US WorldMeds · 19 hours ago
Manager, Quality Systems
Philadelphia, PA
Full-time
Onsite
Mid, Senior Level, Lead/Staff
$120K/yr - $137K/yr
8+ years expUS WorldMeds is a company focused on developing and maintaining quality systems in the pharmaceutical industry. The Manager, Quality Systems is responsible for overseeing quality management systems, ensuring compliance, and managing audits and regulatory inspections.
HealthcarePharmaceuticalHealth Care
Responsibilities
Serves as a leader for development, implementation, and continuous improvement of all quality systems
Responsible for maintaining document management systems for creation, approval, maintenance, issuance, control, and storage of GxP documents, which may include liaising with third parties to secure required documentation and /or store GxP documentation. Documents include, but are not limited to: technical transfer and validation documentation, batch records and batch release documents and data; stability protocols, data, and reports; and GxP documentation associated with quality systems; etc
Assists in establishing and delivering training programs and continuing education programs in the areas of quality assurance with emphasis on ensuring that the employee base has a clear understanding of regulatory quality system processes and tools including GxP requirements. Assist other departments in defining training requirements and liaise to ensure successful implementation
Responsible for coordination and preparation for Management Review Meetings. Responsible for collecting key quality and compliance metrics for presentation of monthly Quality updates and Management Review meetings Responsible for preparing minutes, action plans, etc. and following up to ensure resolution of issues. Responsible for setting up business tools and business processes to collect and capture Quality-related data to ensure reporting efficiency
Manages deviation, investigation, and product quality complaint programs
Manages the change control and corrective and preventive action processes including leading teams, monitoring system performance, and reporting on progress
Manages the Internal Audit program, including scheduling, conducting audits, supporting investigation of findings, and approving compiled responses
Supports investigation and documentation of all product quality complaints. Works with Medical Affairs team who manages the relationship with contract pharmacovigilance provider
Recommends change and process improvements to the organizational quality management systems to ensure sustained compliance and operational efficiencies
Responsible for coordination and preparation for Quality Review Board Meetings. Responsible for preparing documents for discussion, attending, preparing minutes, and follow-up
Serves as interface to third party organizations and regulatory agencies, particularly during third party audits
Responsible for supporting audits and regulatory inspections and being part of the team that responds to findings. Responsible for managing audit/regulatory inspections. Responsible for follow-up and communication on actions committed as a result of audit/regulatory inspection
Participates in educational programs related to pharmaceutical activities which have special emphasis in quality assurance and compliance with regulations and standards
Based on changing regulatory requirements, assist and facilitate revising, improving, and developing programs, policies, and procedures to ensure sustained compliance of the quality system
Manage internal and third-party investigation and deviation meetings. Communicate product quality issues to management and provide information when out of specification results, investigations, or other issues impact batch disposition or the status of marketed batches
Qualification
Required
Bachelor's Degree
Minimum eight years experience in the pharmaceutical, medical device, vaccines, blood, or biologics industry
Minimum 5 years experience in quality assurance with quality systems responsibilities
Preferred
Supervisory Experience
Company
US WorldMeds
US WorldMeds is a closely-held, Kentucky-based specialty pharmaceutical company. Our mission is to develop, license and commercialize
51-200 employees
H1B Sponsorship
US WorldMeds has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2020 (6)
Funding
Current Stage
Growth StageTotal Funding
$15MKey Investors
National Institute on Drug Abuse (NIDA)
2016-07-01Series Unknown
2013-06-18Grant· $15M
2006-11-13Seed
Leadership Team
H Lee Warren
Chief Operating Officer
Recent News
2025-11-04
Genetic Engineering News
2025-10-28
Company data provided by crunchbase