Regulatory Compliance Manager

Argenta•Shawnee, KS

23h•Onsite

About The Position

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.

Requirements

Minimum Bachelor’s degree in scientific field or engineering field.
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

Nice To Haves

MS, MBA, or PhD preferred.

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.