Head of Global Quality Compliance and Audit Management, APAC
Today, Lonza is a global leader in life sciences operating across three 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.
Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.
Due to business growth, we are recruiting a Head of Global Quality Compliance & Audit Management APAC. The role 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. Role will lead and manage the regional Global Quality Compliance and Audit management team. Develop, plan and execute a program of corporate Quality/GMP compliance audits/assessments for Lonza’s 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 but also covering food, feed and cosmetic ingredients and dietary supplements. The role will advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements. Advise, guide and support sites in the overall regulatory inspection management. Provide expertise to sites and the global organization on GMP compliance and best practices as well as new and developing GMP regulatory requirements and trends. Additionally, the role will be assessing the quality of the Suppliers and their ability to meet defined requirements thus supporting the uninterrupted supply of materials and services to Lonza within area of responsibility.
- Leads and manages the APAC Quality Compliance and Audit Management Team:
- Lead a team of Quality Compliance and Audit Management experts: hiring and developing top talent to create a high performing team and succession pipelining.
- Ensure active training and development plans with the objective of driving the overall competence and professionalism of the group
- Is an inclusive Leader
- Global Quality Compliance Internal Audit/Assessment Management:
- Review, approval and executing of the audit plan based on risk, taking into account current regulatory focus and business needs.
- Ensure 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
- Ensure timely, detailed and technically correct reports following assessments/audits with appropriate references cited against each observation
- Escalate and communicate identified deficiencies and compliance risks to appropriate business, operations and quality heads
- 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 give support in all compliance matters.
- Develop and ensure the corporate internal audit/assessment documentation and follow-up/tracking system where applicable.
- Regulatory Inspection Management:
- Ensure performance of pre-approval/pre-submission product reviews (e.g. products, facilities), “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.
- In cooperation with other relevant functions and departments, provide advice and on-site support to sites during regulatory inspection.
- In cooperation with other Global Quality functions, review and provide input to commitments made to regulators following regulatory inspections.
- Develop, maintain and manage a global platform for the follow-up of Regulatory Inspection Deficiencies and “lessons learned” observations to ensure such information is communicated, tracked and responded to accordingly by all GMP sites.
- Ensure tracker for inspection management is current
- Supplier Audit/Assessment Management:
- Review, approval and executing audit plans based on risk, taking into account current regulatory focus and business needs.
- Ensure 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
- Ensure adherence to planning of supplier audits/assessments by direct reports.
- Ensure timely, detailed and technically correct reports following assessments/audits
- Communicate identified deficiencies and compliance risks to management
- Ensure fitness of proposed CAPA/ remediation plans
- Ensure completion and maintenance 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:
- Represent Global Quality Compliance in the Global Quality Council on behalf of management
- Represent Global Quality Compliance in Quality Escalation meeting
- Compliance representative for Sr. management reviews for submission and inspection readiness
- Responsible to communicate GMP compliance risks to senior management and across sites. Support in collaboration with Operational Team regular analysis of regulatory observations made at sites and ensure preparation, roll-out and participation of the global follow-up/gap analysis to prevent re-occurrence and provide advice to the sites.
- Provide expertise to sites and the organization on new and developing GMP regulatory requirements and trends, to help ensure the company remains up-to-date with current GMP expectations
- Enforce continuous improvement and reporting , reviewing and trending GMP Compliance risks on a global basis as well as Lonza external GMP risks and trends
- Quality/Compliance projects and standards:
- Participate in or lead agreed Quality/Compliance projects, aligned with the company strategy and group objectives e.g. Quality/Compliance Task Forces, remediation projects
- Ensure Quality/Compliance representative in Due Diligence projects
- Ensure development and maintenance of SOPs for the Global GMP Compliance processes
- Develop and maintain CORP and GROUP Quality standards and processes based on personnel and group expertise and assigned areas
- Fulfil role as a technical reviewer and approver of CORP and GROUP Quality/GMP procedures and policies.
- Bachelor's degree in a scientific field or equivalent.
- Strong leadership capabilities
- Extensive years of experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area with experience in Quality, Compliance.
- Profound knowledge in cGMPs and cGDP requirements and understanding of the regulatory process and requirements
- Proven track record with FDA, EMEA and other Health Authorities
- Extensive auditing experience in GMP regulated environments, with experience specifically in some/all of:-cell and gene therapy, aseptic product, biologics and medical device manufacture
- Experience in Supplier Qualification and Supplier Monitoring
- Strong understanding of risk assessment and risk management fundamentals/tools
- Proven management skills with the ability to lead and mentor others effectively and experience with advocating for a compliant environment
- Ability to work in a collaborative team environment is essential, with a customer focused approach
- Strong decision maker with the ability to utilize critical thinking to problem-solve
- Must have strong interpersonal and communication skills
- Traveling across the region is required as part of the role.
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.