At a Glance
- Tasks: Lead Quality activities and ensure compliance with regulatory requirements for Millicent products.
- Company: Join a dynamic pharmaceutical company focused on quality and innovation.
- Benefits: Competitive salary, career growth opportunities, and a collaborative work environment.
- Other info: Flexible and adaptable team environment with opportunities for travel.
- Why this job: Make a real impact in the pharmaceutical industry while developing your leadership skills.
- Qualifications: Science degree and 5+ years in Quality within pharmaceuticals required.
The predicted salary is between 55000 - 65000 £ 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.
This job description should not be regarded as conclusive or definitive. It is a guideline within which the individual job holder works. It is not intended to be rigid or inflexible and may alter as the company's strategic direction changes.
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 TLNT1_NI in Larne 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 comprehensive support for professional growth, with opportunities to lead critical quality initiatives and engage in meaningful projects that impact patient safety. Our commitment to employee development, coupled with a dynamic team environment, makes Millicent a rewarding place to advance your career.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director TLNT1_NI in Larne
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in quality management. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA regulations and quality management systems. We want you to showcase your expertise and confidence when discussing your experience with product quality complaints.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can keep you fresh in the interviewer's mind and show your enthusiasm for the role. Plus, it’s a great chance to reiterate why you’re the perfect fit.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Millicent.
We think you need these skills to ace Associate Director TLNT1_NI in Larne
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Associate Director role. Highlight your experience in quality management and any relevant regulatory knowledge. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality in the pharmaceutical industry and how you can contribute to our team. Keep it engaging and relevant to the job description.
Showcase Your Leadership Skills:Since this role involves leading a team, make sure to highlight your leadership experience. Share examples of how you've successfully managed teams or projects in the past. We love seeing proactive and self-motivated candidates!
Apply Through Our Website:Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you're keen on joining our team at StudySmarter!
How to prepare for a job interview at Millicent Pharma Ni
✨Know Your Regulatory Stuff
Make sure you brush up on FDA regulations and any relevant compliance standards. Being able to discuss these confidently will show that you're not just familiar with the requirements but also understand their importance in the role.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams or projects in the past. Highlight your interpersonal skills and how you've managed conflicts or motivated team members, as this role requires strong leadership capabilities.
✨Be Ready for Technical Questions
Expect questions about Quality Management Systems and product quality complaint investigations. Review your past experiences and be ready to discuss specific cases where you made a significant impact on quality assurance.
✨Demonstrate Collaboration
This position involves working closely with various departments. Be prepared to talk about how you've collaborated with other teams in the past and how you can foster effective partnerships within the company.
