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- Tasks: Lead compliance activities and ensure quality management systems meet GxP standards.
- Company: Join a leading pharmaceutical company dedicated to quality and compliance.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth.
- Why this job: Be part of a team that shapes a strong compliance culture and drives continuous improvement.
- Qualifications: Strong QA experience in pharmaceuticals, especially in GMP/GDP and data integrity.
- Other info: Ideal for those passionate about quality assurance and regulatory affairs.
The predicted salary is between 43200 - 72000 £ per year.
This leadership role is central to ensuring the site's Quality Management System remains compliant with GxP standards. You’ll act as the site lead for QMS and data integrity, supporting ongoing compliance across validation, documentation, and quality processes. The role sits within the Quality leadership team and plays a key part in building a strong compliance culture across the UK site and affiliate operations.
Key Responsibilities:
- Lead QMS compliance activities across the site, focusing on continuous improvement and adherence to GxP
- Act as the site’s data integrity subject matter expert, advising and educating teams on best practice
- Maintain and develop the site’s validation master plan
- Provide quality oversight on investigations, CAPAs, change controls, and audit readiness
- Collaborate closely with QA, Manufacturing, Validation, and IT functions to ensure systems and processes meet regulatory expectations
- Contribute to the Quality leadership team and support cross-functional quality initiatives
Ideal Experience:
- Strong experience in pharmaceutical QA, with a focus on GMP/GDP
- Background in validation and quality systems (e.g. change control, CAPA, audit prep)
- Proven expertise in data integrity and compliance within a regulated environment
- Confident communicator with solid stakeholder engagement skills
- Familiarity with electronic quality systems (e.g. TrackWise, LIMS) is beneficial
Regulatory Affairs & Quality Assurance Manager employer: Nexia Life Sciences
Contact Detail:
Nexia Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs & Quality Assurance Manager
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those working in regulatory affairs and quality assurance. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and best practices.
✨Tip Number 2
Familiarise yourself with GxP standards and the specific regulations that apply to the role. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality management.
✨Tip Number 3
Prepare to discuss your experience with quality management systems and data integrity during interviews. Be ready to provide examples of how you've successfully led compliance activities or improved processes in previous roles.
✨Tip Number 4
Showcase your communication and stakeholder engagement skills by preparing scenarios where you've effectively collaborated with cross-functional teams. Highlighting these experiences can set you apart as a strong candidate for this leadership position.
We think you need these skills to ace Regulatory Affairs & Quality Assurance Manager
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Regulatory Affairs & Quality Assurance Manager position. Make sure you understand the key responsibilities and ideal experience required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your strong experience in pharmaceutical QA, particularly focusing on GMP/GDP. Provide specific examples of your background in validation and quality systems to demonstrate your suitability for the role.
Showcase Communication Skills: Since the role requires confident communication and stakeholder engagement, include examples in your application that showcase your ability to effectively communicate with various teams and stakeholders.
Tailor Your Application: Customise your CV and cover letter to reflect the specific requirements of the job. Mention your familiarity with electronic quality systems like TrackWise or LIMS, as this could set you apart from other candidates.
How to prepare for a job interview at Nexia Life Sciences
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of GxP standards and how they apply to Quality Management Systems. Be prepared to discuss specific examples from your past experience where you ensured compliance and improved processes.
✨Demonstrate Leadership Skills
As this role is a leadership position, it's crucial to convey your ability to lead teams and foster a compliance culture. Share instances where you've successfully led QMS initiatives or guided teams through audits and investigations.
✨Prepare for Technical Questions
Expect questions related to validation master plans, CAPA processes, and data integrity best practices. Brush up on these topics and be ready to explain your approach to maintaining compliance in a regulated environment.
✨Engage with Stakeholders
Since stakeholder engagement is key, prepare to discuss how you've collaborated with various functions like QA, Manufacturing, and IT. Highlight your communication skills and provide examples of how you've effectively managed cross-functional projects.
