Lonza America Inc
Manager, Inspection and Audit Management
Lonza America Inc, PORTSMOUTH, NH
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 leads a team of Compliance Specialists/Project Managers and is responsible for implementing and executing the internal audit, customer audit and regulatory inspection programs. Ensures that site management is provided current assessments of the status of the Quality System, and that compliance risks are communicated in a timely manner. 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. . This position supports the overflow of tasks as needed to ensure deliverables are met. Responsible for actively pursuing opportunities for improvement and promoting a strong culture of quality awareness and GMP compliance.
Key Responsibilities:
• Leads the internal audit program. Develops the internal audit schedule, taking into account potential compliance risks.
• Oversees internal audits, ensuring that the audit team has the appropriate knowledge, education and experience to be able to identify significant issues through coaching and educational opportunities.
• Leads the customer audit program.
• Works with customers to schedule audits, ensuring that requirements defined in Quality Agreements are upheld.
• Responsible for supporting execution of and response to customer audits. • Leads the regulatory inspection program.
• Ensures readiness for routine GMP inspections and pre-approval inspections through an effective internal audit program and ongoing inspection preparation. • Ensures readiness for pre-approval inspections through close coordination with customers and internal project teams.
• Manages inspection logistics and communications to the site, corporate management and customers.
• Hosts Regulatory inspections and authors/oversees responses to Regulatory bodies.
• Works with 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.
• Attends Site Quality Council and attends/co-chairs CAPA board meetings.
• Maintains metrics relevant to Inspection and Audit Management function.
• Leads the hiring process and ensures department is staffed per budget.
• Provides direction for department staff. Develops team goals, monitors progress and ensures continuous improvement.
• Conducts regularly scheduled 1 on 1 meetings with staff, provides performance feedback, coaches, mentors and supports career development.
• Performs other duties as assigned.
Key Requirements:
Bachelor's degree
Minimum 5-10+ years' experience advancing knowledge of relevant GMP regulations: FDA 21 CFR 11, EMA, ICH
Additional preferred skills:
• Experience with TrackWise, SAP, Syncade and Microsoft Suite
• Detail-oriented
• Organized
• Self-motivated
• Quality decision making
• Excellent inter-personal skills
• Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities
• Attention to detail, works effectively individually and with teams
• Positive attitude, customer focused, works well under pressure, confident making quality decisions, and able to motivate others.
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
The QA Manager, Inspections and Audit Management leads a team of Compliance Specialists/Project Managers and is responsible for implementing and executing the internal audit, customer audit and regulatory inspection programs. Ensures that site management is provided current assessments of the status of the Quality System, and that compliance risks are communicated in a timely manner. 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. . This position supports the overflow of tasks as needed to ensure deliverables are met. Responsible for actively pursuing opportunities for improvement and promoting a strong culture of quality awareness and GMP compliance.
Key Responsibilities:
• Leads the internal audit program. Develops the internal audit schedule, taking into account potential compliance risks.
• Oversees internal audits, ensuring that the audit team has the appropriate knowledge, education and experience to be able to identify significant issues through coaching and educational opportunities.
• Leads the customer audit program.
• Works with customers to schedule audits, ensuring that requirements defined in Quality Agreements are upheld.
• Responsible for supporting execution of and response to customer audits. • Leads the regulatory inspection program.
• Ensures readiness for routine GMP inspections and pre-approval inspections through an effective internal audit program and ongoing inspection preparation. • Ensures readiness for pre-approval inspections through close coordination with customers and internal project teams.
• Manages inspection logistics and communications to the site, corporate management and customers.
• Hosts Regulatory inspections and authors/oversees responses to Regulatory bodies.
• Works with 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.
• Attends Site Quality Council and attends/co-chairs CAPA board meetings.
• Maintains metrics relevant to Inspection and Audit Management function.
• Leads the hiring process and ensures department is staffed per budget.
• Provides direction for department staff. Develops team goals, monitors progress and ensures continuous improvement.
• Conducts regularly scheduled 1 on 1 meetings with staff, provides performance feedback, coaches, mentors and supports career development.
• Performs other duties as assigned.
Key Requirements:
Bachelor's degree
Minimum 5-10+ years' experience advancing knowledge of relevant GMP regulations: FDA 21 CFR 11, EMA, ICH
Additional preferred skills:
• Experience with TrackWise, SAP, Syncade and Microsoft Suite
• Detail-oriented
• Organized
• Self-motivated
• Quality decision making
• Excellent inter-personal skills
• Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities
• Attention to detail, works effectively individually and with teams
• Positive attitude, customer focused, works well under pressure, confident making quality decisions, and able to motivate others.
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