Quality Management Specialist
A global pharmaceutical company is recruiting for a Quality Management Specialist. The role based in Berkshire, will require supporting the Quality Management Lead for the biostats group in developing and maintaining quality systems and procedures within the biostatistics group.
- Provide input into compliance infrastructure development by creating and revising appropriate Quality and Compliance policies, SOPs and processes
- Work as part of a cross functional team within the group, building relationships with stakeholder groups and aligning on GCP standards across
- Communicating Quality initiatives from transversally to benefit the wider business
- Develop and apply quality compliance initiatives into the community
- Contribute/lead meetings and discussions on GCP, with focus on Statistical and programming activities
- Staying abreast with GCP and industry trends. Sharing key information gathered via professional associations and conferences within the Practice
- Process mapping, and identifying any training needs of the statistics Community
- Identify/develop efficiency approaches/methodologies/tools with Quality centric benefits
- Ensuring the continuous development of the statistical expertise and improvement of the quality and compliance of the support given by
Skills and Requirements
- Strong pharmaceutical experience, preferably in a Statistical or Programming in Clinical Trials (but would consider Data Management, Quality Management, or Project Management applicants)
- Experience in audits/inspections (advantage)
- Excellent working knowledge of GCP, proficiency of regulatory and ICH guidelines
- Excellent planning and organisation skills, through a methodical mindset
- Detail oriented with problem-solving skills, including application of root cause analysis
- Ability to work effectively in a fast-paced environment with sense of urgency and proactivity
- Excellent communication and interpersonal skills - ability to effectively communicate (oral and written) to sites, partners, vendors, and all levels of the organization
- Ability to present complex projects and issues to senior management
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams at 0203 854 3893 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.