Gmp Compliance ManagerThis position is responsible for ensuring a state of continuous GMP compliance of Client's services and activities. This requires a combination of regulatory knowledge, attention to detail, effective communication, and a commitment to continuous improvement with the goal of achieving compliance to applicable regulatory requirements and obligations throughout the organization and ensuring that appropriate control measures are in place.Key Accountabilities and Responsibilities:Effectively communicates and proactively seeks resolution to compliance matters in accordance with internal and regulatory requirementsCommunicates the status of unresolved compliance matters to stakeholdersEnsures the completion of review/audit of daily reports including, but not limited to final reports, protocols, and nonconforming event reportsOversees controlled Quality documentsIdentifies areas for improvement to policies and processes, assesses effectiveness of current policies and processes, and recommends changesProvides professional and objective feedback to authors, study directors, technicians, and supervisors on quality and regulatory mattersDrafts, revises, and approves SOPsManages OOS and deviation events including but not limited to CAPA response reports, client notification, including tracking and reporting of OOS and deviationsManages customer complaints including but not limited to investigating and communicating CAPAs to effected partiesConducts and/or supports internal audits, client audits, and regulatory audits including, but not limited to coordinating audit scheduling, audit preparation, audit execution, audit response/resolution, and audit follow-upEstablishes and maintains Quality agreements with clients and suppliersSupports education and training on the business on compliance awareness developing and providing quality training, including, but not limited to, GMP orientation, ongoing quality training, and annual regulatory trainingConducts and/or supports Risk AssessmentsPrepares, maintains, analyzes, and presents metrics related to the quality systems and for tracking regulatory compliance of operationsBuilds collaborative team environment within the department and amongst other company departmentsLeads projects and implements quality initiatives in line with department and organizational goalsCompletes and reports on assignments within the agreed upon timeframeActs as a back up to Quality Lead on an as needed basisTrains and mentors department personnelSupervises departmental personnel including but not limited to scheduling, time off approvals, ensuring training requirements have been met, staff development, succession planning, and performance managementRemains current in the field by review of relevant regulatory and compliance literature and attendance at appropriate seminars and conferences.Additional duties as assignedAdditional Accountabilities and Responsibilities:Works independently and proactivelyAbility to adhere to a standard timeline and resolve issues in a timely mannerProactively communicates progress and furthers understanding amongst colleagues and supervisorsMeets testing timelines in a reliable and efficient mannerProblem solving and conflict resolution skills in a cross functional settingAbility to drive and meet project timelines individually and by coordinating the work of othersUpdates training materials and trains others as appropriateSubject matter expert in respective fieldMay serve as a delegated backup for senior staff when requestedPossesses working knowledge of regulatory environment and industry standardsCoordinates test record reviewRequirements:Bachelor's degree from an accredited college/university in microbiology, biology, or a relevant field5+ years' experience in the biotechnology industry with increasing scientific and leadership responsibilitiesAbility to handle multiple tasks and projects under deadline pressureAble to adapt quickly to changeStrong organizational and time management skillsHighly analytical with strong attention to detailExcellent verbal and written communication skillsA results-oriented team playerProficient with Microsoft Office Suite or related softwarePhysical Requirements:Prolonged periods of sitting on a chair, working at a desk and working on a computer and/or telephone