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- Tasks: Lead and support the implementation of electronic Quality Management Systems across global sites.
- Company: Join a leading pharmaceutical company focused on quality and compliance.
- Benefits: Competitive salary, professional development, and opportunities for global collaboration.
- Other info: Dynamic role with opportunities for growth and travel.
- Why this job: Make a real impact in the pharmaceutical industry while working with cutting-edge technology.
- Qualifications: Experience in eQMS, project management, and strong communication skills required.
The predicted salary is between 60000 - 80000 £ per year.
This will be a global position leading and supporting the implementation, migration, validation, and ongoing management of key electronic Quality Management Systems (eQMS) and pharmaceutical computerized systems across MedPharm sites in the UK and US, ensuring equal support and alignment across all sites. This includes acting as a Subject Matter Expert on MasterControl and other digital tools used to manage pharmaceutical quality data, ensuring compliance with GMPs, Annex 11, MHRA and applicable regulatory standards.
Essential Functions
- To effectively manage key Pharmaceutical Computerized System projects: delivering according to plan.
- To have a good working knowledge of electronic Quality Management Systems and its practical implementation at MedPharm.
- Lead and support the implementation of new tools in the electronic Quality Management System (e.g., Master Control) across the UK and US sites, ensuring smooth transition and compliance throughout all phases.
- Be the Subject Matter Expert (SME) for eQMS platforms including Master Control – provide training, troubleshooting, and ongoing support to staff at all MedPharm sites.
- Own and manage system lifecycle documentation – URS, risk assessments, IQ/OQ/PQ, data migration plans, and SOPs, ensuring consistency, compliance, and alignment across UK and US sites.
- To promote a culture of acceptance to change in support of ongoing programs of companywide improvement.
- Provide regular updates to Senior Management and key stakeholders including consolidated site-specific and global metrics, ensuring that risks, issues, and progress are reported across UK and US sites.
- Support all employees across MedPharm sites working on Computerized System projects such as computerized lab equipment and validation activities.
- Ensure adherence to GMPs, MHRA/FDA expectations and EMA requirements, Part 11, Annex 11 & 15, GLP, and latest industry guidance during project activities.
- Ensure that all employees have access to training on key processes and are appropriately trained.
- Drive post-implementation reviews and continuous improvement of computerized systems.
- To support the eQMS as a subject matter expert on Computer systems used to store and process pharmaceutical data.
- Maintain compliance and audit readiness for GxP electronic systems and support audits and inspections of all sites across the network.
- To act as the Records Archivist and manage the archiving process.
- Perform other duties as requested by management.
Key Relationships:
- Heads of Department (UK and US)
- Senior Management (UK and US)
- Quality Assurance (UK and US)
- External Customers (including during audits and inspections)
- Vendors
Travel requirements: 10% (possible 1 to 2 trips per year)
Education and Experience
- Bachelor’s in Life Sciences, Engineering, Computer Science, or related discipline are desirable but not essential.
- Training in Computer System Validation in a Pharmaceutical GMP environment and familiarity with GAMP 5 with minimum 5 years’ experience working in the pharmaceutical industry preferred.
- Familiar with Quality Management Systems is desirable (Deviations, Change Controls, CAPAs, etc.).
Knowledge, Skills, and Abilities
- Proven experience working with MasterControl, or similar eQMS platforms – configuration, administration, and user training.
- Strong working knowledge with CSV and GxP system implementations in a regulated pharmaceutical or life sciences environment.
- Hands-on experience with CSV activities relating to Empower CDS, including: Validation of new Empower installations and version upgrades, Data migration and system archiving, Management of audit trails, user access, and data integrity in Empower.
- Demonstrable success in leading system migrations or large-scale QMS digitalization projects.
- Experience in writing and maintaining validation documentation in line with GAMP 5.
- Good working knowledge of Computer System Validation.
- Familiar with electronic quality management systems (eQMS).
- Experience working within a Quality function on computer systems integration projects.
Personal Attributes
- Highly organized
- Effective communicator able to translate technical concepts to non-technical users.
- Strong project management and organizational skills.
- Able to influence and drive adoption of new systems across multidisciplinary teams.
QA Systems Manager – eQMS & CSV in Durham employer: MedPharm
Contact Detail:
MedPharm Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Systems Manager – eQMS & CSV in Durham
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work with eQMS or CSV. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Show off your expertise! When you get the chance to meet potential employers, whether at events or online, don’t hold back on sharing your knowledge about MasterControl and other eQMS tools. It’ll set you apart as a go-to person in the field.
✨Tip Number 3
Prepare for interviews by brushing up on compliance standards like GMPs and Annex 11. Be ready to discuss how you've tackled challenges in previous roles, especially around system migrations or validations. We want to hear your success stories!
✨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 and engaged with our company.
We think you need these skills to ace QA Systems Manager – eQMS & CSV in Durham
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QA Systems Manager role. Highlight your experience with eQMS and CSV, especially any work with MasterControl. We want to see how your skills align with what we're looking for!
Showcase Your Expertise: As a Subject Matter Expert, it's crucial to showcase your knowledge in electronic Quality Management Systems. Include specific examples of projects you've led or supported, and how you ensured compliance with GMPs and regulatory standards.
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read through your qualifications and experiences. We appreciate straightforward communication!
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 MedPharm
✨Know Your eQMS Inside Out
Make sure you brush up on your knowledge of electronic Quality Management Systems, especially MasterControl. Be ready to discuss how you've used these systems in the past and how they can be implemented effectively at MedPharm.
✨Showcase Your Compliance Knowledge
Familiarise yourself with GMPs, Annex 11, and other regulatory standards mentioned in the job description. Prepare examples of how you've ensured compliance in previous roles, as this will demonstrate your understanding of the industry's expectations.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and ability to manage change. Think of specific situations where you've led system migrations or handled challenges in a regulated environment, and be ready to share those stories.
✨Communicate Clearly and Confidently
As an effective communicator, you'll need to translate technical concepts to non-technical users. Practice explaining complex ideas simply, and be prepared to discuss how you've trained others in the past to ensure everyone is on the same page.