Senior Quality and Compliance Specialist (Remote)

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, 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

• Proficient in how to plan, prepare and conduct GCP audits independently, mentors others.
• Proficient in authoring and managing audit documents independently; mentors others.
• Maintains a strong understanding of regulations and guidance as they pertain to compliance; mentors other and advises on MMS updates related to regulatory updates.
• Proficient in authoring QMS related documents, i.e. SOPs, Work Practices, Forms, Training Materials, etc. independently; mentors others.
• Develop CAPA plans and contribute to resolution of audit findings independently; mentors others.
• Develop and maintain Service Line Information Management System (IMS) documents independently, mentors others.
• Assists in internal processes and documents QA audits per procedure independently mentors others.
• Lead and support business development and capabilities activities independently, mentors others.

Core Company Values

• Represent self and company in a professional manner and in line with core company values.
• Practice excellent internal and external customer service, communication, and team work.
• Support objectives and improvement efforts within department and organizationally.
• Comply with all applicable policies, procedures, and training requirements.
• Additional tasks as assigned by manager.

Requirements

• College graduate in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.
• Minimum of 3 to 5 years’ experience in a GCP auditing,
• Understanding of CROs, scientific & clinical data/terminology & the drug development process.
• Familiarity with 21 CFR Part 11, FDA, and ICH GCP requirements.
• 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.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Domestic travel required up to 50%-75% for vendor onsite audits

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