Regulatory Affairs Manager - Clearance Desired

Overview

LMI is seeking an experienced Regulatory Affairs Manager to support our Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear (JPEO-CBRND) Regulatory Affairs and Quality Assurance (RAQA) client at our Ft. Detrick, MD location. Will serve as lead auditor for quality audits (GMP & GLP) of developing and manufacturing investigational countermeasures for MCS. This position can be performed remotely with occasional travel to the client site.

LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.

Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

Responsibilities

• Provide expert analysis and advice on the development, management and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and organizationalquality standards in support of GXP activities.
• Build and maintenance of Quality KPIs/Metrics, and Documentation and Data Controls Programs for maintaining compliance to the QMS regulations, guidelines and the QM/RA organization directives, and that QMS documentation is effectively implemented, controlled, maintained, stored, archived, protected and retrievable.
• Provide advice and aid in the implementation of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.
• Assess results and progress relative to objectives across projects and communicate periodically/as needed to relevant leadership and stakeholders through the conduct of supplier evaluation visits (e.g., due diligence, audits, vendor qualifications, etc.). This will include the following:
• Inspection of contract laboratories or other facilities, providing data in support of GLP studies to assure compliance with GLP guidelines, applicable protocols, and SOPs
• Periodic facility audits of facilities, equipment, and records required by GLPs
• QMS audits of ISO/FDA elements related to the control of documents and data
• Regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections
• GCP training and the development and maintenance of GCP-related quality systems
• GCP compliance audits of investigator sites, CRO facilities, and vendors, including clinical sample labs in accordance with audit plans
• Internal and external current GMP audits in support of the supplier evaluation program to identify and evaluate all risks
• Remain flexible to changing priorities and ideas while keeping project milestones on track.
• Propose and implement solutions to critical problems by creating actionable strategies and implementation plans to reallocate resources or efforts as required, as well as oversight plans that use metrics for monitoring progress.

Qualifications

• Required: Master's degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Business, Technical or Medical Writing, or a related discipline, as well as eight (8) years of relevant experience; or PhD in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Business, Technical or Medical Writing, or a related discipline, as well as six (6) years of relevant experience serving as a Regulatory Affairs Manager performing:
  • Laboratory and facility inspections in support of GLP studies
  • Facility audits as required by GLPs
  • QMS audits of ISO/FDA elements
  • Regulatory agency inspections
  • GCP training
  • GCP compliance audits
  • Internal and external current GMP audits
• Be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self-starting.
• Preferred: Certification in Regulatory Affairs or other certification relevant to medical product development and/or audit, is desired and will be at no cost to the Government.
• Possess and maintain a mastery of FDA regulations, inferences, and regulatory requirements, and have the capability to interpret and apply them to COVID-19 Product Development and Fielding efforts.
• Possess expert knowledge in regulatory affairs and quality assurance as it relates to pharmaceutical development, as well as previous experience applying this knowledge in a regulatory/quality organization providing support throughout the product development lifecycle including pre-clinical, non-clinical and clinical study development and implementation, and medical product manufacturing development efforts. In addition, candidate shall be capable of applying this expert knowledge to complex technical problems with minimal supervision.
• Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).