The Director of Quality Assurance and Regulatory Affairs has overall responsibility for the department and management of Adventure Ready Brand's Quality System and Regulatory requirements of all new, altered or exiting products across all divisions.
ESSENTIAL JOB FUNCTIONS
Ensure the compliance of Adventure Ready Brand's manufacturing and testing activities with respect to Adventure Ready Brand's procedures as well as FDA, EU, ICH, Health Canada, and other regulatory requirements for both drug and medical device products.
Developing and implementing improvements to the Quality Management System.
Perform internal audits of Adventure Ready Brand's operations and perform external audits of suppliers, contract service providers, and contract testing laboratories.
Monitor and maintain reports and databases for change control, customer complaints, deviations, CAPA, and out of specification tracking.
Release of intermediate and finished product upon review of batch documentation and testing results.
Perform Annual Product Reviews for each of Adventure Ready Brand's OTC drug products.
Oversee and perform product and process validations for OTC drug products.
Oversee and facilitate cGMP training for all of Adventure Ready Brand's employees.
Provide direction on branding to assure all FDA (OTC drug / Medical Device) and EPA product meet regulatory requirements.
Provide direction on branding to assure all products marketed in Canada meet Health Canada regulations (TPD, NHPD, PMRA, etc.)
Maintain Trademark registrations, state registrations, California taxation requirements.
Monitor competitive products and suppliers to regulatory conformance including FDA recalls and warning letters.
Development of Quality / Regulatory department staff.
Development and monitoring of QA/QC/RA budget.
Other duties as assigned.
Bachelor of Science degree in a life science field.
Team player able to effectively interact and work with various functional departments.
Have exceptional communication skills.
Flexibility and ability to adapt to change and to operate effectively in ambiguous situations is required.
Excellent interpersonal and leadership skills.
Able to lead a team successfully in a fast-paced environment and able to prioritize daily demands to meet tight deadlines.
Have a history of exceeding expectations.
Be very detail oriented.
Possess a can do attitude and passion for business.
In-depth knowledge of manufacturing requirements detailed in FDA and EU guidelines for both drug and medical device products.
National and International Regulatory knowledge
3-5 years experience in top-level management of a quality system meeting the requirements of 21 CFR 210, 211, and 820.
Internal Number: 13295
About Adventure Ready Brands
About Adventure Ready Brands
Adventure Ready Brands headquarters is located in the heart of the White Mountains in Littleton, New Hampshire. The company was founded in 1973, incorporated in 1977, and manufactures the world-famous insect bite treatment, After Bite®, a full line of well-known insect repellents such as Ben's® and Natrapel®, first-aid such as Adventure Medical Kits® and Easy Care First Aid™ kits, survival products with Survive Outdoors Longer®, and burn remedy products such as AfterBurn®. Many of our products are packaged in innovative ways that allow them to be convenient to use as well as environmentally friendly.
Here at Adventure Ready Brands, we pride ourselves on producing products of the highest quality, providing the best sales and service for our customers while creating value for our employees and our community. We see our employees as our greatest asset and strive to build a strong united team in order to accomplish our goals and achieve our vision: to enjoy the outdoors in every condition. We place a strong emphasis on work ethic, quality assurance, and efficiency which we feel are important in creating a successful business and work environment.
Ada...ptability and change are two concepts that Adventure Ready Brands also strongly embraces. We feel that being nimble and flexible is important to our business and our working environment. We are made up of many different cultures, backgrounds, and styles which when combined have proven our success. To this end, Adventure Ready Brands will also strive to adapt and improve as the need arises in order to continue our growth and success for the benefit of our customers, our employees, and our community.
County & Municipal Supply Program to fight ZIKA Virus
Environmental Studies Scholarship Fund