Parts 210, 211, 820 QMSR and Part 4.
- Lead auditor qualification or equivalent audit experience; supplier audit experience is desirable.
- Strong leadership, coaching, stakeholder management, analytical, organizational and communication skills.
- Ability to prepare clear, concise and audit-ready documentation, analyze trends and drive sustainable corrective and preventive action.
- Lean Sigma training, ideally Green Belt level, with experience leading improvement programs.
Additional Requirements- Thrive in a fast-paced environment where teamwork and collaboration drive success.
- Bring a positive, can-do attitude every day as we build and grow together.
- Contribute to ramping up a state-of-the-art manufacturing facility from the ground up.
- Embrace change and innovation as we launch new operations at record speed.
- Work hard, stay flexible, and support your teammates to achieve shared goals.
- Take pride in producing high-quality products that improve patient lives worldwide.
- Live West's core values of integrity, teamwork, and accountability in everything you do.
- Be part of a culture that celebrates learning, problem-solving, and continuous improvement.
- Show initiative and ownership while helping shape a safe, efficient, and high-performing workplace.
- Grow your career and skillset in a dynamic, innovative environment where your contributions truly matter. #LI-JJ1 #LI-ONSITE
Travel Requirements10%: Up to 26 business days per year
Physical RequirementsSedentary-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.
