At a Glance
- Tasks: Lead transformative QMS projects in a dynamic healthcare tech environment.
- Company: Join a forward-thinking healthcare solutions provider focused on innovation.
- Benefits: Enjoy global growth opportunities, competitive salary, and a supportive culture.
- Other info: Be part of a diverse team that values inclusion and personal growth.
- Why this job: Make a real impact at the intersection of healthcare and technology.
- Qualifications: 10-15 years in project management with strong QMS transformation experience.
The predicted salary is between 70000 - 85000 £ per year.
We are a technology-led healthcare solutions provider, driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. At Indegene, you gain a unique career experience that celebrates entrepreneurship, guided by passion, innovation, collaboration and empathy.
We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. Our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.
We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose.
If this excites you, then apply below.
Roles and Responsibilities:- Program & Project Leadership
- Lead large-scale QMS transformation programs across multiple regions and business units
- Define project scope, objectives, timelines, and deliverables aligned with organizational goals
- Manage project plans, risks, issues, dependencies, and budgets
- Ensure successful delivery within scope, time, and cost constraints
- Stakeholder Management
- Act as the primary point of contact for senior leadership and client stakeholders (West Pharma)
- Facilitate governance meetings, steering committees, and status reporting
- Build strong relationships across Quality, IT, and business teams
- QMS Transformation & Compliance
- Drive implementation or enhancement of QMS platforms (e.g., TrackWise, Veeva Vault QMS, etc.)
- Ensure compliance with global regulatory standards such as FDA (21 CFR Part 11), GxP, ISO standards (e.g., ISO 13485)
- Support process harmonization, standardization, and digital transformation initiatives
- Change Management
- Lead organizational change management activities
- Drive user adoption, training, and communication strategies
- Manage resistance and ensure smooth transition to new systems/processes
- Cross-functional Collaboration
- Work closely with IT teams for system implementation and integration
- Collaborate with Quality and Regulatory teams for validation and compliance
- Coordinate with vendors and third-party partners
- Risk & Quality Management
- Identify, assess, and mitigate project risks
- Ensure quality of deliverables and adherence to project governance standards
- Oversee validation documentation (IQ/OQ/PQ) where applicable
- PMP / PRINCE2 certification
- Experience working with global stakeholders and distributed teams
- Strong leadership, communication, and stakeholder management skills
- Knowledge of Agile and/or hybrid project methodologies
- Exposure to digital transformation and data-driven quality systems
- Strategic thinking and execution
- Strong problem-solving and decision-making
- Excellent communication and influencing skills
- Ability to manage ambiguity and complex environments
- Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred)
- 10–15+ years of project/program management experience
- Strong experience in QMS transformation within Pharma/Medical Devices
- Proven track record of delivering large-scale transformation programs
- Deep understanding of regulatory frameworks (FDA, GxP, ISO)
- Experience with QMS tools (TrackWise, Veeva Vault, etc.)
- Overall experience: 10-15 years
- Minimum 5-year experience with Medical Devices Regulatory Affairs
- Minimum 3-year experience leading projects/teams; 5-year or more experience in respective area of expertise
- RAC (Regulatory Affairs Certification) Certified is a plus
- PMP certification is a plus
- Industry experience and knowledge of Medical device/IVD/SaMD/ Drug-device combination products related regulatory affairs
- Experience in relevant regulatory subjects in medical device manufacturing organizations, professional services organizations, healthcare delivery organizations, or in consultancies serving those organizations
- Experience interfacing effectively with domestic and international regulatory agencies
- In-depth knowledge of medical device regulations- US FDA, EU MDD, EU MDR & other country specific laws & regulations like TGA, NMPA, Indian regulations etc
- Ability to manage small to big sized projects: organized, independent, and results-oriented
- Superb analytical and excellent communication skills, strong team ethics, and attention to detail
- Good presentation skills
- Strong influencing and communication skills and the ability to comprehend complex regulatory topics and disseminate information to a varied audience.
EQUAL OPPORTUNITY
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
Quality Management System Manager in City of London employer: Indegene
Indegene is an exceptional employer that thrives at the intersection of healthcare and technology, offering a dynamic work culture that fosters innovation, collaboration, and personal growth. With a commitment to nurturing future leaders, employees benefit from accelerated career opportunities, mentorship, and the chance to lead transformative projects on a global scale. Join us in a vibrant environment where your contributions are valued, and you can make a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Management System Manager in City of London
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like Indegene.
✨Tap into Professional Associations
Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at Indegene.
✨Apply Through Our Website for Better Visibility
When you find roles that excite you, especially at places like Indegene, don’t forget to apply through our website. This can sometimes give you an edge by showing the employer you’re savvy and committed to finding the right fit.
We think you need these skills to ace Quality Management System Manager in City of London
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at Indegene.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at Indegene.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to Indegene. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at Indegene. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at Indegene
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research Indegene’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
