Full-Time
Quality Release Specialist
Clinigen
501-1,000 employees
Global pharmaceutical services and medicine access
No salary listed
Byfleet, UK
In Person
Bachelor's
 Biology & Biotech (1) |
|---|
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- A degree in Life Sciences, Pharmacy or Chemistry, or an equivalent qualification.
- Experience in a Quality Assurance or related role.
- Knowledge of Good Manufacturing Practice and Good Distribution Practice guidelines for human medicinal products.
- Understanding of WDA(H), MS and MIA(IMP) licence requirements.
- Strong organisational, planning and administrative skills.
- Excellent information technology skills, particularly Microsoft Office.
- Ability to communicate confidently and engage at all levels.
- Ability to focus on solutions, adapt and manage changing priorities.
- High levels of accountability, accuracy and attention to detail.
- Manage day-to-day activities within the Quality Management System, partnering with cross-functional teams to investigate, review and close quality records within the electronic Quality Management System.
- Create, review and approve quality documentation, including standard operating procedures, work instructions and forms, ensuring compliance with Good Documentation Practice.
- Maintain Good Manufacturing Practice and Good Distribution Practice standards, managing accurate paper and electronic quality records in line with company procedures and regulatory requirements.
- Investigate quality issues and customer complaints, working collaboratively to identify root causes, prioritise actions and implement pragmatic, compliant solutions.
- Communicate quality system requirements to employees, support quality-related training, and influence others to achieve quality objectives.
- Support internal, external and regulatory audits and inspections, including preparation, participation and completion of corrective and preventative actions.
- Drive continual improvement by analysing quality data, identifying process improvement opportunities, acting as a Quality stakeholder on projects, managing key supplier relationships, escalating risks to management, and supporting the wider Quality team as needed.
Clinigen provides pharmaceutical services and medicines to help patients access treatments. It revitalizes niche, hospital-only medicines and offers end-to-end services across the product lifecycle through three divisions: Clinical Services, Access and Commercialisation, and Lifecycle Services. The company supports pharma partners with clinical trial supply, managed access programs for unlicensed medicines, market access, and regulatory affairs, distributing products in 100+ countries. Its goal is to ensure ethical patient access by combining product revival with comprehensive lifecycle management on a global scale.
Company Size
501-1,000
Company Stage
IPO
Headquarters
Branston, United Kingdom
Founded
2010
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Simplify's Take
What believers are saying
- Greg Skalicky became CEO on 20 July 2026, bringing Eversana commercialization experience.
- Clinigen finalized SSI Strategy on 21 November 2025, expanding U.S. and European advisory reach.
- Japan listed PreemieFort on 18 March 2026, supporting near-term revenue from neonatal access.
What critics are saying
- Acting CEO turnover from September 2025 to July 2026 signals board instability.
- SSI Strategy integration threatens synergy delivery and consultant retention through 2026.
- EVERSANA, Syneos, and in-house pharma teams can disintermediate Clinigen's services entirely.
What makes Clinigen unique
- Clinigen spans clinical supply, compassionate use, and commercialization across one lifecycle platform.
- Its Japan approvals expertise turned PreemieFort into the first human-milk prescription drug there.
- SSI Strategy adds 145 consultants and 280 biopharma relationships for lifecycle consulting.
