Genexa LLC
Regulatory Compliance Manager
Genexa LLC, Atlanta, Georgia, United States, 30383
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
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