Capsugel is currently seeking a R&D Quality Assurance Manager for our rapidly growing site in Bend, OR. We are looking for someone with an entrepreneurial spirit, who brings not only their knowledge and expertise in quality systems, but can identify resources for new technology.
The R&D Quality Assurance Manager is responsible for ensuring procedures, systems, and processes effectively meet R&D Quality requirements and business needs.
The successful candidate will be a seasoned professional with experience in R&D pharma or related FDA regulated industry.
Responsibilities include but are not limited to:
Manage and oversee assigned aspects of the R&D Quality Assurance
Build and establish a team of QA professionals for lifecycle management of R&D quality documents
Responsible for architecture and design of quality systems that ensure compliance with Good Manufacturing Practice (GMP)
Improve quality management systems related to the product lifecycle from development to commercialization, overseeing activities related to R&D and technology transfer
Continuously identify more effective ways to drive performance
Partner with colleagues across functions to build trust, inspire others and drive results
Support internal audits, client audits
Keep current of applicable regulations, guidance and standards
Bachelor’s Degree at minimum
Experience in pharmaceutical or related industry
Experience in Quality Assurance management preferred
Must have a Phase appropriate approach to quality systems
Minimum 1 year of GMP experience
Must possess excellent verbal and written communication skills, with the ability to communicate effectively with internal and external customers
Capsugel provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Capsugel complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Capsugel expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Capsugel’s employees to perform their job duties may result in discipline up to and including discharge.
Capsugel Bend (formerly Bend Research) is the leader in drug delivery technologies and formulation development. What sets Capsugel Bend apart is a depth of knowledge and experience in fundamental science and engineering. We’re known for enhancing the bioavailability of low-solubility compounds, but offer much more.We focus on developing a deep scientific understanding of our clients’ most challeng...ing drug development problems, and applying novel solutions to advance difficult compounds to market.