At a Glance
- Tasks: Lead and manage quality functions in Pharma, ensuring compliance and patient safety.
- Company: Join Orbia, a forward-thinking company committed to innovation and quality.
- Benefits: Competitive salary, career development, and a diverse, inclusive workplace.
- Other info: Be part of a dynamic team focused on excellence and collaboration.
- Why this job: Make a real impact in the Pharma industry while driving continuous improvement.
- Qualifications: 10+ years in quality management, with strong leadership and communication skills.
The predicted salary is between 60000 - 80000 £ per year.
Occasional travel to customer sites within the UK/Globally expected.
Main Purpose
Overall leadership and management of the Quality functions (Pharma/cGMP/Medical & Industrial) for Orbia's Fluor & Energy Materials Operations and Pharma business unit. Working closely with the Operations Director and Pharma business leader, translate business strategy & goals into strategic and operational plans for the UK Quality functions across multiple operating locations (& regions), provide visible leadership to the UK Quality teams and collaborate effectively with internal and external customers/stakeholders to ensure delivery of business objectives.
Main Responsibilities
- Overall accountability for all aspects of UK Quality across Orbia F&EM's Operations and Pharma Business Unit.
- Direct leadership and management of the Quality teams across Orbia F&EM's UK locations and indirect management of all quality aspects across other operating locations with the overall aim of ensuring patient safety, regulatory compliance, world-class service to Orbia's customers, efficient operations and long-term value-creation for Orbia.
- Working through the Quality management teams, identify, define and implement the requirements of quality policies, standards, processes and procedures to achieve and maintain world class performance.
- Monitor and assess potential future quality and regulatory issues to determine the impact and formulate the most effective strategy for the business.
- Through leading by example, ensure that the quality functions across all sites are seen as collaborative partners in serving Orbia's Medical/Pharma customers.
- Promote a culture of quality-beyond-compliance, drive continuous improvement/lean ways of working, value mindset and active listening and support other stakeholders.
- Develop and maintain functional knowledge and expertise in the medical quality functional areas.
- Recruit, train, develop the Quality teams and promote/nurture cross-site or cross-discipline support, communication and collaboration to maximise value and minimise risk for the business.
- Keep abreast of Orbia's strategic plans by maintaining proactive engagement with business and leadership teams to provide necessary insights and support.
- Establish and maintain necessary expertise, networks, contacts and processes to monitor and assess any relevant regulatory requirements, risks or opportunities.
- Establish and maintain necessary expertise, resources, systems and tools so that Orbia can leverage the right technological solutions as a world class pharma business.
- Manage the medical quality operational and capital expenditure in line with budgets and business plans.
- Act as one of the Rocksavage Management team, providing input to strategy, leadership and accountability for our UK objectives.
Knowledge/Experience Required
- Strong technical background with 10+ years' experience in quality or a related function within a pharmaceutical or excipient manufacturing (cGMP) environment.
- 5+ years leadership experience; strong people management capability is essential and a key differentiator for this role.
- Experience of being part of multi-disciplined leadership or management teams in a manufacturing environment is desirable.
- Proven experience with management systems including implementation and auditing (ISO 9001/14001/18001 or 45001) will be a distinct advantage.
- Proven experience within Pharma Quality management systems working to UK/EU GMP guidelines (EudraLex Volume 4, Annex 13 and/or IMP 2017/1569) will be a distinct advantage.
- Experience of change management, lean/continuous improvement processes, mentoring and developing others will be advantageous.
- Technical competence in a broad range of topics e.g. cGxP, regulatory, analytical, laboratory practices, auditing, quality assurance, IT related to quality, change management, deviations, NCs, etc.
- Excellent communication skills, verbal, written and electronic.
- Influencing and rational persuasion skills.
- High safety standards, results-orientated, concern for impact and analytical skills.
- Knowledge of best practices and latest innovations in IT and data management/integrity will be a distinct advantage.
Behaviours that can help you succeed at Orbia
- Develop yourself & Others
- Drive Results
- Provide Vision & Direction
We welcome purpose-driven dreamers, doers, and builders, recognizing that it takes difference to make a difference. If you're ready to bring your skills, talents, and perspective to moving your career, the company, people, and the planet forward, we'd like to hear from you.
We believe that every voice matters; every community deserves respect; and every challenge is an opportunity and united by empathy, we are stronger for our different perspectives. We are dedicated to building a more diverse, inclusive, and equitable workplace that supports the needs of all our employees regardless of their role, location, identity, and background.
Senior Quality Manager in Thornton-Cleveleys employer: Orbia group
At Orbia, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation within the pharmaceutical sector. Our commitment to employee growth is evident through comprehensive training programs and leadership opportunities, ensuring that our team members thrive in their careers while contributing to meaningful projects that prioritise patient safety and regulatory compliance. Located in the UK, our diverse and inclusive environment empowers every voice, making it a rewarding place to work for those passionate about making a difference.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Quality Manager in Thornton-Cleveleys
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We think you need these skills to ace Senior Quality Manager in Thornton-Cleveleys
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 Orbia group!
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 Orbia group 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 Orbia group!
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 Orbia group, 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 Orbia group
✨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 Orbia group 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
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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.
