At a Glance
- Tasks: Lead QA teams to ensure compliance and quality in healthcare products.
- Company: Join a leading pharmaceutical company making a difference in people's lives.
- Benefits: Competitive salary, relocation support, and opportunities for professional growth.
- Other info: Fully on-site role in Ireland with excellent career advancement opportunities.
- Why this job: Make a real impact in key therapeutic areas like immunology and oncology.
- Qualifications: MSc in Industrial Pharmaceutical Science and 10+ years in pharma leadership.
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.
Senior Manager Product QA in Manchester employer: Team Horizon
At Team Horizon, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. As a Senior Manager in Product QA, you will have the opportunity to lead impactful projects in the healthcare sector while benefiting from comprehensive professional development and growth opportunities. Our fully on-site position in Ireland not only offers a chance to work at the forefront of pharmaceutical advancements but also provides a supportive environment where your contributions directly enhance the lives of patients across key therapeutic areas.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Product QA in Manchester
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharma and healthcare sectors. Attend industry events or webinars, and don’t be shy about introducing yourself. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their compliance standards and recent news. We want you to show them you’re not just another candidate; you’re genuinely interested in making an impact in their team!
✨Tip Number 3
Practice your answers to common interview questions, especially those related to leadership and quality assurance. We suggest doing mock interviews with friends or mentors to build confidence and refine your responses.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Senior Manager Product QA in Manchester
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Product QA Manager role. Highlight your experience in compliance, GMP, and team leadership. 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 this role and how you can make an impact in the healthcare sector. We love seeing genuine enthusiasm!
Showcase Your Leadership Skills:Since this is a leadership position, be sure to highlight your experience managing teams and driving results. Share specific examples of how you've led projects or initiatives in the past. We want to know how you can lead our teams!
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. We can't wait to see what you bring to the table!
How to prepare for a job interview at Team Horizon
✨Know Your Stuff
Make sure you brush up on your knowledge of Good Manufacturing Practices (GMP) and the regulatory landscape, especially FDA and EMA guidelines. Being able to discuss these in detail will show that you're not just familiar with the basics but are ready to lead in this area.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in the past. Think about specific challenges you faced, how you motivated your team, and the outcomes. This role is all about managing people, so demonstrating your leadership style will be key.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to quality assurance and regulatory compliance. Practice articulating your thought process and decision-making skills in these scenarios, as they want to see how you handle real-world challenges.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to New Product Introductions and how they handle compliance issues. This shows your genuine interest in the role and helps you assess if the company aligns with your values and career goals.
