Principal Operational Compliance Lead

Are you ready to elevate your career to new heights? Do you possess the expertise to navigate the complex landscape of Operational Compliance? If so, we have an exciting opportunity for you! We are actively seeking a dynamic and experienced Principal Operational Compliance Lead to join our thriving team in Loughborough.

As a Principal Operational Compliance Lead, you will be overseeing compliance with EU and UK GXP/ISO standards at Aspire Pharma Limited, you will support and manage staff in their daily operations, ensuring proper training and goal achievements. You will handle responsibilities such as temperature mapping, sample control, FMD serialisation, stock management, batch release, controlled drug oversight, launch activities, returns assessment, and recall management. You will actively participate in internal audits and inspections, providing regular reports to senior management on company performance and addressing GXP/ISO compliance issues.

Hours of Work: Monday-Friday: 09:00- 17:00

Principal Operational Compliance Lead Requirements:

* Minimum 4 year's experience working in Quality Assurance with Medicinal Products and Medical Devices.
* Experience in Product Supply for a GXP/ISO business.
* Experience with Tracelink.
* Experience with QPulse and Business Central desirable.
* Excellent verbal and written communication skills, with the ability to communicate effectively within Aspire Pharma Limited, with Regulatory Authorities, Approved Bodies, Notified Bodies, vendors and customers.
* Team management skills and strong time/workload management, with experience managing hybrid teams (on site and remote) desirable.
* Good attention to detail.
* Proficient in MS Office and Adobe Acrobat.

Principal Operational Compliance Lead Benefits:

* Generous Pension Scheme.
* Life Assurance cover and Employee Assistant Program.

* 25 days' holiday plus Bank Holidays.
* Learning and Development opportunities.
* Excellent opportunities for progression.
* Fantastic Company events and celebrations throughout the year.

Meet the Organisation: Who We Are and What We Do

Aspire Pharma, is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.

In October 2022, Aspire Pharma and H.I.G. Capital completed the transformational acquisition of Morningside Pharmaceuticals and Healthcare who has a diversified portfolio of more than 100 products across a range of therapeutic areas.

As these two successful businesses continue the integration process, it is a truly exciting time to join this growing business. This acquisition will create a clear leader in the UK specialty pharmaceuticals market and a platform ready to drive rapid international expansion through both organic and inorganic approaches.

Ready to take the lead and make a significant impact? If you believe you're the perfect fit for the Principal Operational Compliance Lead role, don't wait - apply now!