Quality Assurance Manager

Rockville, MD
May 18, 2017
May 22, 2017
Full Time
POSITION SUMMARY:The Quality Assurance (QA) Manager is responsible for providing support to the development, implementation, and continuous improvements of Aeras Quality Management Systems (QMS) with focus on pre-clinical and clinical immunology Good Laboratory Practice (GLP)/Good Clinical Laboratory Practice (GCLP) compliance programs. The incumbent will also be required to assist with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) activities, as appropriate.The incumbent will be responsible for auditing studies conducted at Aeras preclinical and clinical immunology laboratories, and/or outsourced to vendors, to assure management that facilities, equipment, personnel, methods, practices, records and controls are in compliance with the regulatory regulations and global standards. The incumbent will be the GCLP and GLP subject matter expert within the company, and assist in training staff on GCLP, GLP and some GCP aspects. Works under minimal supervision; requires ability to exercise good judgment. Discretion in handling assigned responsibilities, including the ability to resolve problems. Functions are to be completed in a timely manner with acceptable quality. The position will be based in Rockville, MD, USA.ESSENTIAL DUTIES AND RESPONSIBILITIES:Primary Duties and responsibilities shall include, but are not limited to the following:Oversee and facilitate the development, implementation and continuous improvement of preclinical and clinical immunology QMS section, which includes procedures, processes, systems and training development and reviewMaintain a copy of master schedule of all laboratory studies conducted internally at Aeras facilities and outsourced to vendors, partners or collaboratorsMaintain final approved preclinical and clinical immunology protocols as part of inspection readinessIdentify emerging regulatory and quality issues related to GLP/GCLP and lead implementation strategyCompile and submit periodic trend report to management which includes incidents, protocol and procedure deviations, and corrective and preventive actions takenMonitor and conduct, audit schedules at intervals adequate to assure the integrity of the study and maintain written records of quality assurance activitiesEnsure close communication and interaction with operations teams to facilitate development and closure of corrective and preventive actions for audits, deviations and investigations according to defined timelinesOversee and manage GLP inspections and external audits, as appropriateReview final study report to assure that such report accurately describes methods and SOPs, and reported results accurately reflect the raw data of preclinical laboratory studyParticipate in onboarding activities by providing training on Aeras QMSAssists in daily management activities of quality assurance document control team, including mentoringQualificationsMINIMUM QUALIFICATIONS AND REQUIREMENTSBachelor of Science in a scientific disciplineMinimum six (6) years of experience in GCLP and/or GLP activities , including four (4) years in GLP Quality Assurance role, in a life science company with exposure to different phases of clinical trials essentialAnalytical with practical knowledge on how to identify key performance metrics for quality indicators to set targets for maintaining compliance and identifying areas of improvementExperience in auditing in GLP/GCLP environmentExperience and understanding of local and international regulationsPossess a blend of business and scientific knowledge, as well as interpersonal skills; effective communication (both orally and in writing), demonstrated ability to influence outcomes of the decision making process , excellent presentation and listening skillsMust be independent decision maker and be able to demonstrate strong leadership skillsMust maintain a professional demeanor, as well as a pleasant manner and positive "can-do" attitude while developing and maintaining communications in a cooperative and collaborative manner with all levels across functional teams both internally and externallyFlexibility to change priorities and be comfortable with the changing deadlines to meet organization needs when requiredMust be detail-orientated, with the ability to work on multiple projects with overlapping schedules and prioritiesHighly motivated and a self-starter; demonstrated ability to work independently, as well as in a team while exercising discretion; takes initiative to resolve problemsExcellent computer literacy skills with expertise in Microsoft OfficeFollows all company safety practices, Standard Operating Procedures (SOP's) and policiesPREFERRED QUALIFICATIONSExperience of vaccines a benefit

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