Global Associate Director, Quality Compliance

Lonza; Tampa (FL); Remote; USD 120,000 - 160,000; Full time

Job summary

Lonza seeks a Global Associate Director, Quality Compliance to oversee GMP compliance audits across its manufacturing sites. This role involves advising on compliance, managing regulatory inspections, and ensuring supplier quality. The ideal candidate will have extensive experience in GMP environments and a Master's in Life Sciences.

Qualifications

• Extensive auditing experience in GMP regulated environments.
• Knowledge of cGMPs and regulatory processes.

Responsibilities

• Develop and execute corporate GMP compliance audits.
• Advise sites on compliance and remediation actions.
• Manage supplier quality assessments and audits.

Skills

Risk Management

Auditing

GMP Compliance

Education

Master's Degree in Life Sciences

Job description

Today, Lonza is a global leader in life sciences 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.

Job Summary:

The Global Associate Director, Quality Compliance supports the overall Lonza strategy to gain and maintain the license to operate. This is achieved by lowering the quality and compliance risk through audits, advising the sites to reach an optimum state of compliance. Develop, plan and execute a program of corporate GMP compliance audits/assessments for Lonza’s manufacturing sites and operations with a focus on sterile and non-sterile drug products (including solid dosage forms, biologics, cell/gene therapy), biological and chemical APIs, medical devices and excipients. This also covers food, feed and dietary supplements and sites involved in software and hardware manufacture. Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements. Advise, guide and lead the support for sites in the preparation for, and overallmanagement of, regulatory inspections. Provide expertise to sites and the global organization on all aspects of GMP compliance and best practices, as well as new and developing GMP regulatory requirements and trends. Perform Supplier Quality assessments / audits of Suppliers and Contractors to the annual plan and follow up on agreed upon CAPAs. Ensure the uninterrupted supply of materials and services to Lonza within area of responsibility by assessing the quality of the Suppliers and their ability to meet defined requirements utilizing tools such as Quality Risk Management (QRM), supplierassessment/audit, change management, and complaint/deviation trend management. May act as Single Point of Contact / SPOC for assigned suppliers from a global portfolio on behalf of Head of Global Quality Compliance and Audit Management EU or APAC or US.

This position can be remote 100% for the right candidate with the expectation that the employee may be expected to periodically go to Portsmouth, NH.

Key Responsibilities:

Global Quality Compliance Internal Audit/Assessment Management

• Develop audit plans based on risk, taking into account current regulatory focus and business needs

• Develop audit agendas based on risk assessment principles drawing on previous audits, current regulatory trends, applicable regulations, any imminent customer submissions and stakeholder input

• Execute Global Quality/GMP compliance audits/assessments as lead- or co-auditor for any internal sites associated with any risk level (high, medium, low)

• Produce timely, detailed and technically correct reports following assessments/audits with appropriate references cited against each observation

• Escalate identified deficiencies and compliance risks to appropriate business, operations and quality heads and, if appropriate, feed into the Operations team for inclusion into Gap Analysis

• Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements. Approve proposed CAPA/ remediation plans, regularly review progress & effectiveness, and continue to givesupport in all compliance matters

• Complete and maintain the corporate internal audit/assessment documentation and follow-up/tracking system where applicable.

• Provide advice, guidance and support to sites for 3rd party audits (e.g. GMPs and ISO 9001)

Regulatory Inspection Management

• Support pre-approval/pre-submission project reviews, “mock” inspections as part of the Global Compliance Assessment program. Provide guidance for timely remediation

• Advise, guide and lead the support for sites in their overall regulatory inspection management

• Provide advice and on-site support to sites during regulatory inspections

• In cooperation with other Global Quality functions, review and provide input to commitments made to regulators following regulatory inspections

Supplier Audit/Assessment Management

• Develop audit plans based on risk, taking into account current regulatory focus and business needs

• Develop audit agendas based on risk assessment principles drawing on previous audits, current regulatory trends, the required scope of the audit, applicable regulations, and stakeholder input

• Execute supplier audits/assessments as lead or co-auditor

• Produce timely, detailed and technically correct reports following assessments/audits

• Communicate identified deficiencies and compliance risks to the Head of Global Compliance EU or APAC or US

• Ensure fitness of proposed CAPA/ remediation plans

• Complete and maintain the audit/assessment documentation and follow-up/tracking system where applicable

• Participate in the Reporting on QA Supplier performance in support to the QA operations Team- this is to include Risk Assessment ranking and managing of defined KPI’s

Quality Compliance Risk Management

• Support the site QA Operations teams in the regular analysis of regulatory observations made at Lonza’s sites to prevent re-occurrence and provide advice to the sites

• Provide expertise to sites and the organization on new and developing regulatory requirements and trends, to help ensure the company remains up-to-date with current GMP expectations (including Regulatory Intelligence Bulletin Process)

• Support the site QA operations teams in the continuous improvement and maintenance of global platforms for reporting, reviewing and trending Quality/GMP Compliance risks on a global basis within Lonza (e.g. Compliance Risk Tool) as well as Lonza external GMP risks and trends (e.g. WL/SNC reviews)

Quality/Compliance projects and standards

• Participate in or lead agreed Quality/Compliance projects aligned with the company strategy and group objectives

• Fulfill role as a technical reviewer and approver of CORP and GROUP Quality/GMP procedures and policies

• Develop and maintain CORP and GROUP Quality standards and processes based on expertise and assigned areas in collaboration with Operational Team

Other activities

• Ensure expertise in GMP is kept current through involvement in Industry forums and conferences.

• Provide assistance to sites on an as needed basis

Collaboration/stakeholders management/Leadership

• As a senior member of the Global Compliance team, support the onboarding of new team members and the qualification of new auditors and assessment of existing auditors

• Provide training and mentorship to less experienced members of the team

• Provide constructive feedback to peers and manager to promote quality culture

• Demonstrate the Lonza Quality Behaviors

• Foster inclusive leadership

Key Requirements:

• Master's Degree in Life Sciences is preferred; a combination of education and years of experience will be considered

• Profound knowledge in cGMPs and cGDP requirements and understanding of regulatory process and requirements

• Proven track record with FDA, EMEA and other Health Authorities

• Extensive auditing experience in a GMP regulated environment, with experience specifically in some/all of: cell and gene therapy, aseptic product, biologics, food, feed, dietary supplements, software, hardware and medical device manufacture

• Experience in Supplier Qualification and Supplier Monitoring

• Strong understanding of risk assessment and risk management fundamentals/tools

• Training or knowledge in the EU Qualified Person/Swiss Fachtechnisch verantwortliche Person responsibilities

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.