Associate Director, Biomedicine Clinical Quality Assurance *PC 1485

Your Role: 

The role will provide quality assurance and clinical compliance support to the MBM USA team for global GCP compliance, regulatory and MBM procedures compliance. The role will work in collaboration with the Miltenyi Global Quality Organization.

Essential Duties and Responsibilities: 

Quality Compliance

• Support and ensure that all relevant legislation is fully addressed in Miltenyi Biomedicine policies, procedures, programs and training in MBM US
• Assist clinical team to address compliance questions and help to implement required guidelines and processes.
• Assure relevant GxP requirements and MBM internal procedures are followed.
• Assure cooperation and conformance with the global Miltenyi Quality Management System (QMS).
• Support the collection of metrics for monitoring compliance effectiveness.
• Support the embedding of a quality compliance culture into everyday Miltenyi Biomedicine processes in MBM Inc proportionate to the position and in alignment with wider Miltenyi Biomedicine global QA and operations.
• Develop and update procedures as applicable to meet the local regulatory requirements.
• Participate in project / program team meetings and relevant activities to provide compliance guidance as applicable.
• Advise operational teams on risks identification, mitigation and remediation actions.
• Support operational teams in vendor management from the quality standpoint.

SOPs / Quality Control of Documents

• Support the system for quality assurance of documents according to GxP and other regulatory requirements within Miltenyi Biomedicine US and in accordance with the global Miltenyi QMS. 
• Support and organize development of SOPs.
• Support the update of SOPs and MBM procedures.
• Support the harmonization of the global processes.

Change Control 

• Support the Change Control System.
• Support recording and monitoring of planned changes.
• Promote and support the effective use of Change Requests for impact assessment and implementation planning.
• Record and report on Change Control metrics.
• Support product release process.

Training Management

• Support the compliance-related training program for Miltenyi Biomedicine personnel in the US.
• Support the training development and delivery process for Miltenyi Biomedicine SOPs including implementation plans and the development of training materials for MBM Inc in the US.
• Support and ensure the maintenance of organization charts and GXP CVs which underpin regulatory/ client demonstration of the use of qualified personnel.
• Support the assignment of training modules to the curriculum.
• Support the maintenance of a training tracker for the recording of assigned trainings.
• Support the production of training completion reports and statistics.

Support audits and Inspections

• Support risk based annual audit plans.
• Support internal audits according to the annual internal audit plan where necessary.
• Support inspection readiness via training, audit response teams, mock inspections, and hosting audit/ inspection events in MBM Inc in the US.
• Develop study specific audit plans based on protocol profile and risks.
• Oversee outsourced audits for clinical sites and / or service providers. Ensure audit closure and follow up.
• Host, manage and follow up local regulatory inspections including supporting sites and liaising with service providers.

CAPA Management 

• Ensure CAPAs are created resulting from audit / inspection reports or Complaints / Deviations as applicable 
• Support root cause analysis and risk assessment with MBM QA and business lines and assist in assigning mitigation responsibilities for CAPAs.

Support Complaint and Deviation Management 

• Ensure that complaints and deviations are performed according to the respective process 
• Support recording and monitoring deviations / breaches and unplanned deviations 
• Trend deviations and provide continuous improvement support to functions.