Global Head of Quality Operations
vor 1 Monat
Quality Operations Lead
Lonza is a global leader in life sciences operating across three continents. Our approach to quality is rooted in the belief that talented people working together can devise ideas that help businesses improve lives. To achieve this, we empower our teams to own their careers and drive innovation. We are seeking a Global Head of Quality Operations, Biologics to provide technical Quality/Regulatory-related expertise and Quality Operational Management oversight to our Biologics site network.
This role is responsible for supporting the development and driving the execution of the Biologics Quality strategy, ensuring alignment with customer needs and linkage with the overall Quality and business unit strategies.
The incumbent will implement and monitor Quality programs, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, and other regulatory body guidelines.
This role will serve as the point person with industry partners regarding product quality matters, customer satisfaction levels, and regulatory authority interaction.
Key Responsibilities
- Provides leadership for Quality and Regulatory activities across the Biologics network.
- Plans, directs, and controls all quality requirements and leads a team of DPS Quality Site Heads.
- Hires and develops top talent to create high-performing teams and succession pipelines.
- Ensures active training and development plans for Quality staff to drive overall competence and maturity of the Quality organization.
- First point of contact for the respective Biologics sites for any Quality and Regulatory-related topics.
- Identifies and resolves problems by implementing project-based solutions, delivering improved business performance against critical quality factors.
- Oversees the training of overall quality specifications and standards, working towards a quality-oriented culture across the organization.
- Ensures site alignment with all recognized local and international standards.
- Ensures decisions are fully supported by Lonza Global Quality, as well as local Quality and Regulatory organizations.
- Provides expertise/coaching, assisting Biologics sites and their teams in harmonized implementation of Quality policies, procedures, and specifications.
- Contributes to the development and maintenance of global and local quality systems in line with current regulatory requirements.
- Supports the transition from traditional QA compliance practices towards new frameworks for regulatory oversight of manufacturing quality (cGMP in the 21st century).
- Closely follows industry trends and engages in industry associations to develop innovative future manufacturing concepts (e.g., BPOG, etc.).
- Active member of the Lonza Biologics Quality Leadership Team (BQLT) and the DPS BULT.
Key Requirements
- Master's Degree or equivalent experience in Quality Management or related science discipline.
- Relevant experience in a regulated pharmaceutical industry, including manufacturing, quality assurance, quality control, R&D, and/or drug regulatory affairs.
- Experience of chemical and biological GMP API manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements in a cGMP environment.
- Proven management experience in an EMA/FDA-regulated environment, with an excellent working knowledge of current ICH, PIC/S, EU, and US regulatory requirements and their implementation.
- Leadership role in Operations readiness, including the onboarding and training of new staff – both quality and operations.
- Experience in managing Swissmedic, USFDA, EMA, MHRA Audits, etc.
- Experience hosting and managing inspections and audits.
- Excellent knowledge of computer systems (i.e., Microsoft Word, Excel, PowerPoint, and Visio) with demonstrated skills in the use of information management systems in a GxP environment (TrackWise, DMS, LIMS, SAP, etc.).
- Working knowledge of modern approaches to compliance, such as cGMP in the 21st century.
- Working knowledge of modern quality tools, such as risk-based approaches – FMEA, statistical process control, design of experiments, and Six Sigma.
- Profound working knowledge of cGxP regulations and regulatory trends as they pertain to the stated responsibilities.
- Strong verbal and written communication skills (English and German).
- Ability to communicate quality and compliance requirements to varying levels and functions of the organization.
- Proven ability to lead, mentor, and coach direct reports and teams with or without direct line responsibility.
- Strong organizational skills, ability to balance multiple priorities simultaneously.
- Ability to solve problems, detail-oriented, understands the strategic picture, provides practical solutions. Strong analytical and investigative skills.
- Understands the risk-based approach recommended by Lonza's planning for quality systems.
About Lonza
Lonza's products and services have a positive impact on millions of people. 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. We offer the satisfaction that comes with improving lives all around the world.
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