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 and GVP compliance. The role will work in collaboration with the Miltenyi Global Quality Organization.

Essential Duties and Responsibilities:

• Ensuring that clinical trials and pharmacovigilance processes comply with applicable regulatory requirements, industry guidelines, and internal quality standards.
• Executing assigned GCP and GVP audits in line with the Global CQA Audit Program.
• Planning and conducting audits of internal processes and procedures, clinical investigator sites, CROs and contract clinical laboratories, clinical databases, and study reports to assess compliance with relevant guidelines, legal requirements and GCP/GVP.
• Providing clinical teams with advice regarding applicable GCP/GVP and compliance related issues and questions.
• Supporting and facilitating regulatory agency inspections.
• Supporting maintenance and continuous improvement of Global Clinical Quality System.
• Support the development, implementation, and maintenance of quality systems within clinical research programs and pharmacovigilance, working closely with cross-functional teams to promote a culture of compliance and continuous improvement.
• Create, maintain and review relevant quality documents such as policies, standard operating procedures and other quality records, as well as templates and flow charts.
• You will work closely with, and report to, the Director of Global Quality Assurance and represent the client's QA topics in the field of work within the company.
• Assist with regulatory inspections and readiness activities, including preparation, hosting, and follow-up.
• Keep the right documents up to date (like SOPs) and follow the right processes.
• Monitor and report quality metrics and trends to support decision-making and risk management.
• Collaborate with clinical, pharmacovigilance, regulatory, and operational teams to ensure quality standards are embedded throughout the clinical development lifecycle.
• Stay current with evolving regulatory requirements, industry best practices, and QA trends.

Requirements:

• Bachelor's Degree required (Masters preferred), ideally in biosciences or pharmacy; Minimum 5 years of experience in Clinical QA experience with relevant background in the pharmaceutical or biotechnology industry, including GCP/GVP regulatory inspections; Or a combination of education and experience. 
• Knowledge of tools and technologies used for automating workflows and processes (e.g. VEEVA-VAULT, Ennov, SharePoints).
• Quality-First mindset and good knowledge of FDA/EU GCP/GVP and as well as applicable standards (e.g. ICH GCP).
• Experience in collaborating with interdisciplinary teams and representing QA topics to internal and external stakeholders.
• Excellent organizational and analytical skills.
• Personal responsibility, structured working methods.
• Highest levels of integrity and commitment to building Miltenyi Biomedicine reputation in the industry.
• Exemplary corporate citizen with technical expertise in ethics, quality and compliance.
• Excellent verbal, written and interpersonal communication skills.
• Analytical skills to manage trending and associated process improvements.
• Strong collaboration and negotiation skills.
• Work independent with little supervision required.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions