Sciensus
Validation and Compliance Manager
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Why this role?
We're looking for a Validation & Compliance Manager to join our Quality team and play a key role in ensuring the integrity, compliance and effectiveness of our validation and temperature management programmes across the UK and Rare businesses.
This is a highly visible role that combines technical expertise, quality leadership and cross-functional collaboration. You'll act as the subject matter expert for validation, temperature monitoring and GDP compliance, ensuring our operations continue to meet regulatory requirements while driving continuous improvement across the business.
If you're passionate about quality, enjoy solving complex compliance challenges and want to make a direct impact on patient care, we'd love to hear from you.
What You'll Be Doing
- Managing, developing and maintaining the Validation Master Plan.
- Leading the design and execution of validation protocols, including temperature mapping of product storage areas, fleet vehicles and temperature-controlled packaging solutions.
- Overseeing temperature monitoring systems across our estate and fleet, including calibration activities, remedial works and ongoing compliance monitoring.
- Acting as the Subject Matter Expert (SME) for validation, temperature monitoring and calibration activities.
- Partnering with operational and business teams to develop and implement SOPs, policies and quality processes.
- Supporting and facilitating risk assessments, including FMEA activities.
- Supporting Change Control processes and associated risk assessments.
- Conducting internal audits in line with the company audit schedule.
- Supporting regulatory inspections and customer audits, including preparation and participation activities.
- Driving compliance with Good Distribution Practice (GDP) requirements and quality management system processes.
- Providing coaching, guidance and quality expertise to operational teams to promote a culture of compliance and continuous improvement.
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Who We're Looking For
You'll be an experienced quality or compliance professional with a strong understanding of validation principles and regulatory requirements within a healthcare, pharmaceutical, pharmacy or manufacturing environment.
- Experience working within GDP-regulated environments.
- Previous experience managing or supporting validation programmes.
- Experience supporting Quality Management Systems and regulatory compliance activities.
- Internal auditing experience.
- Strong analytical and problem-solving skills.
- The confidence to influence, coach and engage stakeholders at all levels.
- Strong communication and relationship-building skills.
- Experience supporting regulatory inspections would be advantageous.
What's in it for you?
- An opportunity to make a significant impact on quality, compliance and patient safety.
- Exposure to a broad range of validation and regulatory activities across the business.
- The chance to work with experienced quality and operational teams.
- Ongoing professional development and career growth opportunities.
- A collaborative environment where your expertise and ideas will be valued.
What do we offer?
We work hard to make sure colleagues feel motivated, developed, and recognised for the great work they do.
- Offer a salary from £35,000 per annum and our comprehensive benefits package, including:
- 25 days annual leave plus bank holidays
- Contribution based pension scheme
- Employee benefits platform
- Life insurance
- Access to various well-being platforms
- Private medical insurance (after qualifying period)
- Refer a friend scheme
- Ongoing learning and development opportunities
- Annual company event
- Bike to work scheme
- Yearly pay reviews
Who we are?
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Sciensus is a leading European life sciences organisation with over 30 years of experience, helping over 240,000 patients a year gain access to beneficial treatments and life-changing medicines. We empower patients with digital tools like the Sciensus Intouch app, to take control of their treatments, report on symptoms and quality of life, and access support through their care journey. We blend this with personalised support services from our team of over 700 licensed clinical staff. Whether we’re delivering cancer treatment in someone’s home or showing patients how to self-administer medicines, the human-touch care we provide helps patients make the most of their treatment.
Our Values
We are a Disability Confident Committed Employer who has successfully gained the National Equality Standard (NES is the UK’s leading Equity, Diversity and Inclusion standard which was developed by the UK Government and the CBI). We are committed to the fair treatment of all candidates, regardless of race, gender, religion, sexual orientation, age or disability. We welcome applications from all and we select candidates based on skills, qualifications, and experience. Please talk to us during the application process to discuss any reasonable adjustments you may require.
We are committed to achieving Net Zero and reducing our ecological footprint and constantly working on new initiatives, some of our more recent ones include working towards Level 2 in the Greener Pharmacy Toolkit and replacing many of our vans with lower CO2 emission models. For information on other projects and our wider approach to sustainability please visit our corporate website.
The Process
One of the talent team will reach out for an initial screening call before face-to-face interviews are arranged.
Start dates are given after full pre-employment checks are completed.
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