QC Technical Project Manager in Hatfield

Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas.

Eisai Manufacturing is the hub of Eisai’s production and supply chain.

We make tablets, package these into blisters, label and package vials and bottles.

We also manage the wider medicines supply chain and other companies who undertake work on our behalf.

By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.

Your new role

The Quality Control Technical Project Manager is responsible for the management of all technical projects within the QC laboratory.

This includes leading a team of technical specialists that will manage laboratory electronic systems (e. g.

LIMS and CDS), the introduction and maintenance of new or existing equipment and technologies, and leading laboratory compliance-related activities (e. g. global change, new product introduction, method transfer and pharmacopeia reviews).

The role is responsible for

• Ensuring effective management of a team of technical specialists.
• Ensuring QC Equipment and Electronic Systems are managed effectively to ensure their use in the manufacture, packaging and testing of marketed drug products comply with department Standard Operating Procedures, current GMP, Data Integrity guidelines and Eisai Corporate expectations.
• Creating and maintaining a five-year equipment replacement plan to ensure the QC laboratory is equipped with current equipment and software that meet the testing requirements.
• Ensuring effective management of New Product Introduction and Method Transfer
• Ensuring effective management of QC compliance activities (e. g. global changes and pharmacopeia compliance)
• Ensuring effective management of the education and training of QC team members in the use of specialist equipment and software.
• Reviewing and approving of any associated SOPs and quality policies, as required.
• Leading change management processes to ensure equipment and system data are continuously available and functioning as intended.

What are we looking for?

• Degree or equivalent experience in a science discipline.
• Strong working knowledge of pharmaceutical Quality Control Equipment and Electronic systems, including their qualification and validation.
• Significant previous experience (at least two years) in the technical management of QC Equipment and Electronic Systems.
• Experienced as a laboratory administrator and/or end user of QC electronic systems.
• Excellent communication and good people management skills to support progression of technically led projects internally and externally.
• Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers
• Ability to understand and analyse user requirements to facilitate changes and system improvements
• Good understanding of the requirements of data integrity and application to system management
• Good technical and scientific judgement
• Ability to interpret complex data and present key findings
• Ability to describe technical information in easy-to-understand terms.
• Computer literate e. g. Word, Excel and Power Point
• Thorough understanding of GMP Guidelines and Regulations
• Maintain knowledge and understanding of technical advancements in QC Equipment and Electronic systems

What we offer in return

• Eisai offers a competitive salary and excellent wider benefits package that includes,
• Electric charging points for Electric/Hybrid vehicles
• Discretionary Bonus
• Free onsite parking
• Subsidised onsite restaurant and coffee shop
• Learning and development opportunities
• Well-being & mental health awareness programmes
• Multi-faith prayer room

You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility, which is our EU Headquarters, and offers an inclusive, and collaborative working environment.

• What you need to do next
• If you have any questions, please contact us on Talent Acquisition@eisai. net
• Eisai Recruitment Statement

Diverse perspectives and experiences are critical to our success, and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role.

We look forward to receiving your application.

We believe that diverse and inclusive teams promote wellbeing, learning and innovation, helping Eisai serve our patients, their families, our employees, and society.

Our commitment is

• to embrace and celebrate our differences, respecting and valuing each other.
• to include equity, diversity, and inclusion practices in all that we do so everyone has a full sense of belonging.
• to value individual talent where every employee can be themselves and thrive in an environment of openness, trust, and integrity
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