MMS Holdings Inc. Senior Regulatory Compliance Manager (Pharma Industry) in Charleston, South Carolina
MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience 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 was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
Roles & Responsibilities:
Provide oversight and participate in the planning, preparing and conducting investigator site, process, quality system, computer system, vendor qualification audits and other types of clinical trial and pharmaceutical-related audits as required. Report findings to the auditees and/or client, as required per project, agreement/contract. Provide mentorship to others conducting auditing activities.
Develop Corrective and Preventive Action (CAPA) plans, and facilitate resolution of audit findings.
Write audit plans, reports and other required audit documentation. Coordinate internal and external reviews and finalize documents according to project timelines.
Develop response letters to inspectional findings, and coordinate with client/inspected facility for submission to regulatory authority.
Perform internal quality assurance (QA) audits (including document and process audits) per procedure, as needed.
Perform peer review (QA) of audit plans, reports and other audit documentation and provide input and feedback.
Serve as internal GxP compliance subject matter expert, advising staff, developing training and providing expert consulting on regulatory compliance, monitoring processes, and application of new regulations and guidances to internal work processes. Provide mentorship to other MMS auditors to promote expanding their areas of auditing expertise.
Assist with business development and client capabilities as needed.
Train and provide technical oversight for auditors, including internal and TSP staff.
Develop and maintain SOPs, work practices, forms and other documentation and training materials related to GxP compliance and auditing services.
Provide expert consulting on MMS regulatory compliance monitoring processes and application of new regulations and guidances to MMS work processes.
Develop and lead training session?s internally/externally regarding audit or inspection readiness.
Participate and present on GxP related topics at external industry events, user groups, etc.
Independently train via self-study and self-practice, and explore advanced topics related to GxP regulatory compliance, auditing and process evaluations.
Provides leadership, mentor, and develop personnel by maintaining a positive work environment
Directs, Manages, and Oversees the daily activities of compliance team members
Responsible for the professional development of colleagues
Must have hands-on independent GxP Auditing Experience.
Bachelor?s degree in Biomedical, Nursing or related Life Science discipline required. Master?s degree or higher preferred.
Minimum 10 years of related experience or relevant pharmaceutical, health authority and/or CRO experience in a Quality Assurance department or GxP auditing role.
Minimum 5 years of experience managing direct reports
High level knowledge of drug development processes with the ability to apply drug development knowledge during GxP audits and process evaluations.
Expert knowledge of GxP guidelines as well as applicable government regulations related to pharmaceutical product development and clinical trial regulation.
Understanding of scientific, medical, and/ or clinical data.
Excellent, demonstrated verbal and written communication skills
Working knowledge of QC practices
Proficient with MS Office applications
Ability to travel both domestically and internationally as required for project work
Excellent organizational and communication skills and detail-oriented
Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
Familiarity with ISO 9001:2015 and ISO 27001:2013 standards.