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Senior Quality Associate

3 months ago

Cambridge, United Kingdom Cycle Pharmaceuticals Full time

Senior Quality Associate (Cambridge, UK)


The Opportunity


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 be working across different therapeutic areas including metabolic, immunology and neurology, and investigating a range of different technologies and dosage forms. 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.


Job Interactions & Interface:


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.


The Cambridge team is relatively small but highly dynamic, and the work environment is representative of an expanding company, hence requiring an adaptive and pragmatic mindset. Coaching and mentoring to support continuous learning and professional development will be provided and tailored to individual needs.


Our Company


At Cycle, we believe that Every Single Patient Matters, this is at the heart of why we work, and we’d love for you to share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.


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. Cycle, as a company, works closely with patient groups and healthcare professionals to understand the unmet needs of patients and their carers. 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; repurposing drugs – creating a new indication for an existing drug; and generics – reinstating generic drugs, previously available in the market. These three areas of focus are underpinned by formulation technology – using new drug delivery technologies to improve the efficacy and effectiveness of drugs, allowing us to give patients greater freedom and choice.



Job Title: Senior Quality Associate


Cycle Company: Cycle Pharmaceuticals Ltd

Position Summary: This is a full-time position within the Quality department, working in our Cambridge office.



What you will be doing


Technical responsibilities:

  • Overseeing WDA authorised activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP.
  • Overseeing suppliers and third-party vendors to ensure compliance with company and applicable GDP standards.
  • Circulate Quality Agreements with new 3rd party / contract organisations as required.
  • Investigate complaints and manage deviations.
  • Perform and reviews related change controls and CAPA’s.
  • Support, review and approve order packs to ensure conformance to appropriate SOPs, GDP and applicable regulatory requirements.
  • Support product recalls and stock recoveries, as appropriate.
  • Follow standard procedures and consult with the line manager to ensure resolution of exceptions.
  • Compile data for reports and presentations, provides data interpretation draws conclusions.


Departmental responsibilities:

  • Actively communicate and collaborate with functional areas to develop a strong working relationship and represents department on cross functional teams.
  • Support launch activities namely quality risk assessments, drafting and updating QTAs and any other quality activities required.
  • Identify compliance gaps and make recommendations for continuous improvement.
  • Create and maintain assigned SOPs.
  • 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.


What will enable you to thrive


The following skills and experience will be important in helping set you up to succeed and thrive in this role:


  • BSc / MSc degree in Life Sciences or equivalent
  • 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.
  • Proficiency in Good Distribution Practice.
  • Experience in CSV and being familiar with DSCSA requirements is highly desirable.
  • Excellent written and oral communication
  • Ability to work in a proactive and autonomous manner, as well as being part of a team.
  • Excellent time management skills with a high level of attention to detail, including when under pressure.
  • Ability to create and maintain strong working relationships across the organisation and with external partners.
  • Enthusiasm and personal initiative to solve problems, a self-starter with ability to work unsupervised.
  • Able to deliver against target dates.
  • Strong analytical, organisational and problem-solving skills, and the ability to think-outside the box.
  • Quality focused.
  • Result-oriented.


What makes this role special


  • Seek to have a profound impact on patients and their families.
  • Work across a range of different disease states.
  • 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.
  • Work with a growing team of experienced professionals.
  • Learn from a strong leadership team with a proven history of success.


What can we offer to you


In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:


  • Competitive salary based on experience
  • A collaborative high performing work environment
  • 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


Applications


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. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.