At a Glance
- Tasks: Lead Quality Operations and ensure compliance in pharmaceutical manufacturing and distribution.
- Company: Eisai, a leading research-based pharmaceutical organisation focused on human healthcare.
- Benefits: Competitive salary, electric vehicle charging, onsite perks, and learning opportunities.
- Other info: Join a diverse team that values inclusion and personal growth.
- Why this job: Make a real impact on patient care while driving quality and compliance in a dynamic environment.
- Qualifications: Experience in Quality Management within the pharmaceutical industry and strong communication skills.
The predicted salary is between 56700 - 69300 £ per year.
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
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 Track Wise, 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.
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 behaviours and competencies.
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 analyse complex data, identify trends, and present clear, actionable insights.
- Proficient in Microsoft Office applications, including Word, Excel, and Power Point.
- 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,
- Electric charging points for Electric/Hybrid vehicles
- Discretionary Bonus
- Free onsite parking
- Subsidised onsite restaurant and coffee shop
- Learning and development opportunities
- 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
- #J-18808-Ljbffr
Quality Operations Manager in Hatfield employer: Eisai EMEA
Eisai is an exceptional employer that prioritises a human healthcare philosophy, ensuring that patient needs are at the forefront of our operations. Located in Hatfield, we offer a dynamic hybrid working environment, competitive salaries, and a comprehensive benefits package, including learning and development opportunities to foster employee growth. Our commitment to building high-performing teams and supporting digital transformation makes Eisai a rewarding place to advance your career in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Operations Manager in Hatfield
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Eisai EMEA. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Eisai EMEA.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Eisai EMEA. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Eisai EMEA is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Quality Operations Manager in Hatfield
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Eisai EMEA!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Eisai EMEA that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Eisai EMEA!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Eisai EMEA, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Eisai EMEA
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Eisai EMEA that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Eisai EMEA’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
