Quality Control Technical Project Manager - Permanent Position

Consortium; Hatfield; Hybrid; GBP 70,000 - 100,000; Full time

Benefits offered by this job

Electric charging points for Electric/

Discretionary Bonus

Free onsite parkingSubsidised onsite

Learning and development opportunities

Well-being & mental health awareness

Multi-faith prayer room

Job summary

Eisai's Knowledge Centre in Hatfield seeks a Quality Control Technical Project Manager to lead QC laboratory technical projects, manage a team of specialists, and ensure electronic systems like LIMS/ CDS comply with GMP. You will drive equipment maintenance, method transfer, product introductions, and pharmacopeia reviews, while aligning with Eisai's standards and five-year replacement planning.

This permanent role offers a competitive salary and benefits, and places you at Eisai's EKC in the

Qualifications

• Degree in science or equivalent experience.
• Strong knowledge of QC equipment and electronic systems qualification/validation.
• Minimum two years in technical management of QC equipment and systems.
• Experience as a laboratory administrator or end user of QC electronic systems.
• Excellent communication and people management skills.
• Ability to analyze user requirements and drive improvements.

Responsibilities

• Manage a team of technical specialists in QC lab.
• Oversee QC equipment and electronic systems in manufacturing, packaging and testing.
• Lead global change, method transfer and pharmacopeia reviews.
• Develop and maintain a five-year equipment replacement plan.
• Ensure compliance with GMP and data integrity standards.
• Lead education and training of QC staff on equipment and software.
• Review and approve SOPs and quality policies.
• Drive change management to keep data available and accurate.

Skills

QC equipment knowledge

Electronic systems qualification

People management

GMP knowledge

Communication skills

Data interpretation

Education

Science degree

Tools

Word

Excel

PowerPoint

Job description

Quality Control Technical Project Manager - Permanent Position

Quality Control Technical Project Manager - Permanent Position

Location: Mosquito Way, Hatfield AL10 9SN, UK

Highlighted points for this job

Technical management role within QC laboratory

Eisai offers competitive salary and comprehensive benefits

Responsibilities include team management and QC compliance

Qualifications include science degree and GMP knowledge

Job based at EMEA Knowledge Centre

The Company

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

This job 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 PowerPoint
• 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 parkingSubsidised 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.

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