QA Specialist
7 days ago
United States, Portsmouth (New Hampshire)
Today, Lonza is one of the world's largest healthcare manufacturing organizations operating across five continents.' While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
The QA Manager, Inspections and Audit Management manages a team of Compliance Specialists/Project Managers and is responsible for coordinating and completing the internal audit, customer audit and regulatory agency inspection programs. Works closely with site leadership and customers to implement effective corrective and preventive actions in response to deficiencies. The manager assigns the resources and priorities for the team, ensures adequate training, coaches and develops staff, and evaluates performance.
Location: Portsmouth, NH
Key Responsibilities:
* Responsible for the internal audits and customer audits programs at the site, ensuring that the audit team has the appropriate knowledge, education and experience to be able to handle the schedule, perform internal audits, and identify significant issues through mentor and training opportunities to the team and the site readiness for inspection.
* Coordinates and supports execution of responses to customer audits and inspections.
* Owns the regulatory agency inspection program for the site, ensuring readiness for routine GMP inspections and pre-approval inspections through an effective internal audit program, ongoing inspection preparation, close coordination with customers and internal project teams.
* Runs inspection logistics and communications to the site, corporate management and customers.
* Works with senior quality and site leadership to identify and implement remediation in a timely manner.
* Provides general direction and support and acts as a point of escalation for QA staff and customers. Supports the flow of tasks as needed to ensure deliverables are met.
* Member of site Quality Council providing updates on audit program metrics, improvements, issues and endorsements. Also attends CAPA board meetings.
* Maintains metrics relevant to Inspection and Audit Management program, supervises performance and ensures continuous improvement through collaboration with stakeholders, promoting GMP compliance, customer satisfaction and a strong culture of quality awareness.
* Performs other duties as assigned.
* This position requires management of direct reports.
Key Requirements:
* Bachelor's degree in a relevant field. Regulatory Affairs preferred.
* Minimum 5-10+ years of experience of customer and regulatory auditing experience within FDA regulated industries.
* Advanced knowledge of relevant GMP regulations: FDA 21 CFR 11, EMA, ICH, and other relevant regulations and standards.
* Excellent communication skills
* Strong interpersonal skills to interact with clients, team members, and regulatory agencies
Additional preferred skills:
* Experience with TrackWise and Microsoft Suite
* Solid understanding of ERP Systems and Quality Management Systems
* Detail-oriented and organized
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Reference: R63414
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