Total Quality Senior Specialist jobs in Madison, WI

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. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. 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 GCP audits independently.
• Proficient in authoring and managing audit documents independently.
• Experience in reviewing and editing QMS related documents, i.e., SOPs, Work Practices, Forms, Training Materials, etc. 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 75% of the time for audits within the US and potential travel to Canada.

• 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. 
• Reputation as emerging leader in field with sustained performance and accomplishment.
• 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.