The Senior Manager of Site Quality Operations is responsible for developing and executing the site quality strategy in partnership with the site General Manager, which will enable the firm to continue to be an industry leader in production and quality operations. The role is responsible for all elements of the site quality strategy including managing tactical quality teams, monitoring, and releasing materials/product and hosting regulatory inspections and customer visits. The primary responsibility of this role is the overall compliance of the site to customer and regulatory agency requirements. The successful candidate will have a strong history of compliance system management at a manufacturing location in at least one of the following regulated industries; cosmetic, pharmaceutical, or medical device. The candidate will have a strong track record of people leadership and excellent communication skills, and the ability to organize, inspire, and lead a diverse group of employees. This candidate will be able to partner with internal functional groups and with external customers ensuring the protection of proprietary information for customers and Voyant Beauty. The Senior Manager of Site Quality Operations has oversight and manages the entire site Quality Department. This role assures that the quality & regulatory affairs systems are managed, continuously reviewed, and improved for compliance and operating efficiencies. This individual will ensure that the Quality department personnel are trained. In addition, the Senior Manager of Site Quality Operations will ensure compliance for multiple regulated product categories; aerosol, pharmaceutical/OTC, cosmetic, personal care, medical device, household (EPA regulated), and ISO standards. Role & Responsibilities * Ensure compliance with all applicable Customer, ISO, and regulatory agencies (e.g. FDA, Health Canada, EMA, etc.). * Direct the site on quality compliance standards and expectations. * Manage the Batch Release Process: completes quality assurance operational requirements by scheduling and assigning employees and providing adequate oversight to ensure that requirements are met. * Manage the site's nonconformance, investigation, and CAPA program. * Manage the site's external (customer) specification documentation process including the Fill & Assembly Specification process. * Manage the site's Customer Complaint and Internal Audit program. * Manage the site's Analytical and Microbiological laboratories and their associated testing. * Manage the site's In-Process and Incoming Inspection processes. * Review, comply with, and manage customer quality agreements. * Act as liaison with site customers on commercial quality topics and quality issues. * Host and support all Quality System audits and inspections as the Generalist (Lead Quality SME). * Report KPIs and site quality metrics to Operations, Corporate Quality, and Executive Leadership. * Monitor compliance to the training program and ensure training records are adequately maintained and easily retrievable. * Author, review, and approve site level documents and records as required. * Manage the Document Control and retention programs. * Ensure continuous improvement in the quality system. Qualifications and Education Requirements * Bachelor's Degree required in the sciences, engineering, or related field of study. Master's Degree preferred. * Certified Quality Auditor/Manager/Engineer, etc. preferred. * 10+ years' in quality assurance and/or regulatory leadership. * Expert knowledge of regulations for Pharmaceutical/OTC, Cosmetic, and Medical Device manufacturing (e.g. cGMP, USP, 21 CFR 820, 210/211, GLP). * Familiar with aerosol product manufacturing preferred. * Progressive leadership roles within quality organizations with proven successful track record (with multi-shift direct reports preferred.) * Strong leadership and communication skills with demonstrated team building success. * Mentors as needed in and supports development opportunities for direct reports * Creative conceptual thinker with strong analytical and problem-solving skills; comfortable with technical issues. Other details * Job Family Manager * Pay Type Salary Apply Now * Elkhart, IN, USA