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Senior QC IT System Analyst

Category: IT

FUJIFILM Diosynth Biotechnologies

We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines.

With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility.

Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together.

About Us

As a QC IT application system manager you will be responsible for operations and maintenance of the systems in your domain particularly Labware LIMS and Empower. Your key objective will be to continuously improve business operations and to ensure compliance/alignment between the different requirements at different levels and from different stakeholders of the organization.

You will be the lead site contact to the vendors and responsible for coordinating all updates to the systems, report and track technical issues, proactively manage licenses of the systems.

You will be responsible for second level support of the system, maintain a knowledge base for first level support as well as promote best practices in the applications utilization.

Role & Responsibilities

The role also includes smaller project management tasks, like driving upgrade projects and secure operation management is considered, participate as a technical lead in Global IT and compliance projects, initiate and drive own optimization projects, in cooperation with vendor if required.

The role supports the maintaining of the validated state of the systems throughout the life cycle. This role requires developing and documenting the specialist technical knowledge and transferring technical knowledge to peers and the business.

What you will do:

Provision of timely and effective support to ensure the satisfaction of internal customers. Understand and anticipate the needs to enhance the quality-of-service delivery. (10%)
Responsible for ensuring the reliability, availability, and security of systems/technologies under your management. Keeping up to date with technological advancements and implementing system and process improvements in your area. (10%)
Adherence to ITIL or relevant IT service management (ITSM) frameworks is expected, along with the responsibility for documenting and refining IT processes to increase operational efficiency and effectiveness. (15%)
Compile technology related documentation for GxP and critical IT technologies. Participate in system validation and testing processes as required. Approve validation documentation together with relevant IT QMS documentation (10%)
Manage or contribute to IT projects, ensuring they meet deadlines and stay within budget. Employing best practices in project management (10%)
Establishing and maintaining relationships with technology vendors and service providers. Managing vendor performance to ensure the company receives value from them. (10%)
Oversee day-to-day operations, providing guidance and support to up to 3 direct reports. (10%)
Foster a collaborative and high-performance culture within the team. (10%)
Establish key performance indicators (KPIs) to measure success and drive continuous improvement. (5%)
Provide regular reports and updates to senior management. (5%)
All other duties as assigned, including but not limited to, supporting and administering any applications that are added to the Technical Operations QC IT group portfolio. (5%)

Qualifications and Experience

What you will need:

Bachelor's degree in a related discipline (IT or Computer Science) is required.
5+ years of experience in the IT field and/or pharmaceutical industry with knowledge of Computer Systems Validation.
5+ years of relevant experience, demonstrating strong leadership capabilities in managing teams and projects.
Proven experience designing, installing, and testing IT systems.
Proven experience administering Labware LIMS and Empower applications.
Pharmaceutical experience is required.
Proven experience working and/or managing IT projects.

Preferred for the role:

Additional certifications relevant to the role are desirable (e.g., Labware LIMS or Waters Empower Administration course completion).
Experience working in QC and QA processes is an advantage.

Who you are:

The ideal candidate has a collaborative attitude with the willingness to work with global peers and cross-functional teams toward Company and department goals. You can prioritize and work autonomously based on common goals and objectives. You have a strong analytical mind, eye for detail, and problem-solving skills. You have a natural drive for simplification and a quality mindset. You are willing to learn new things and drive solutions.

Knowledge, Skills and Abilities:

Excellent oral and written communications skills and fluency in English
Strong analytical skills
High sense of responsibility.
Working knowledge of software maintenance in a regulated environment. Documented ISO and cGMP understanding and knowledge of GAMP

Why work with us?

When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition to this, we offer: