We are recruiting for a Senior Quality Associate (Pharmaceutical Development) based in Cambridge (UK). This is an exciting and unique opportunity to join Cycle at a very important period of growth. We are looking for a self-starter, entrepreneurial and commercially minded individual who is not afraid of challenges and that is passionate about making a difference to patients’ lives.
The purpose of this role is to oversee and support the overall quality and compliance activities during the product development life cycle processes and to ensure quality oversight of our CMOs during product development including manufacturing, testing activities, and also supporting the release of Investigational Medicinal products for our company.
The ideal candidate will act as QA GMP expert to internal stakeholders- offering GMP quality/compliance guidance and to ensure R&D activities are in compliance with regulations and will report directly to Head of Global Quality.
- Oversee suppliers and third-party vendors to ensure compliance with company and GMP standards.
- Prepare Quality Agreement with new 3rd party / contract organisations as required by the development team.
- Investigate complaints/manage deviations and out-of-specifications.
- Perform and reviews related change controls and CAPA’s.
- Assist in audits to ensure compliance to SOPs, GMPs and applicable regulations.
- Support review and approve CMC and non CMC related documents, including product specification, batch documentation, CofAs, stability data, test method, analytical validation report, method transfer, process validation protocol and reports and packaging documentation, to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
- Support clinical supplies / pilot batches activities, including providing approval and release for clinical supplies / pilot batches and registration samples.
- Actively communicate and collaborate with functional areas to develop a strong working relationship and represents department on cross functional teams.
- Support product recalls and stock recoveries as appropriate.
- Identify compliance gaps and make recommendations for continuous improvement.
- Creates and maintains assigned SOPs.
- Generally, follows standard procedures and consults with Head of Quality to ensure resolution of exceptions.
- Compiles data for reports and presentations, provides data interpretation draws conclusions.
- Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
- Additional activities as assigned by the Head of Department.
- BS/MS degree in chemistry, biology, pharmacy or related scientific discipline.
- Minimum of five years of pharmaceutical experience in R&D QA, supporting the GMP manufacture of investigational medicinal products.
- Experience in solid dosage forms is preferred
- Experience in Quality Assurance in pharmaceutical GMP environment is required
- Proficiency in cGMPs, and other regulatory guidances
- Excellent People, Communication and Technical Writing Skills
- Knowledge of computer programs such as Excel, Word, Power Point
- Ability to work on multiple projects and priorities in a concurrent manner
- Demonstrated ability to work independently and to drive the completion of tasks.
- Team player, learning from and helping others overcome obstacles.
- Effective communication, negotiation, problem-solving, and interpersonal skills are necessary to perform job responsibilities.
Working Conditions & Environment
The role is full time, and office based in Cambridge, UK. However, with the current COVID-19 situation, we may require you to work from home for all or part of the week.
Please send your CV and cover letter to:
Rob Holton – firstname.lastname@example.org
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.