Senior Quality and Compliance Specialist (Remote)

MMS; United States; Remote; USD 100,000 - 125,000; Full time

Job summary

An innovative data-focused CRO is seeking a Senior Quality and Compliance Specialist to ensure adherence to regulatory standards. This role involves conducting GCP audits, managing compliance documentation, and developing corrective action plans. The ideal candidate will have extensive experience in the clinical research field, strong problem-solving skills, and a solid understanding of FDA regulations. Join a company dedicated to improving lives through high-quality service and technology solutions, and be part of a collaborative team that values diverse talent and continuous learning. This is a fantastic opportunity for those looking to make a significant impact in the pharmaceutical industry.

Qualifications

• Minimum of 5 years’ experience in GCP regulated industry.
• Expert knowledge of scientific principles and concepts.

Responsibilities

• Conduct GCP audits independently and develop CAPA plans.
• Monitor vendors and clinical investigator sites for compliance.

Skills

Regulatory Compliance Knowledge

GCP Auditing

Audit Document Management

CAPA Development

Vendor Monitoring

Communication Skills

Problem-Solving Skills

Organizational Skills

Education

Bachelor's Degree in Scientific or Medical Discipline

Master's Degree (preferred)

Tools

MS Office

Job description

Senior Quality and Compliance Specialist (Remote)

Join to apply for the Senior Quality and Compliance Specialist (Remote) role at MMS.

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.

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.
• 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 30% of the time for audits within the US.

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 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor).
• Expert knowledge of scientific principles and concepts.
• 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.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing