Regulated Pharmaceutical Projects Director
hace 22 horas
Overview:
">Qrc Group, LLC is a leading provider of contract manufacturing services to the pharmaceutical and medical device industries
">We are seeking an experienced Regulated Pharmaceutical Projects Director to lead and manage projects in our aseptic areas
">Job Description:
">The Regulated Pharmaceutical Projects Director will be responsible for developing project timelines, resource allocation plans, and budgets to ensure timely and on-budget delivery
">The successful candidate will have a strong background in project management, particularly in regulated pharmaceutical and medical device industries
">Responsibilities:
">- ">
- Develop project timelines, resource allocation plans, and budgets to ensure timely and on-budget delivery">
- Coordinate and oversee all stages of project execution from design through to FDA submission">
- Lead complex projects related to development, commissioning, process development, and validation of aseptic pharmaceutical or medical device products">
- Ensure compliance with FDA and other regulatory bodies' requirements">
- Prepare and review documentation for FDA submissions">
- Work closely with internal stakeholders to ensure cross-functional alignment and timely execution of project milestones">
- Manage risk assessments and mitigation strategies">
Requirements:
">Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree preferred)
">8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry
">Proven track record of leading projects through FDA submissions
">Strong knowledge of FDA regulations, aseptic processing, validation protocols, and good manufacturing practices (GMP)
">Experience with process validation, cleaning validation, and equipment qualification in aseptic manufacturing
">Benefits:
">A competitive salary and benefits package
">The opportunity to work on complex projects with a talented team
">Professional development opportunities
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