At a Glance
- Tasks: Lead QA teams, ensure compliance, and manage product quality in healthcare.
- Company: Join a leading pharmaceutical company making a difference in people's lives.
- Benefits: Competitive salary, career growth, and the chance to impact key therapeutic areas.
- Other info: Dynamic environment with opportunities for innovation and professional development.
- Why this job: Make a real difference in healthcare while advancing your career in a leadership role.
- Qualifications: MSc in Industrial Pharmaceutical Science and 10+ years in healthcare/pharma.
Team Horizon is seeking a Senior Product QA Manager & QP to join our client’s team.
This is a leadership role and is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs).
Why you should apply
- This is an excellent opportunity to make an impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience.
What you will be doing
- Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management.
- Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems.
- Lead batch review and release, documentation, checks, and test completion.
- Oversee validation of manufacturing and testing processes and accurate record keeping.
- Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications.
- Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches
- Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA).
- Chair Change Review Boards, approve changes, oversee completion of QA tasks.
- Conduct internal/external audits and participate in regulatory/customer inspections.
- Manage complaint investigations, coordinate product recalls, and address quality defects.
- Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and QA Policies.
- Review and approve Product Quality Reviews (PQRs) and track finished product data.
- Provide QP oversight for SAP, LIMS setup changes, and manage site quality metrics.
- Act as Designee for the Quality Director when required.
- Lead department/site goals, provide technical leadership/guidance on QP/regulatory matters, and present technical data for decision-making.
What you need to apply
- MSc in Industrial Pharmaceutical Science (or a comparable course recognized for QP status per Article 49 of Directive 2001/83/EC).
- Minimum 10 years' experience in the healthcare/pharma sector within FDA/EMA approved environments.
- Demonstrated experience leading teams, with 7+ years in leadership roles Demonstrated attention to detail, strong problem-solving and innovative thinking abilities.
- Results-driven mindset with proven prioritization skills and commitment to quality.
- High integrity, strong work ethic, excellent verbal/written communication, and interpersonal skills
QP & Senior QA Manager in Sligo employer: Team Horizon
At Team Horizon, we pride ourselves on being an exceptional employer that values innovation and integrity in the healthcare sector. Our collaborative work culture fosters professional growth, offering ample opportunities for leadership development and impactful contributions to life-changing therapies. Located in a dynamic environment, we provide our employees with the resources and support needed to excel in their roles while making a meaningful difference in patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land QP & Senior QA Manager in Sligo
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Team Horizon. 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 Team Horizon.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Team Horizon. 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 Team Horizon is looking for. A tailored application can really make you stand out!
We think you need these skills to ace QP & Senior QA Manager in Sligo
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 Team Horizon!
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 Team Horizon 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 Team Horizon!
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 Team Horizon, 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 Team Horizon
✨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 Team Horizon 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 Team Horizon’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.
