At a Glance
- Tasks: Lead Quality activities and ensure compliance with regulatory requirements in a dynamic environment.
- Company: Join a leading pharmaceutical company committed to quality and innovation.
- Benefits: Competitive salary, career growth opportunities, and a collaborative team culture.
- Other info: Flexible work environment with opportunities for travel and professional development.
- Why this job: Make a real impact on product quality and work with a passionate team.
- Qualifications: 5+ years in Quality within pharma, strong leadership, and communication skills.
The predicted salary is between 60000 - 80000 £ per year.
Lead Quality activities to ensure Millicent operates in compliance with regulatory requirements and provide Quality support for the Larne site and Millicent commercial products.
Key Duties and Responsibilities:
- Management and Quality oversight of the product quality complaints system for Millicent products.
- Review and trend complaint data and present findings for Quality Management Review.
- Provide Quality oversight of Third-Party Provider complaint intake centre.
- Develop and maintain the Millicent Quality Management System to ensure appropriate systems and procedures are in place for the management and control of regulated activities.
- Participate in the self-inspection programme and ensure systems and procedures used at Millicent comply with regulatory requirements.
- Prepare for and follow up on external audits and regulatory inspections.
- Stay current with emerging regulatory guidance within the industry.
- Work collaboratively as an integral part of the Larne QA Team.
- Ensure effective partnership with other areas of the company including Operations, Quality, Regulatory, Clinical and Pharmacovigilance.
- Represent Quality in internal and external meetings and teleconferences in a positive, collaborative manner.
- Demonstrate high levels of leadership and people management skills.
- Contribute to the review of company policies and procedures.
- Undertake any other duties assigned by Senior Management.
Human Resource Management:
- Adhere to the Company's policies and procedures.
- Provide guidance and support to team members.
Person Specification:
Essential Skills:
- Education: Science degree.
- Experience: Minimum 5 years' experience working within the Quality department of a pharmaceutical company. Experience at a managerial level.
- Specialist Knowledge: Experience of product quality complaint investigation. Knowledge of FDA regulations. Experience of Quality Management System maintenance. Knowledge of dosage forms and drug delivery.
- Special Skills and Dispositions: Excellent interpersonal and leadership skills. Ability to be flexible and adaptable to change. Proactive and self-motivated, with a high level of initiative and persistence. Demonstrable ability to set and meet targets. Experience working within a multidisciplinary team. Demonstrable ability to communicate fluently in English, both orally and in writing.
Location:
- Available to attend the place of work in Larne, UK.
- Amenable to work-related travel as required.
Desirable Skills:
- Science degree (preferably Pharmacy).
- Experience in small to medium-sized pharmaceutical companies.
- Experience in the investigation and trending of product quality complaints.
- Experience of working in an FDA-regulated environment.
Associate Director employer: Millicent Pharma Ni
Millicent is an exceptional employer that prioritises compliance and quality in the pharmaceutical industry, offering a collaborative work culture at our Larne site. Employees benefit from robust professional development opportunities, a supportive team environment, and the chance to lead impactful quality initiatives that ensure the safety and efficacy of our products. Join us to be part of a forward-thinking organisation that values innovation and employee growth.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Millicent Pharma Ni. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Millicent Pharma Ni.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Millicent Pharma Ni. 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 Millicent Pharma Ni is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Associate Director
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 Millicent Pharma Ni!
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 Millicent Pharma Ni 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 Millicent Pharma Ni!
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 Millicent Pharma Ni, 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 Millicent Pharma Ni
✨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 Millicent Pharma Ni 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 Millicent Pharma Ni’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.
