Full Job Description
Argenta is currently looking to fill the role of Regulatory Compliance Manager at our Shawnee, KS location. This position plays a critical role in maintaining and advancing the quality and compliance framework across the site. This role will provide guidance and oversight on all compliance-related matters in accordance with applicable regulatory requirements, cGMP standards, and Argenta's quality policies.
The role is responsible for driving a culture of compliance and continuous improvement, ensuring that all site activities meet the
highest standards of regulatory and quality performance. The Compliance Manager partners closely with cross-functional teams
including Quality Assurance, Operations, Regulatory Affairs, and Client Services to ensure robust systems are in place and
functioning effectively.
Key Responsibilities:
• Stay current on changes in domestic and international pharmaceutical regulations.
• Develop, implement, and maintain compliance programs to meet all applicable laws and standards
• Serve as the primary point of contact for regulatory agencies, coordinating inspections, submissions, and responses
• Oversee state and agency licensing / registrations
• Oversee Supplier Management Program
• Oversee QAA program
• Conduct audits and risk assessments to identify compliance gaps
• Provide training to employees on compliance and quality
• Maintain detailed records and documentation to demonstrate compliance efforts
• Report non-compliance issues to senior management and recommend corrective actions.
About You:
• Minimum Batchelor's degree in scientific field or engineering field.
• MS, MBA, or PhD preferred.
• 10+ years in Quality Experience including management of people.
• In-depth knowledge of FDA regulations, EU GMP, and ICH guidelines
• Strong understanding of cGMP requirements across dosage forms
• Experience with state licensing
• Experience with DEA
• Proven experience in regulatory inspection management and client-facing compliance reporting
• Ability to interpret regulatory requirements and translate into practical site-level compliance actions
Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued. At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through a strong culture, great benefits, and growth opportunities.