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Senior Quality Associate
2 months ago
Senior Quality Associate (Cambridge, UK)
Cycle Pharmaceuticals is looking for an enthusiastic and talented team player to join its growing Quality Department as a Senior Quality Associate.
The role will be responsible for assisting the Quality Manager to oversee and support the overall quality and compliance activities of pharmaceuticals distributed by Cycle. As Senior Quality Associate , you will be focusing mainly on the branded generic portfolio, acts as Good Distribution Practice (GDP) SME to internal stakeholders – offering quality/compliance guidance, ensuring activities are in compliance with regulations and support the Quality Manager and the Responsible Person.
You will build your internal network and contribute to cross-functional project teams. Having the opportunity to participate in a range of company projects, you will leverage your transferable skills to make a real difference to our growth plan and patients we support.
This role interacts internally with key areas such as Regulatory - Labelling and Pharmacovigilance, Supply Chain, Project Management, Legal and Finance. Externally this position interacts with product suppliers, distributors and partners, as well as regulatory agencies responsible for licensing and approvals.
Coaching and mentoring to support continuous learning and professional development will be provided and tailored to individual needs.
We are a pioneering pharmaceutical company, reimagining how drugs and services can benefit patients with rare disease to make their lives easier and improve their quality of life. By collaborating with academic communities and using the latest cutting-edge pharmaceutical technologies, we translate innovations into medicinal products that patients and caregivers actually desire. We deliver the required medicine with the minimum impact on daily routines and, just as importantly, provide individualized support services to patients, families, carers and the healthcare professionals community.
Cycle has three core areas of pharmaceutical development and work across rare metabolic, immunological and neurological genetic conditions: improving drugs – optimizing an existing drug; Job Title: Senior Quality Associate
Cycle Pharmaceuticals Ltd
This is a full-time position within the Quality department, working in our Cambridge office.
Overseeing WDA authorised activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP.
Circulate Quality Agreements with new 3rd party / contract organisations as required.
Investigate complaints and manage deviations.
Support, review and approve order packs to ensure conformance to appropriate SOPs, GDP and applicable regulatory requirements.
Compile data for reports and presentations, provides data interpretation draws conclusions.
Support launch activities namely quality risk assessments, drafting and updating QTAs and any other quality activities required.
Keeps abreast of GDP requirements as described in applicable worldwide regulations.
Support project teams as the Quality SME, for projects you are nominated as QA Lead.
The following skills and experience will be important in helping set you up to succeed and thrive in this role:
PhD in a relevant scientific field is desirable
Working experience in a Pharmaceutical Quality System, ideally in pharmaceutical wholesale distribution with oversight of various suppliers and customers and with a general oversight of the Quality Management System.
Five years+ working experience in Quality, specifically GDP environment.
Quality focused.
Mentoring, coaching and training that will give you the opportunity for personal and professional development.
Help shape the culture and future of an emerging pharmaceutical company with a grand vision.
Competitive salary based on experience
~ Performance based bonus
~ Opportunity to join a fast growing and ambitious business
~ Company pension scheme
~100% employer paid membership for Private Health Insurance
~ Life and Critical Illness Insurance
~ Corporate Gym membership
~ Regular team building events and an agile working environment
Cycle Pharmaceuticals embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
