At DiaMedica Therapeutics, we seek talented contributors who thrive in a high-energy team environment and want to make a real and lasting impact in the field of therapeutics. DiaMedica Therapeutics teams are creative, collaborative, open, committed–and central to the success of this company and its mission. If this is the kind of company you want to work for, we want to hear from you.
Please, no unsolicited resumes from recruiters.
DiaMedica Therapeutics Inc. is seeking a Quality Systems Specialist responsible for implementing and supporting the development and maintenance of a robust quality system in compliance with all relevant standards and regulations. Create, deploy and improve quality system processes in support of corporate objectives. Directly involved in shaping strategies that will support on-going improvement and effectiveness of the quality system. Responsibilities include the areas of clinical research (GCP), non-clinical research, manufacturing (GMP), laboratory testing (GLP), and Quality Management System (QMS) development to meet business objectives.
Primary Job Responsibilities
Quality System Support:
- Initiate, facilitate and/or manage projects to expand, change, enhance and improve the quality system, as assigned.
- Support the transfer of GxP records and documents from existing file server(’s) into the quality system software.
- Implement QMS updates as needed to comply with applicable FDA compliance requirements (ex. 21 CFR Part 11).
- Create, review and maintain quality system SOPs, records and other documents as assigned.
- Review and approved vendor related documents such as batch records, specifications, test methods, etc. as needed.
- Support Regulated Body audits (ex. FDA inspections).
- Provide quality system training for the organization.
- Provide support for regulatory compliance processes such as Adverse Events (AEs) assessments and execution.
- Work cross-functionally to lead investigations teams, root cause analyses and provide well-documented corrective and preventive action plans for identified issues.
- Other duties as assigned by supervisor.
- Support internal audits and vendor audits as needed.
- Maintain the audit schedule and audit files.
- Initiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions.
- Maintain monthly key quality measures related to the internal audit program.
- Develop metrics and perform trend analysis of audit findings to identify areas for improvement.
- Report on the status of the audit program, including the results of audits and corrective action status.
- Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities.
- Work with SME’s to ensure audit record content is accurate, well documented, and meets the requirement of the process.
Corrective and Preventive Action:
- Ensure that all CAPAs are entered into the quality system, assigned to the appropriate personnel, and completed according to CAPA procedures and within specified time periods.
- Maintain monthly key quality measures related to the CAPA process.
- Work with SME’s to ensure CAPA content is accurate, well documented, meets the requirement of the process, and is completed in a timely manner.
- Work cross-functionally to lead investigations teams and root cause analyses and provide well-documented corrective and preventive action plans for identified issues
Qualifications & Experience Desired:
- BA/BS required, with a preference in a scientific discipline.
- Minimum of 5 years of experience in pharmaceutical drug development, with the majority in the field of GMP quality systems in the biopharmaceutical industry. Demonstrated experience with quality assurance in the areas of Quality Systems, GCP and GLP is a plus.
- Extensive knowledge of FDA GxP regulations and guidance’s in the pharmaceutical and biopharmaceutical industry would be a plus.
- Excellent verbal and written communication skills, with the ability to shape, frame, and present to audiences.
- Ability to work with minimal supervision, set priorities, meet timelines, manage projects and motivate others.
- Excels in driving projects forward with acceptance by stakeholders for alignment on quality initiatives.
- Experience with various quality systems software’s. Specifically, with Verse Solutions or EtQ Software would be a plus.