Senior Quality and Compliance Specialist
2 weeks ago
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, 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 and conduct GxP audits independently.
- Ability to support clients with development or refinement of Quality Management Processes or Systems
- Project management as it relates to quality and compliance activities
- Proficient in authoring and managing audit documents 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 US; must also be willing to travel internationally as needed
- 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 to 7 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor)
- Expertise within CROs, scientific and clinical data/ terminology, and the drug development process
- Experience with project oversight including but not limited to; document management, vendor qualifications, training management
- 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 applicable regulatory requirements
- Must have strong technical writing skills
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