Site Quality Manager - Life Sciences Manufacturing

One of our Life Science Manufacturing clients is seeking a Site Quality Manager to join their growing team in King of Prussia, PA. This is a full-time and permanent opportunity. This is a great opportunity to join and advance with an innovative and high-growth global company committed to sustainability. The Site Quality Manager will oversee the quality control and quality system functions, ensuring compliance with global pharmaceutical regulations and standards, company quality policies, and industrial standards such as ISO 9001. This individual is responsible for all quality control laboratory supervisors, leads and technicians, and will be working cross-functionally with Global Teams and Site Leaders, acting as a bridge between Quality and Production. Other responsibilities include:Accountable for all incoming, in-progress and final product testing and supervises lab instrumentation and calibration schedulesMonitor and communicate non-conformances and recommend measures to improve methods and quality of productDevelop and implement changes in working conditions and use of equipment to increase efficiency of the department and quality mattersCommunicate all deviations and non-conformances to plant management, support investigations and work closely with global quality teamsOversee internal audit process and coordinate with authorities and customers for the planning and execution of audits.Develop and maintain site quality metrics and ensures compliance and identification of trends leading to site/process/product improvements.Oversee the process for reviews of completed batch production and laboratory control records of critical process steps before release of the products for distributionAnalyze and approve general and operating procedures, work instructions and other quality-related documentsEnsure a robust stability program supporting product, raw materials, QC Reagents and sets retest/expiry dates and storage conditions where appropriateQualifications:Minimum of a Bachelor's Degree in a related field7+ years of Pharmaceutical Quality Assurance and Quality Control experienceMinimum of 3 years of Supervisory or Management experiencePrior cGMP experienceKnowledge of 21 CFR Parts 210/211, ISO 9001 standard requirementsSalary: $115,000-$150,000 (flexible based on experience)Hours: Monday-Friday, 8:00am-5:00pmHiring MethodFull-time permanent opportunityBenefits: We offer benefits to support our associates' health and wellness, such as healthcare and time-away policies. We also offer benefits designed to promote our associates' financial well-being, including short- and long-term financial incentives and retirement income and planning.Exact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Created: 2025-01-14