[Hiring] Senior Quality and Compliance Specialist @MMS

Role Description

MMS is seeking a qualified candidate to maintain a strong understanding of regulations and guidance as they pertain to compliance. The role includes:

• Understanding how to plan, prepare, and conduct GxP audits independently.
• Supporting clients with the development or refinement of Quality Management Processes or Systems.
• Managing project activities related to quality and compliance.
• Authoring and managing audit documents independently.
• Monitoring vendors and clinical investigator sites to ensure processes are followed and quality is maintained.
• Assisting in other duties related to overall compliance within the Quality and Compliance department, as requested.
• Willingness to travel up to 30% of the time for audits within the US and internationally as needed.

Qualifications

• College graduate in scientific, medical, clinical discipline, or related experience; Masters preferred.
• 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 (e.g., 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 document management, vendor qualifications, and 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.
• Strong technical writing skills.

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 skills.
• Good organizational and communication skills.
• Proficient with applicable regulatory requirements.
• Must have strong technical writing skills.

Benefits