Regulatory Affairs Manager/Quality Assurance

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Posted by: LMI on Sep 14, 2020


Frederick , MD

Job Description:

LMI is looking for a Regulatory Affairs Manager / Quality Assurance Consultant to support one of our primary customers.

Successful candidate for this position will perform the following duties:

Provide expert analysis and advice on the development, management, and improvement of a regulatory organization. Define and document regulatory strategy; provide analysis of candidate maturity; and draft, review, and approve requisite target product profiles of candidates considered promising for advanced development. Advise on, review, and evaluate the presentation of data standards in accordance with current regulatory guidance. Implement quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities. Define, draft, and implement the regulatory and quality infrastructure necessary to support all research and development efforts. Participate as a regulatory point of contact during product development efforts in order to facilitate cross-communication. In addition, the contractor shall present, orally and in writing, the outcome of these efforts in a timely manner. Determine which studies require GLP and provide contract oversight, as well as those studies not requiring GLP yet appropriate quality levels. Participate in medical systems acquisition management activities (e.g., IPT meetings, reviewing acquisition documentation, etc.) and present the outcome, orally and in writing, in a timely manner. Travel for presentations and seminars, and conduct and provide oversight of supplier evaluation visits (e.g., due diligence, mock 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 In addition, provide expert analysis and advice in the follow-up actions (e.g., formal reports, updates of related databases, etc.) of these audits and inspections.
Assist Headquarters elements in their understanding of the scientific complexity of the research and development efforts and compliance with regulatory and quality regulations surrounding those efforts. Analyze any regulatory issues, providing corresponding risk assessments and guidance on developmental paths forward and presenting/defending these analyses orally and in writing. Apply regulatory analyses based on FDA regulations, regulatory policies, and DoD regulations and guidance across the JPEO-CBRND Medical portfolio and present findings, orally and writing. Assess the JPEO-CBRND Medical portfolio for sound science and regulatory compliance with FDA regulations and provide assessment and analysis of associated risks, orally and in writing, in a timely manner. Format regulatory submission in the eCTD format. Assist the Risk Manager in risk identification and analysis, as well as development of mitigation plans. Plan (i.e., develop meeting agendas), participate in, and provide support (i.e., develop meeting minutes and track action items) to the RA/QA working group.
Review and assess JPEO-CBRND Medical portfolio documents and relevant medical science and technology program documents to assure alignment to advance development efforts (e.g., being able to develop a new drug under FDA rules, and be an advocate for drug development based on FDA rules/regulations, etc.). Attend relevant briefings, presenting the outcome and providing reviews and assessments, orally and in writing, in a timely manner. Assist in the design, development, and implementation of an electronic document management system that will manage (i.e., draft, edit, and approve) documentation, as well as serve as a repository for approved documents with search and retrieve capabilities. Provide expert analysis and advice in all areas of clinical QA programs that support clinical and non-clinical operations, ensuring that clinical trials and non-clinical studies are conducted in accordance with applicable regulations and ICH guidelines for GCP/GLP and are in compliance with all internal procedures and protocols. In addition, the contractor shall provide expert quality advice in clinical and non-clinical study team meetings. Provide expert quality assurance analysis and advice for GMP, industry best practices, strategic relations, and medical transitions in the areas of biopharmaceutical facilities and manufacturing processes (to include BSL3), medical countermeasures development, and licensed products. 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 organizational quality 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. Review and comment on the following: Assessments to identify direct and indirect impact systems and determine whether appropriate documentation is being appropriately generated, reviewed, and approved in design development Compliance requirements of the User Requirement Specification, Commissioning Plan, and Qualification Plan (e.g., Validation Master Plan - IQ/OQ/PQ) to ensure knowledge, expertise, and input in the areas of GMP, regulatory expectations, and Industry trends have been incorporated into the project early on (i.e., from design concepts under GEP control, to a smooth GEP/GMP transition, and then into a full GMP compliance environment of a quality managed system) Compliance requirements for the quality change control process and documentation management for direct impact systems, as well as changes that may alter the impact assessment of indirect impact systems, a change in the design concept, or a change that results in a deviation from the User Requirement Specification All documentation requiring Quality Unit sign-off in support of product manufacturing (e.g., product development, scale-up, production, etc.), testing (e.g., batch testing and release, etc.), and quality operations (i.e., investigations, change controls, CAPA systems, facilities/equipment, materials, bio-production, formulation, filling, packaging/labeling, quality control testing, and shipping) to ensure quality systems and procedures are adequate for compliance with all applicable laws, regulations, and organizational quality standards All documentation requiring CQA sign-off, including clinical studies (i.e., investigator brochures, clinical study protocols, case report forms, informed consent forms, safety reports, and clinical study reports) and other documents (e.g., CRO quality agreements, GCP audit plans, IND annual reports, pharmacovigilance plans, etc.) All applicable assessments, plans, procedures, rationales, specifications, protocols, qualifications, drawings, schedules, records, and reports Non-clinical study reports supporting IND submissions Clinical study reports and Integrated Summary of Safety / Integrated Summary of Effectiveness (ISS/ISE) data Pre-IND Types A, B, and C information for FDA submissions/requests Standard operating procedures governing document management, quality systems, and FDA submissions

Qualified candidate should possess the following:
At least a Master's degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience. Or alternatively, a Bachelor's degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience. Preferred candidate will possess a Regulatory affairs certification 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 the JPEO-CBRND Medical portfolio. Possess expert knowledge in regulatory affairs and quality assurance as it relates to pharmaceutical development, as well as previous experience applying this knowledge to the development of a regulatory/quality organization conducting non-clinical and clinical studies and manufacturing development efforts. In addition, the contractor shall be capable of applying this expert knowledge to complex technical problems with minimal supervision. Possess knowledge of GLP. Maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self-starting. Demonstrated ability to effectively communicate, both verbally and in writing, to customers, colleagues and external stakeholders.

EEO Statement
LMI is an Equal Opportunity Employer-all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

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About LMI

LMI is a consultancy dedicated to improving the business of government, drawing from deep expertise in advanced analytics, digital services, logistics, and management advisory services. Established as a private, not-for-profit organization in 1961, LMI is a trusted third party to federal civilian and defense agencies, free of commercial and political bias.

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