Regulatory Compliance Manager

WHO WE ARE

Genexa is a fast growing, early-stage company founded by two dads on a mission to revolutionize OTC medicine. We are disrupting the $100 billion+ OTC drug industry by offering a broad line of health products. Genexa uses the same active ingredients, as other leading brands for effective symptoms relief, but our products are free from of all chemical inactive ingredients. We call it real medicine made clean and we are in a category of one. We are an Atlanta-based company with a B-Corp Certification.

ABOUT THE ROLE

Genexa is seeking a meticulous and energetic Regulatory Compliance Manager to join our dynamic, innovative team at our Atlanta, GA headquarters. The RC Manager position is a strategic role which will oversee all compliance activities related to our business and products, in both the US as well as internationally. We're all about winning. We work hard as individuals, celebrate our successes as a team, and have a lot of fun along the way. It's a fast-paced and collaborative environment where coaching, developing, and growing together is a true priority.

Key Job Responsibilities Include:

• Manage the customer complaint process, including review of CMO investigations and timely closure of customer complaints, as well as perform complaint trend analysis.

• Manage the internal audit program

• Manage the Supplier Qualification and Training programs

• Oversee the timely closure Corrective and Preventive Actions (CAPAs) and Deviations initiated

• Complete, review and/or approve assigned deviations

• Oversee the change control process to ensure timely closure

• Coordinate and review changes to product labeling

• Coordinate and facilitate Management Review Meetings

• Manage Genexa certifications

• Work directly with the Head of Quality in regulatory inspection readiness activites

• Review/revise Standard Operating Procedures (SOPs) to further develop the Quality Management System (QMS)

• Lead and participate in cross-functional teams to drive improvements in processes that impacts compliance

• Identify and implement projects for the continuous enhancement of the Quality Management System

• Perform other duties as assigned

WHAT YOU SHOULD HAVE

• Bachelor's degree in a Chemistry or other related science field

• Minimum 5 years of experience in Quality, preferably in the CPG industry.

• Experience working with GMP regulations

• Strong attention to detail

• Strong documentation skills

Current Openings for Regulatory Compliance Manager Jobs at Genexa