Eisai EMEA
Quality Operations Manager
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The Company
Eisai is a leading research-based pharmaceutical organization 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 organization with a human healthcare philosophy, which means that we put the patient first in everything we do.
Your new role
Responsible for Quality Operations and Quality Assurance activities, ensuring GMP compliance and quality system support for the manufacture, packaging, testing, storage, and distribution of marketed drug products at EML and third-party manufacturers.
- Support timely batch review, release, and distribution activities, ensuring compliance with current GMP requirements and Eisai quality standards.
- Maintain and improve the EML Quality Management System (QMS), including electronic TrackWise, in accordance with EU GMP/GDP, WHO, FDA 21 CFR Parts 210, 211, and Part 11 requirements.
- Drive continuous improvement initiatives across quality systems and operational processes, collaborating with internal and third-party stakeholders to enhance compliance and efficiency.
- Represent Quality Operations on cross-functional projects, providing quality leadership and ensuring activities are executed in a controlled, compliant manner aligned with GMP and Eisai corporate expectations.
Location: On-site role.
Duties are performed to ensure:
- A safe working environment is maintained for self and other Eisai employees, ensuring all near-miss incidents and accidents are reported in accordance with procedures.
- The Quality of products manufactured and released is assured through adherence to all procedures.
- Opportunities to improve operations and reduce cost are identified and progressed through the continuous improvement and demand innovation initiatives.
- Eisai’s philosophy of hhc is at the forefront of daily activities.
- All stakeholder and customer expectations are understood and met through communication.
- Performance is in line with personal and Eisai objectives with demonstrated behaviors and competencies.
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What are we looking for?
- Demonstrated experience in a Quality Management or Quality Assurance leadership role within the pharmaceutical industry.
- Extensive knowledge of Quality Assurance, Quality Systems, GMP, GDP, and pharmaceutical manufacturing and packaging processes.
- Strong understanding of global GMP regulations and guidelines, with the ability to interpret, implement, and maintain compliance requirements.
- Proven ability to build effective relationships and collaborate across functions, sites, affiliates, and external partners.
- Strong communication and influencing skills, with the ability to engage stakeholders at local, regional, and global levels.
- Demonstrated ability to analyze complex data, identify trends, and present clear, actionable insights.
- Proficient in Microsoft Office applications, including Word, Excel, and PowerPoint.
- Effective leadership skills with the ability to drive results, influence decision-making, and motivate cross-functional teams without direct reporting authority.
What we offer in return
Eisai offers a competitive salary and excellent wider benefits package that includes:
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- Electric charging points for Electric/Hybrid vehicles
- Discretionary Bonus
- Free onsite parking
- Subsidised onsite restaurant and coffee shop
- Learning and development opportunities
- Retail discounts
- 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 are interested in this position, please click ‘apply now’ at the top of this advert. Upon submitting your application, you will be asked to complete your profile and upload a copy of your CV along with any additional information to support your application.
If you have any questions, please contact us on TalentAcquisition@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.
Eisai EMEA EDI Commitment Statement
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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