Senior Quality and Compliance Specialist
2 weeks ago
Senior Quality and Compliance Specialist (Remote) 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 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 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 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 skillsGood organizational and communication skills Proficient with applicable regulatory requirements Must have strong technical writing skills Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Information Technology Industries Wireless Services, Telecommunications, and Communications Equipment Manufacturing Referrals increase your chances of interviewing at MMS by 2x Sign in to set job alerts for “Senior Quality Specialist” roles. #J-18808-Ljbffr
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Remote Senior Quality
2 weeks ago
Canton Charter Township, United States MMS Full timeA leading clinical research organization is seeking a Senior Quality and Compliance Specialist to ensure compliance with quality regulations. This remote role requires expertise in GCP regulated industry and project management experience. Candidates should possess strong communication and problem-solving skills. The position offers a full-time engagement,...
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Senior Quality and Compliance Specialist
2 weeks ago
Canton Charter Township, United States MMS Holdings Inc Full timeAbout 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...
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Senior GxP Quality
2 weeks ago
Canton Charter Township, United States MMS Holdings Inc Full timeA global clinical research organization located in Canton Charter Township, Michigan is looking for a qualified candidate with expertise in regulatory compliance and GCP auditing. The role involves independent planning and conducting of audits, managing quality and compliance projects, as well as authoring audit documentation. Candidates should possess a...
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Senior Quality Assurance Specialist
4 weeks ago
Woodbridge Township, United States Katalyst Healthcares and Life Sciences Full timeJob Description: The Senior Quality Assurance Specialist is responsible for ensuring that computerized systems used in GxP-regulated environments are validated and maintained in compliance with applicable regulations. This role also ensures that data integrity principles are upheld throughout the system lifecycle, supporting quality assurance and regulatory...
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Senior Quality and Compliance Specialist
2 weeks ago
Canton, MI, United States MMS Full timeAbout 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...
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Senior Quality and Compliance Specialist
3 hours ago
Canton, MI, United States MMS Full timeAbout 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...
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Senior NAO Quality Leader: Product Quality
1 week ago
Plainsboro Township, United States Novo Nordisk AS Full timeA leading pharmaceutical company in Plainsboro Township is seeking a Senior NAO Quality, Product Quality Manager to oversee product quality assurance and maintain compliance with regulatory standards. The ideal candidate will have at least 7 years of experience in quality management, preferably within the pharmaceutical industry. Responsibilities include...
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FSQA Regulatory
2 weeks ago
Charter Township of Cascade, United States Kent Quality Foods Full timeAbout the Role We are seeking a detail-oriented and highly organized FSQA Regulatory & Systems Specialist to join our Food Safety and Quality Assurance team. This position plays a key role in supporting product labeling compliance and FSQA system management to ensure alignment with USDA/FSIS and FDA regulations. The Specialist will work collaboratively with...
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Bridgewater Township, United States Bausch & Lomb Full timeBausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global...
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Compliance Specialist
48 minutes ago
Meridian charter Township, United States Delta Dental of Michigan Full timeCompliance SpecialistTo provide support for the day-to-day operations and management of the Compliance Program with respect to Delta Dental of Michigan and its affiliates and/or subsidiaries.Primary Job Responsibilities:Implements initiatives to raise awareness of Company's Compliance Program including planning, developing and conducting education and...
