MMS
Senior Quality and Compliance Specialist - Homebased, UK (GCP & CRO Experience)
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About MMS
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry-best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
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Job Specific Skills
- Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates
- Understanding of how to plan, prepare, and conduct GCP audits independently
- Proficient in authoring and managing audit documents independently
- Develop CAPA plans and contribute to resolution of audit findings independently
- Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently
- Assists in other duties relating to overall compliance within Quality and Compliance department, as requested
- Must be willing to travel up to 30% of the time for audits within the UK/EU
Requirements
- College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduate
- Minimum of 5 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
- Expert knowledge of scientific principles and concepts.
- Proficiency with MS Office applications
- Hands-on experience with clinical trial and pharmaceutical development preferred
- Good communication skills and willingness to work with others to clearly understand needs and solve problems
- Excellent problem-solving skills
- Good organizational and communication skills
- Proficient with 21 CFR Part 11, FDA, and GxP requirements
- Expertise within CROs and scientific and clinical data/terminology, and the drug development process
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