Senior Quality and Compliance Specialist (Remote)
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Job Location:
Austin, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
About MMS
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 more information follow MMS onLinkedIn.
Job Specific Skills:
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 more information follow MMS onLinkedIn.
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 GxP auditsindependently.
- 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 inGCP 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
Required Experience:
Senior IC
About Company
MMS Holdings is a leading global data-focused CRO (Clinical research organization) & technology enabled clinical research and health data analytics solution company that supports the pharmaceutical, biotech, and medical device industries.