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Benefits
Paid Vacation
Performance Bonus
Professional Development Budget
Training Programs
Growth & Insights and Company News
6 month growth
↓ -4%1 year growth
↓ -5%2 year growth
↓ -4%News & articles. At ConnectWeb Connectweb has a team of editors and researchers collating the most relevant information to you and your industry. All Directories' publications and sites provide a wealth of information for research or marketing, and are used by public and corporate libraries, educational institutions, government departments, corporations and SMEs across the country. You are here: Home News Access the latest company news and announcements distributed through Medianet. Technology & Innovation 20/07/2026 21:18 Clinigen appoints Greg Skalicky as Chief Executive Officer. LONDON-BUSINESS WIRE- Clinigen, the global pharmaceutical services company dedicated to accelerating access to critical medicines worldwide, today announced the appointment of Greg Skalicky as Group Chief Executive Officer, effective 20 July 2026. Greg succeeds Dr Varun Sethi, who has served as Acting CEO since September 2025. Skalicky brings more than 30 years of leadership experience, with a unique blend of clinical and commercial expertise in the pharmaceutical, biotechnology and healthcare sectors. He joins Clinigen following a distinguished career leading large-scale organisations, with a track record of driving growth, global expansion, and transformative partnership structures. Most recently he served as President of Eversana, where he designed and implemented the industry's first fully integrated commercialisation model. Prior to Eversana, he held senior leadership roles at Syneos Health (formerly inVentiv Health) and PharmaNet, managing major global client relationships with leading pharmaceutical companies. As Group CEO, Skalicky will lead Clinigen through its next phase of growth, building on the company's strong position as a trusted partner to pharmaceutical and biotechnology companies across clinical trial services, strategic staffing and global compassionate use programs. "Greg is an accomplished healthcare executive with deep industry expertise and a proven ability to scale global organisations," said Paul Carter, Chairman of Clinigen. "His extensive experience across commercialisation, patient access, and pharmaceutical services makes him exceptionally well positioned to lead Clinigen into its next chapter. Our ambition is to offer pharma and biotech clients a fully integrated partner to deliver access to critical medicines across the pharmaceutical lifecycle, and Greg's experience positions him perfectly to deliver on that vision. I would like to thank Varun for his outstanding leadership as Acting CEO, during which time he has continued to strengthen the business and advance our strategic priorities." "I am honoured to join Clinigen at such an exciting time in the company's evolution," said Greg Skalicky. "Clinigen has built an outstanding reputation for solving some of the most complex access and supply challenges in healthcare. The company's mission, expertise, and commitment to patients deeply resonate with me. I look forward to working alongside our talented global team to accelerate growth, enhance client value, and expand access to critical medicines for patients around the world." Clinigen serves more than 1,000 pharmaceutical and biotechnology partners globally and operates across five continents. Under Skalicky's leadership, the company will continue to focus on operational excellence, customer partnership, innovation, and strategic expansion. About Clinigen Clinigen is a global pharmaceutical services company trusted by pharmaceutical and biotechnology organisations worldwide. With decades of experience, Clinigen helps accelerate access to critical medicines across the product lifecycle. Headquartered in the UK with operations across Europe, the Americas, and Asia-Pacific, Clinigen's purpose is to be the global pathfinder accelerating patient access to critical medicines. Clinigen was acquired by Triton Partners in April 2022. Contact details: For further information, please contact: Julian Tyndale-Biscoe (UK)- [email protected] Carrie Young (US)- [email protected] Aanchal Agarwal (APAC)- [email protected] * images - clinigenlogo.jpg download. ConnectWeb. ConnectWeb is Australia's leading publisher of biographical data, directories and specialist newsletters. With ConnectWeb you gain access to its comprehensive database of contacts and companies in media, government and associations. Connect with Connectweb.
Clinigen, a global pharmaceutical services company, has appointed Greg Skalicky as group chief executive officer, effective 20 July 2026. He succeeds Dr Varun Sethi, who served as acting CEO since September 2025. Skalicky brings over 30 years of leadership experience in pharmaceutical, biotechnology, and healthcare sectors. Most recently, he served as president of Eversana, where he designed the industry's first fully integrated commercialisation model. Previously, he held senior roles at Syneos Health and PharmaNet. As group CEO, Skalicky will lead Clinigen's growth, building on its position across clinical trial services, strategic staffing, and global compassionate use programmes. Chairman Paul Carter praised Skalicky's expertise in commercialisation, patient access, and pharmaceutical services, noting his ability to scale global organisations.
Clinigen has secured world-first pharmaceutical approval in Japan for Prolacta Bioscience's PreemieFort Enteral Solution, a human milk-based fortifier. The product is indicated for nutritional management of very low birth weight infants and neonates with weight gain failure. Whilst regulated as infant formula in the US and Europe, PreemieFort became the first human milk-derived product approved as a prescription drug in Japan. The approval was supported by data from the JASMINE Phase III clinical trial in very low birth weight infants. Clinigen served as exclusive licensee and marketing authorisation holder, working with regulators to establish a pharmaceutical pathway where none previously existed. The achievement is particularly significant given Japan's rigorous regulatory standards and status as a global leader in neonatal care.
Acquisition of CSM for initial consideration of $150 million
UK: triton-backed Clinigen acquires SSI Strategy from Amulet Capital.