Regulatory Compliance Manager

Regulatory Compliance Manager Argenta - 3.4 Shawnee, KS Job Details Full-time 20 hours ago Qualifications Bachelor's degree Team management Quality assurance experience within pharmaceutical industry Full Job Description At Argenta, we're more than a company — we're a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it. Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market. We're in a unique position. We are the world's only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health.

Our uniqueness means:

We are ambitious, growing and building a 'one team' culture, guided by our values. We are team players; We are doers; We are customer-centric; We are innovators . We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best "paw" forward we will make the lives of the animals we care for, better. With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let's Make It Happen, Together.

TEAM PLAYERS

who want to DO great work and find

INNOVATIVE

ways to make animals lives better through our

CUSTOMER CENTRIC

efforts should apply. 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. Argenta is an equal-opportunity employer To find out more about Argenta, click here: www.argentaglobal.com