{"id":3875330,"url":"https://alion.io/job/qrc-group-project-manager-3","title":"Project Manager","company":{"id":4444,"name":"QRC Group","domain":"qrcgroup.com","url":"https://alion.io/company/qrcgroup","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":null},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Aibonito, Puerto Rico"],"countries":["PR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 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through to FDA submission.\nLead and manage complex projects related to the development, commissioning, process development and validation of aseptic pharmaceutical or medical deviceproducts.\nEnsure compliance with FDA and other regulatory bodies’ requirements, particularly in aseptic areas and sterile manufacturing processes.\nPrepare and review documentation for FDA submissions and other regulatory filings.\nWork closely with internal stakeholders (R&D, quality assurance, operations, regulatory affairs, etc.) to ensure cross-functional alignment and timely execution of project milestones.\nManage risk assessments and mitigation strategies to address project challenges.\nConduct periodic project reviews and provide status reports to senior management, highlighting key project milestones, risks, and issues.\nBachelor’s degree in Engineering, Life Sciences, or a related field (Master's degree preferred).\n8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry, with a focus on aseptic areas and FDA submissions.\nPMP certified preferable.\nProven track record of leading projects through FDA submissions.\nStrong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic processing, validation protocols, and good manufacturing practices (GMP).\nExperience with process validation, cleaning validation, and equipment qualification in aseptic manufactur\n All your information will be kept confidential according to EEO guidelines.","description_format":"text","description_chars":2176,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Healthcare & Life 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