Executive Director, Global Head of Quality Operations

vor 5 Monaten

Basel, Schweiz Lonza Vollzeit

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.

We are looking for a Global Head of Quality Operations, Biologics responsible for providing technical Quality/Regulatory-related expertise and Quality Operational Management oversight to the Biologics site network.

This role is responsible for supporting the development and driving the execution of the Biologics Quality strategy commensurate with the overall Quality plan of the company.

The incumbent will ensure alignment with customer needs and linkage with the overall Quality and business unit strategies, as well as implement and monitor Quality programs, policies and procedures to ensure compliance with GxP standards, corporate policies, FDA and other regulatory body guidelines.

The Global Head of Quality Operations, Biologics will serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction.

This role will also support the site network with all partner and regulatory authority audits and inspections and/or critical investigations, overseeing corrective action programs in response thereto.

Join us today and apply for this exciting opportunity at Lonza.

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 with the objective of driving the 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, delivers improved business performance against critical quality factors. Detects potential gaps and initiates corrective and preventive actions (continuous improvement)

Oversees the trainings of overall quality specifications and standards. Works 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 the Biologics sites and their teams for 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 the 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 - 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, and have 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 system

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.

Reference: R61747

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