Quality Systems Manager

Description

This is an onsite position requiring the team member to be onsite 5 days a week.

No relocation is provided for this opportunity.

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.

The 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.

• 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

• Bachelor's Degree in a technical discipline to include;
  Science, Quality or Engineering or equivalent 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, ISO
  13485, 21
  
  CFR Part 820 QMSR.
• Experience developing and maintaining a QMS supporting EU and US markets and hosting customer, corporate and regulatory audits or inspections.
• Proven…