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Careers - Director, Quality and Regulatory Compliance
Since 1938, new parents in Finland have been sent home from the hospital with one unique, yet simple gift: A cardboard box. Filled with newborn essentials, the boxes are also designed to be a baby’s first bed. Combined with pre-natal and post-natal care and education, the boxes are credited with drastically reducing infant mortality. The Baby Box Co. is an innovative educational program equipping parents with resources to give their babies a safe start in life.
- The baby box was invented in Finland which has one of the lowest infant mortality rates in the world.
- Starting as an e-commerce business, The Baby Box Co. has evolved to wholesale and are now reimagining themselves as a free online education platform for parents, Baby Box University.
- Baby Box Co. has garnered serious attention by distributing FREE baby boxes with safe and useful products to parents in certain markets, a program that will continue to expand.
THE OPPORTUNITY: DIRECTOR, QUALITY AND REGULATORY COMPLIANCE
Provides leadership and direction for product quality, regulatory affairs and compliance across The Baby Box business operations. The primary responsibilities include ensuring adherence of all applicable regulations and procedures in the manufacturing process (cGMP, ISO, FDA, FTC, etc.), create and maintain master MFG records and batch records, create and maintain SOP’s, assist in training, lead all audits, assist in the research and development of new products and the continuous improvement of current products. The department is responsible for the company’s regulatory compliance of manufacturing products for the consumer’s use. Directs the development, communication and implementation of policies, procedures, systems enhancements, budget, capital expenditures and projects.
- Directs the activities as assigned for regulatory affairs and compliance throughout the business.
- Ensuring a products quality during the production process and applicable regulations and procedures are adhered to (cGMP, ISO, FDA, FTC, etc.)
- Serves as the company's most responsible contact for any necessary interactions with regulatory authorities. Interact with domestic and foreign regulatory authorities in the same capacity as necessary. Interact with regulatory agencies to answer questions, plan meetings, obtain information, and otherwise facilitate regulatory interactions.
- The production and supply chain department is one of the most crucial areas in a company since the products name is at stake. It is the sole responsibility to ensure that every product manufactured undergoes the quality and standards of the company.
- Create and maintain SOP’s, assist in training, lead all audits, assist in the research and development of new products and the continuous improvement of current products.
- Be proactive to minimize or eliminate regulatory issues to help prevent any impact of adverse regulatory activities on the corporate reputation, market or bottom line.
- Lead all audits required from regulatory agencies, customers and prospects.
- Co-ordination with various stake holders, project teams, strategic sourcing, QA/QC, systems, supply chain, sales, equipment, facilities, project management to plan scale up activities in effective & timely manner.
- Implements decisions necessary to accomplish functions of position or to execute responsibilities.
- Investigates, reviews, and recommends new procedures, policies and/or technology that would improve or enhance the department’s capability to deliver service, quality, compliance and build sales.
- Communicates delivery of service, processes or product issues that affect Company’s market position or reputation to other Company management as appropriate.
- Participates in effective management sessions and contributes to discussions regarding Company quality, compliance, improved manufacturing, distribution operations, packaging, materials management, and product life cycle management.
- Strong written and verbal communication skills and organization skills. Experience in international, federal, state and local regulatory compliance, manufacturing, QA/QC, ISO, manufacturing equipment, distribution, packaging, procurement and project management.
- Experience & understanding of various process technologies, manufacturing, supply chain and consumer goods industry.
- Knowledge as well as application & data interpretation skills with respect to QA/QC, regulatory compliance, lab / testing operations, testing guidelines and processes, stability study, related substances, etc.
- Minimum 10 years relative and similar experience in a fast pace, high growth, multiple facility manufacturing, laboratory, packaging and distribution environment.
- Creative problem solving skills, analytical skills and strong attention to detail and follow through.
- Ability to work independently, leading projects from start to finish with minimal over sight.
- Experience leading multifunctional teams, regulatory authorities and working with outside clients.
- Advanced degree required.
To apply, please contact us at email@example.com