Compliance Manager manages the compliance programs, policies, reporting, and practices for an organization or business. Ensures that all activities follow regulatory requirements related to the governance of the organization as well as any industry-specific or location-specific laws. Being a Compliance Manager oversees internal controls and auditing systems that monitor and report on regulated activities and processes. Implements risk-based compliance testing of existing procedures and controls to identify, detect, and correct noncompliance. Additionally, Compliance Manager evaluates and implements changes to compliance processes due to new or amended regulations. Delivers communication and training initiatives that inform stakeholders about compliance requirements. Requires a bachelor's degree or equivalent. Typically reports to a director. The Compliance Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Compliance Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Essential Tasks and Responsibilities:
· Review raw material documentation and make disposition decisions
· Assist with training and oversee risk management activities ISO 14971, HACCP, etc.
· Assist with development and review of documents related to regulatory compliance
· Oversee quality auditing (including supplier quality) and assist with review and approval of Batch Production Records and NCMR investigations.
· Support regulatory and customer audits.
· Manage corrective actions as assigned from audits.
· Support and coordinate efforts and priorities with other departments to ensure timely release of the raw material, packaging components and finished products.
· Oversee creation and approval of necessary documentation for out-of-house processing.
· Complaint management including internal investigations.
· Continuous Improvement.
· Review product labels for content, appearance and regulatory compliance.
· Other responsibilities as assigned.
Education & Experience Requirements
· Scientific degree or equivalent strong analytical experience
· Knowledge and experience in good documentation practices
· Understanding of cGMP 21 CFR 111 and other regulatory requirements pertinent to dietary supplements, or pharmaceutical manufacturing and laboratory testing
· Strong preference to experience in TGA or MHRA
Competencies & Qualifications
· Attention to detail and accuracy
· Excellent interpersonal and listening skills
· Strong verbal and written communication skill
· Data analysis and problem solving
· Adaptability and initiative
· English proficiency required
Physical Requirements:
· Employee must exert up to 20 lbs. of force occasionally, and/or up to 10 lbs. of force frequently, and/or a negligible amount of force constantly to move objects
· Specific vision abilities required by this job include close vision, distant vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
· May be exposed to a dusty environment and/or considerable noise
Job Type: Full-time
Benefits:
Schedule:
Ability to Relocate:
Work Location: In person
0 Compliance Manager jobs found in Ogden, UT area