Our client is a growing biosciences company that manufactures and markets science-based, top-quality pure supplements, supplement blends, and nootropics to support the body and mind
Since its inception in early 2010, the company has earned the trust of a growing set of “in the know” customers through product innovation, uncompromising quality, and exceptional customer service. In more recent years, the management broadened the company’s scope and the range of products to reach a wider addressable market in the self-care and wellness space. Their brand recently introduced new products in various formats (pure powders and stacks, formatted as bulk powders, capsules, liquid blends, and future gummy production) and transformed its website to reach this broader target audience.
Also, to accommodate its growth plans, the company purchased and relocated to a new manufacturing facility located in a pleasant corporate park environment in Illinois.
Their mission is to improve the quality of your life.
They believe wellness shouldn’t be reserved for the wealthy or those with specialist knowledge. They believe that everyone has the right to feel their best, and it’s their mission to make it easy.
Their Values are simple: Customer Focus, Teamwork, Pushing the Boundaries.
They differentiate themselves with New Product Innovation, Exceptional Customer Service, and by never compromising on Quality.
The company is currently seeking an R&D and QA Manager.
Reporting directly to the Founder & the Chief Science Officer, the R&D & QA Manager will lead all aspects of product development from concept to commercialization as well as be responsible for building and managing the Quality Management System. Reporting to the position are one PhD product Developer and 3 QA technicians.
Who You Are And What You’ll Do
The QA and R&D Manager will manage all aspects of the New Product Development & Quality Assurance Program. This individual will be responsible for building and managing the Quality Management System and developing the team’s in-depth knowledge of the regulatory requirements established by FDA GMP as applicable to dietary supplements. As our client is a small company, this individual will be expected to spend time on the production line to troubleshoot quality issues or attend to start-up for new product trials, etc. The individual must have excellent leadership, communication, and interpersonal skills to work within a fast-paced team environment that requires the ability to handle multiple demands. The incumbent will work very closely with both the CSO (Chief Science Officer) and CMO (Chief Marketing Officer) with a strong emphasis on technical documentation, communication, and coordination to roll out new products. The incumbent will also work closely with the COO and Operations to ensure compliance with all applicable elements of the FDA GMP regulations and product specifications.
- Map out a technical development plan and supervise the formulation and development process for new products.
- Review and approve all Product specifications, Process CCPs, and Product Labels.
- Support management of existing and new materials suppliers through activities that assure quality/identity and purity, as well as compliance with applicable regulatory requirements.
- Facilitate the establishment and maintenance of a suitable document management system for compliance with FDA GMP requirements.
- Provide periodic regulatory training.
- Lead internal audits and subsequent programs to ensure GMP compliance and procedures are followed throughout the site.
- Represent the Company during FDA inspections.
- Direct and facilitate investigations for deviations as needed, and lead CAPA.
- Establish appropriate quality metrics consistent with business objectives, and periodically report progress.
- Review and approve or reject all finished goods, procedures, specifications, materials, and protocols.
What You’ll Need To Succeed
This is a hands-on position in a dynamic environment, which is still building critical capabilities while developing platform innovation. A strong technical background as well as leadership and versatility are critical for success:
- A Ph.D., M.S., or B.S. in Chemistry, Biology, Engineering, or related field.
- A working knowledge of new product development and processing in food, pharma, or related segment in CPG industry.
- 5+ years of leadership experience in Regulatory Affairs, Pharmaceutical Quality Management, or related field.
- Strong working knowledge of FDA CGMP and guidelines.
- Excellent communication and interpersonal skills to work within a diverse and rapidly changing work environment, communicating with senior managers and colleagues to ensure effective implementation and compliance of the quality program.
- A proven track record of establishing, implementing, leading, and managing a CGMP-compliant quality program is essential.
Our client offers competitive compensation and benefits including medical, dental, vision, life insurance, vacation, 401(k), and paid holidays.
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Our client is committed to diversity and inclusion to drive business results and create a better future every day for their diverse employees, global consumers, partners, and communities. They believe a diverse workforce allows them to match their growth ambitions and drive inclusion across the business. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Employment is subject to verification of pre-screening tests, which may include background check, credit check, and DMV check.
All Candidates must be able to work in the U.S. without sponsorship.