Atrium Innovations is a recognized innovative leader in the development, manufacturing, and commercialization of science-based nutritional and supplement health products. The company’s mission is to be a global leader in vitamins, minerals and supplements, offering free form science based nutritional solutions. Its brands and business model are complementary with Nestlé Health Science, its parent company, offering science-based nutritional solutions for consumers, patients, doctors, nurses and other partners in healthcare. Atrium Innovations brands include Pure Encapsulations®, Douglas Laboratories®, Genestra BrandsTM, KLEAN Athlete®, Garden of Life®, Orthica®, PharmaxTM, TrophicTM, Minami Nutrition®, AOV®, and Wobenzym®.
Position Summary: This role develops and deploys the quality strategic plan to strengthen the organization’s quality leadership position in the industry and prepares the organization to meet the challenge of continued growth. Responsible for providing leadership and direction for quality assurance inclusive of laboratory operations, quality assurance, and product assurance across the site.
As an active member of the factory leadership team, the responsibility of the Associate Director of Quality Assurance includes, but is not limited to, implementing and managing an effective quality system at the Pittsburgh site that is aligned globally to assure the highest quality of products manufactured, sourced and distributed. Define continuous improvements to operations processes and quality systems resulting from review of quality trends and metrics. Develop a foundation of highly capable, aligned and engaged quality team members. Escalate risks in a timely and effective manner. Implement a robust GMP program, an independent audit program to ensure risks are identified and addressed to maintain Atrium brand reputation. Provide regulatory Compliance (GMP) oversight of all GMP activities within each of the sites. Ensure regulatory compliance and quality metrics are met; lead the development and implementation of actions to close metric gaps. Direct the development, communication and implementation of quality policies, procedures, system(s) enhancements, budget, capital expenditures and projects.
Successfully manage initiatives to achieve financial efficiencies, growth, operational efficiency, and quality. Coordinate and maintain effective relationships with internal and external stakeholders. Collaborate with supply chain and other cross functional partners end to end to enable reliable product supply. Partner with supply chain to ensure appropriate product supply metrics and targets are established, monitored, and met. Create a culture of quality, helping all cross functional partners in the commercial organization understand how they impact product quality, safety, and regulatory compliance.
Key Responsibilities: • Directs the activities as assigned for laboratory operations, quality control and assurance, product assurance, and quality systems for Site operations • Clearly communicate quality assurance results, opportunities, project status, corrective actions to the management team and other stakeholders • Lead quality assurance to actively participate in key activities related to the product realization from development through to launch and commercialization • Work across multiple cross functional teams to develop aligned strategies covering key functional requirements • Connects all necessary functional inputs, aligning all teams, and escalating issues for resolution • Ensure complaints are well managed, issues are understood, and trends in complaints/adverse events are understood and addressed as necessary • Act as an expert consultant/mentor to team/staff and other functional groups on quality and technical issues/matters • Lead, develop and implement processes to ensure compliance with global requirements for assigned products • Provide necessary interactions with regulatory authorities, audits, customers, and prospects Interact with regulatory agencies to answer questions, plan meetings, obtain information, and otherwise facilitate regulatory interactions. Lead all audits required from regulatory agencies, customers, and prospects • Manage cost efficiency, quality assurance initiatives, budget, capital planning, performance reports, and project management and key performance measurements • Roll up site level Quality Management Reviews to initiate and ensure continuous effort on quality system improvement and provide feedback for on-going improvements.
Experience and Education Requirements: • Bachelor’s degree in a science related field with 10 + years of Quality Assurance experience in a pharmaceutical, nutraceutical, consumer goods, or federally regulated manufacturing organization in a fast pace, high growth, multiple facility manufacturing environment • In-depth knowledge in standards, policies and procedures including FDA and international GMP. Ensure product quality during the production process and adherence to applicable regulations and procedures i.e. cGMP, ISO, FDA, etc. • Experience in continuous improvement methodology, to include Nestle Continuous Excellence, TPM, LEAN are preferred • Demonstrated track record and experience leading professionals in a matrixed environment • Demonstrated experience leading professionals in a matrixed environment is required • Experience in multiple delivery forms i.e. tablets, caplets, capsules, soft gels, powder, and pellets. The experience of other dosage forms like liquids, topical, sterile dosage form will be added advantage • Excellent leadership and communication skills, with an open, collaborative, interactive leadership style • Demonstrated strategic thinking capabilities, ability to help define a vision for the future • Ability to translate strategy to execution and drive the organization forward in executing and delivering results • Sound business skills, including financial acumen and business planning • Excellent collaborative leadership style and coaching skills with ability to build and nurture strong, positive relationships with business leadership and cross functional partners • In-depth experience in dealing with regulatory inspections and inspectional requirements • Direct working knowledge of the business environment outside of the quality organization (e.g., manufacturing, product/process development, customer service, etc.) is desired • Working knowledge of the business environment inside a quality organization, across various roles (e.g., quality operations, QC, Quality Systems, pre-production quality assurance, validation, regulatory, etc.) • Demonstrated knowledge of applicable regulations within the US (FDA) and outside the US (e.g., Health Canada) • Knowledge as well as application & data interpretation skills with respect to QA/QC, regulatory compliance, lab operations, testing guidelines and processes, stability study, related substances, etc.
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