Senior Quality and Compliance Specialist - Homebased, UK (GCP & CRO Experience)

MMS Holdings Inc; Manchester; On-site; GBP 65,000 - 85,000; Full time

Job summary

MMS Holdings Inc. is seeking a GCP Auditor to join our quality and compliance team in the UK. You will plan, conduct, and report on GCP audits across CRO networks, ensuring adherence to regulatory standards.

Responsibilities include authoring audit documents, developing CAPA plans, monitoring vendor and site activities, and traveling up to 30% within the UK/EU to ensure quality processes are followed. Strong communication and problem-solving skills are essential to collaborate with

Qualifications

• Requires college degree or 7 years of related GCP experience.

Responsibilities

• Plan, prepare and conduct GCP audits independently.
• Author and manage audit documents independently.
• Develop CAPA plans and drive resolution of findings.
• Monitor vendors and sites to ensure quality and regulatory conformance.

Skills

Regulatory updates

GCP audits

Audit document management

CAPA development

Vendor/site monitoring

Travel for audits

21 CFR Part 11 knowledge

Education

Bachelor's degree in scientific/medical/clinical discipline

Masters preferred

Tools

MS Office

Job description

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 a 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.

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 andconduct GCP auditsindependently.
• 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 inGCP 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.