Director, Site Quality Assurance *PC 474

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry — our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.

Director, Site Quality Assurance 

Gaithersburg, MD

Your Tasks:

This position is primarily responsible for ensuring that all aspects of the quality management system are effectively established, implemented and maintained in accordance with FDA regulations and guidance documents, and all other applicable laws. This position is responsible for Site GMP compliance for relevant operations carried out within and for the Miltenyi Biotec site and its clients, including activities related to preclinical and clinical supply of investigational cell therapy products. 

Essential Duties and Responsibilities:

• Develop and implement phase appropriate Quality standards and practices in support of process development and clinical manufacturing activities.
  
• Lead QA functions related to the development, manufacture, storage, and distribution of clinical products.
  
• Review and approve master batch records, test methods, specifications and SOPs to ensure compliance to quality standards.
  
• Ensure timely release of investigational products in alignment with clinical program timelines.
  
• Work cross-functionally to ensure timely resolution of deviations related to product release.
  
• Partner with manufacturing and business leaders to drive continuous process improvement within the GMP QA operational unit.
  
• Lead and facilitate authority inspections, internal and external supplier, and client audits.
  
• Write and review Quality Systems policies and SOPs related to functional responsibilities.
  
• Assist in preparation of CMC sections of regulatory submissions.
  
• Manage the product complaint handling process. Lead, conduct and oversee timely reporting, evaluation, and follow-up of product complaints.
  
• Provide QA guidance related to analytical methods and process technology transfer. Create dedicated documents from across functions for this purpose.
  
• Develop site Quality Team by creating departmental and individual goals, recognizing and celebrating success and providing coaching and feedback to improve performance.

Requirements:

• Bachelor's degree in health science, Life science / engineering or medical field or equivalent; A minimum of 8-10 years' experience in the pharmaceutical or biotechnology industry and 8+ years of experience in managing QA functions; or equivalent combination of education and experience. 
• In depth knowledge of the regulatory environment (FDA, ICH, EU) for the manufacture of medicinal or investigational products, specifically aseptically filled products.
  
• Strong leadership skills and demonstrated success in managing a large team.
  

Skills:

• Excellent communication, interpersonal, and collaborative skills.
  Must be able to interact with Manufacturing and QC on a peer basis.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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.  The employee must occasionally lift and/or move up to 25 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.