Kelly Science, Engineering, Technology & Telecom ยท 10 hours ago
Quality System Manager
Columbus, Ohio Metropolitan Area
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
8+ years expKelly Science & Clinical is seeking a highly motivated Senior Manager of Quality Systems & Compliance for a health and wellness company to lead their regulatory compliance efforts across all operations. In this pivotal role, you will oversee and ensure adherence to all applicable regulations, working closely with contract manufacturers and vendors.
Staffing & Recruiting
Hiring Manager
Juanita Drummond
Responsibilities
Lead and manage the regulatory compliance strategies for the organization, ensuring products meet all federal, state, and industry-specific standards
Serve as the primary point of contact for regulatory agencies and oversee all communication and reporting requirements
Collaborate with contract manufacturers and vendors to conduct regular audits, ensuring adherence to regulatory standards
Develop, implement, and maintain documentation and procedures to support compliance efforts
Review and approve product labeling, packaging, and marketing materials in compliance with regulatory requirements
Train and mentor staff and direct reports (3) to uphold regulatory standards
Stay current with evolving regulations and industry best practices, proactively adjusting internal processes accordingly
Facilitate internal and external audits, preparing necessary documentation and addressing any findings or corrective actions
Qualification
Required
BS/MS degree in Regulatory Affairs, Quality Assurance, Life Sciences, or a related field
8+ years of hands on and management experience within a manufacturing, distribution, or related environment
Strong knowledge of FDA, OSHA, and other pertinent regulatory frameworks
Demonstrated ability to manage audit processes and work effectively with third-party vendors and contract manufacturers
Excellent leadership, communication, and organizational skills
Ability to travel approximately 50% domestically within the United States to collaborate with vendors and conduct audits
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
Company data provided by crunchbase