Company Summary:
A well-established Biotechnology firm is currently seeking a driven and organized Quality Specialist with a strong background in Quality Management Systems and pharmaceutical development. You will play a key role in their quality management, drug safety and compliance. In addition to that, you will be collaborating closely with key business stakeholders, identifying needs for process standardization and regulatory compliance. Are you interested in taking your next step in the pharmaceutical development industry? If so, please reach out to learn more.
Responsibilities:
* Help establish of GxP Policies, SOP and Supporting Documents throughout development of organizational enterprises and ensure a consistent GxP process landscape for standards and processes and procedures related to clinical development and safety/pharmacovigilance.
* Develop strong relationships with key stakeholders, ensuring that PDQ is providing an efficient, effective and compliant process landscape to the functions.
* In close collaboration with supported functional areas and key business stakeholders, identifies needs for process standardization, regulatory compliance direction and areas for improvement.
* Ensures that business partner expectations for SOP strategy, materials and deployment are met and up to date
* Supports internal process improvement projects.
Skills:
* Experience developing multiple procedural documents simultaneously with In-depth knowledge of pharmaceutical development processes, including Quality Management Systems, and GxP regulations.
* Skills for problem identification / resolution in a complex environment or potential conflict.
* Ability to build and maintain strong relationships within PDQS and with key partners.
* Ability to assimilate new and emerging compliance information or trends.
* Strong verbal and written communication skills (including presentations) and ability to influence and lead without authority.
* Ability to work effectively in an international multicultural matrix organization.
* Fluency in written and spoken English.
* Computer proficiency, including Microsoft applications, Adobe Acrobat, and Documentum (or similar).
* Demonstrated ability to effectively organize and execute tasks and operation with personal leadership.
