Quality System Manager

Job Title: Senior Manager, Quality Systems & Compliance

Location: Columbus, Ohio area (can be remote)

Salary Range: Starting at $115,000 (flexible based on experience and qualifications)

Position requires 50% travel domestically within the U.S.

Kelly 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. You will play a critical role in maintaining product standards, supporting audits, and driving continuous improvement in their regulatory processes.

• 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.

• 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.

If you meet the above qualifications, apply now to join our customer’s team as a Quality and Regulatory Manager and help ensure their products meet the highest standards of compliance and quality.