Regulatory Compliance Manager

Argenta

$90K — $120K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Minimum Bachelor's degree in a scientific or engineering field
  • Advanced degrees (MS, MBA, PhD) preferred
  • 10+ years of experience in Quality Management including team leadership
  • In-depth knowledge of FDA regulations and EU GMP guidelines
  • Strong understanding of cGMP requirements across various dosage forms
  • Experience with state licensing and DEA regulations
  • Proven track record in regulatory inspection management and compliance reporting

Responsibilities

  • Stay up-to-date with changes in pharmaceutical regulations
  • Develop and maintain compliance programs to meet legal standards
  • Act as liaison for regulatory agencies, managing inspections and submissions
  • Oversee licensing and registration with state and agency
  • Manage Supplier Management Program and Quality Assurance Program
  • Conduct audits and risk assessments to identify compliance gaps
  • Provide compliance training and maintain detailed documentation

Benefits

  • Strong company culture that values employee input
  • Opportunities for professional growth and development
  • Supportive team environment
  • Benefits aimed at maintaining employee well-being
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.

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