Manager Quality Assurance

Lets do this. Lets change the world. In this vital role you will responsible for overseeing and enhancing our DMS to ensure compliance with industry standards and continuous improvement of our processes. This role requires a strategic problem solver with a strong technical background and exceptional organizational and communication skills.

• Oversee a group of 5 to 10 staff ensuring their activities and priorities are managed in a compliant, structured manner.
• Ensures team are appropriately qualified and trained to carry out their DMS activities in a compliant manner per company procedures.
• Oversee and manage the budget associated with this staff including performing goal setting, performance reviews and compensation planning.
• Continuously improve documentation processes and practices to enhance efficiency and quality.
• Develop, implement, and maintain the DMS in accordance with industry standards and regulatory requirements.
• Conduct internal audits and coordinate external audits to ensure compliance with DMS standards.
• Analyze data and metrics to identify trends and areas for improvement in the DMS.
• Collaborate with various departments to resolve discrepancies and ensure consistent documentation practices.
• Provide training and support to staff on DMS processes and standard methodologies.
• Manage DMS-related projects, including setting goals, tracking progress, and ensuring timely completion.
• Stay current with industry trends and updates to DMS standards.
• Provide technical and organizational leadership toward resolving site and multi-site compliance issues.
• Provide support for domestic and foreign regulatory agency site inspections, as needed.
• Interact with other functional leads to ensure that operational standards, strategies, and direction meet organizational goals/objectives and are aligned with existing regulations and regulatory expectation.
• Monitor and bring up to senior management and management review established metrics representative of the health of the Document Management process.
• Support Continual Improvement initiatives, programs, and projects including owning and driving CAPAs, owning and revising documents.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 4 to 6 years of quality management systems or a related field experience OR
• Bachelors degree and 6 to 8 years of quality management systems or a related field experience OR
• Diploma and 10 to 12 years of quality management systems or a related field experience
• Certifications in quality management (e.g., ISO 9001, Six Sigma) are highly desirable.
• Proven experience in conducting audits and managing DMS-related projects.

Preferred Qualifications:

• Technical Proficiency: Strong knowledge of technical writing tools and software, including MS Word, MS Excel, SharePoint, and Veeva platform.
• Attention to Detail: Ability to meticulously review and edit documentation to ensure accuracy and consistency.
• Communication: Excellent verbal and written communication skills, with the ability to effectively collaborate with various departments and resolve discrepancies.
• Organizational Skills: Strong ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
• Adaptability: Ability to quickly grasp new concepts and react to changes in a rapidly evolving environment.
• Teamwork: Ability to work well with others and contribute to a positive team environment.
• Problem-Solving: Strong analytical skills to identify and resolve issues related to documentation.
• Customer Focus: Commitment to understanding and meeting the needs of internal and external key collaborators.