Senior Quality and Compliance Specialist (Remote)
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 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
Recommended Jobs
Senior Portfolio Associate, CMF
As a Senior Portfolio Associate on Stryker’s C raniomaxillofacial ( CMF) Upstream Marketing team, you will help shape the future of a high‑impact implant portfolio that directly improves patients’ l…
Landscape Maintenance Crew Member
Wolverine Lawn Services is seeking dedicated Grounds Maintenance Crew Members and Crew Leads to join our growing team serving West Michigan. As a year-round provider of commercial and residential gro…
Parts Department Internet Order Processor (Seasonal; Part-Time)
Job Description Job Description Our Fox Powersports - Grand Rapids location is looking for a Part-Time / Seasonal Internet Order Processor to support our busy Parts Department during peak season.…
Associate Product Manager - Integrations
Associate Product Manager — Integrations Remote-Primary Hybrid (Bath, MI Headquarters) • Full Time • Entry to Early Career Who Are We Looking For? BS&A Software, established in 1987, stands…
Field Technician
Summary EchoStar is reimagining the future of connectivity. Our business reach spans satellite television service, live-streaming and on-demand programming, smart home installation services, mo…
Body Shop Technician
Company Summary: With over 70 years of business in the Great Lakes Bay Region, our family owned and operated dealerships are about more than making the sale. Operating two dealerships providing Cadi…
Real Estate Agent / Portfolio Leasing Specialist
Job Description Job Description Are you an experienced, licensed realtor looking for steady income, built-in clients, and long-term growth opportunities ? We are an experienced property manageme…
Associate Sales Representative
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Radiometer, one of Danaher's 15+ operating …
Customer Service Representative
Job Description Job Description Benefits/Perks: Paid time off (vacation and/or sick days) Growth potential Salary plus commission/bonus Simple IRA Flexible hours License reimburs…
Facilities Manager - Delta Township Area
Job Description Job Description Facilities Manager | Delta Township, MI Salary Range: $90,000 - $137,000 depending on experience Are you ready to take on a challenging and rewarding op…