At Dohmen Life Science Services, we are committed to keeping our clients for life, ensuring no conflict of interest exists, achieving continuous innovation, and focusing on continuous improvement. Our behavior is guided by five simple values that define how we work and are the essence of what makes us successful:
Caring: We are empathetic and respectful. We ask “How can I help you?”
Committed: We are dedicated and persistent. We ask “How can I make it happen?”
Creative: We are inventive and imaginative. We ask “How can I do it better?”
Collaborative: We are cooperative and share our knowledge. We ask “How can we achieve success?”
Courageous: We’re willing to risk failure over inaction. We ask “How can I challenge myself?”
The purpose of this position is to develop, implement and maintain the Quality Management System (QMS) to comply with regulations governing Good Distribution Practices (GDP). The most important aspect of this position is to take full responsibility for assuring compliance to all applicable federal (FDA, GDP, DEA, GXP), state licensing, local, ICH, International (where applicable) regulations/standards and client requirements. This position provides tools required to manage, monitor and improve the quality and compliance aspects with the DLSS-three sites in Memphis, TN and Fontana, CA locations. Execution of these activities helps to assure compliance to client and regulatory requirements, and provide tools to foster Performance & Quality Improvement (PQI) efforts.
The position is also responsible for researching, recommending, and implementing best practices, and contributes to both the strategic and the operational aspects of complying with the GDP regulations. This position is responsible for advising and consulting with all stakeholders about compliance with applicable regulations.
Our people leaders are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
People leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values. In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities:
Essential duties and responsibilities:
Strategic Regulatory and Quality planning/execution of Quality and Regulatory plans and Programs.
The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.