Head of Digital Systems

Head of Digital Systems (all genders)

PERMANENT CONTRAT

Toulouse, France

Just-Evotec Biologics is seeking a Digital leader who will build the Digital team, culture and systems required to launch, sustain, and grow J.POD Toulouse as a world-class digitally-enabled platform for the development and manufacturing of advanced biopharmaceutical products using Just-Evotec Biologics’ proprietary JP3® process & product design and J.POD® continuous manufacturing process. 

This role requires a collaborative leader who is skilled in building and leading cross-functional teams comprised of staff and contract service providers to install, configure, deploy, start-up, validate and manage the of the full stack of Digital systems required to support product and process development, GMP manufacturing operations and business operations. The role requires a customer-oriented individual who will collaborate with J.POD Toulouse functional heads and other stakeholders to deeply understand their needs, to deliver required Digital initial operational capabilities at plant start-up and to advance Digital maturity over time0 by delivering giant strides in process optimization, manufacturing automation, team productivity, cost savings and value-creating business insights. The successful candidate will be a strategic thinker, a strong communicator, a proven manager of Digital operations in a GMP plant, and a collaborative leader who will drive operational excellence.

Responsibilities

The Head of Digital Systems will:

Lead the installation, configuration, deployment, start-up, validation, day-to-day operations and lifecycle management of the of the full stack of on-premise and cloud-based Digital systems required to perform and support product and process development, GMP manufacturing operations and business operations at J.POD Toulouse

Report to the Just-Evotec VP for Digitization and serve as a member of the Just-Evotec Digital Governance Team. The role will also have operational responsibility to the J.POD Toulouse Site Head/VP for Manufacturing and serve as a member of the J.POD Toulouse Site Leadership Team

Build and lead a high-performing J.POD Toulouse Digital workforce consisting of staff employees, contingent workers, and contract service providers. It is anticipated that certain defined Digital roles (e.g. Process Automation and Computer System Validation) will have line-reporting to the Head for Manufacturing Science and Technology (MSAT) with dotted-line reporting to Head of Digital Systems

Establish and lead the J.POD Toulouse Digital Governance Team consisting of cross-functional stakeholders. Develop a charter with defined roles and responsibilities for the governance of Digital systems at J.POD Toulouse

Represent J.POD Toulouse in the development and implementation of the Just-Evotec Digital Capability Roadmap. In the near term, the J.POD Toulouse section of the Roadmap will focus on finalizing requirements and implementing the Initial Operational Capability (IOC) of J.POD Toulouse Digital Systems needed to start process development and GMP manufacturing operations. Future updates to the Roadmap will involve working with Just-Evotec and J.POD Toulouse stakeholders to gather, prioritize, and sequence requirements for new/enhanced Digital capabilities for a three-year planning horizon, and developing associated budgets and resource plans

Champion a digital-first culture featuring: Customer Centricity, Innovation, Data-driven Decision making, Collaboration, Open Culture, Digital Mindset, Agility and Flexibility

Deliver world-class Digital services with the goal of enabling all functions of J.POD Toulouse to meet mission requirements. Collaboratively develop annual Digital team goals as well as performance standards for day-to-day operations; for each, develop metrics to measure performance. Apply Operational Excellence methods to achieve continuous improvement

Develop and manage the budget for Digital systems, staff and contracted services

Manage all phases of acquisition, configuration, implementation, validation, and lifecycle management of Digital systems

Maintain a real-time inventory of J.POD Toulouse Digital systems, including documentation of user requirements, design specifications, and current configuration, in accordance with company policies, procedures, regulatory requirements and industry best practices

Implement design, configuration, and operational controls to achieve and maintain a continuous state of validation for Digital systems used for GMP operations and to ensure the integrity of data associated with PD and GMP activities in accordance with company policies, procedures, regulatory requirements, and industry best practices

Implement design, configuration, and operational controls to achieve and maintain a strong posture for cybersecurity, as well as a robust incident response capability and business continuity plans, in accordance with company policies, procedures, regulatory requirements and industry best practices

Identify, communicate, and manage risk associated with Digital systems, operations, and projects

Build relationships with internal and external stakeholders to enable successful outcomes for J.POD Toulouse operations

Stay abreast of emerging digital trends and technologies and assess their potential application to enhance J.POD Toulouse competitive advantage

Position Requirements:

Bachelor's degree or higher in a relevant field, such as Computer Science, Engineering or Life Sciences

10+ years of experience in Digital leadership roles at GMP manufacturing facilities

Experience leading large-scale Digital system startup and/or transformation initiatives

Strong business acumen and strategic thinking skills

Excellent communication, collaboration, and interpersonal skills

Ability to influence and drive change at all levels of the organization

Strong project management and organizational skills

Experience leading and managing teams

Knowledge of biologics manufacturing and supply chain operations

Knowledge of emerging digital trends and technologies

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process, and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are currently co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 300 employees is expanding Just's innovative platform and footprint - Opening our first North American J.POD® commercial manufacturing facility in the Seattle area and building our second European J.POD commercial manufacturing facility in the Toulouse France area.

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FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.