Senior Director, Quality Assurance *PC 1497

Your Role:

This position is primarily responsible for ensuring that all aspects of the quality management system are effectively established, implemented and maintained within the Miltenyi Gaithersburg site in accordance with US-FDA, Health Canada, EU and other applicable regulations.

Essential Duties and Responsibilities:

• Manage the Quality organization (Quality Assurance and Compliance) responsible for results in terms of product quality, conformance to regulations and Company policies.
• Act as the Management Representative for Quality for the site.
• Oversee Quality Assurance functions including final product release, exception management, product complaint handling, manufacturing process monitoring activities, internal/external audits, CAPA activities, change control and supplier qualification.
• Assure that there is strict adherence to cGMPs in clinical products manufacturing.
• Assure that quality documentation is maintained with integrity, including equipment master files, personnel training files, controlled material files and document control files.
• Author, review and approve relevant documentation, including SOPs, SMPs, BPRs, Quality Manual, Protocols and Quality Agreements related to cGMP activities
• Develop Quality staff by creating departmental and individual goals, recognizing and celebrating success and providing coaching and feedback to improve performance.
• Develop a commercial ATMP drug product Quality organization supporting highly digitalized workstreams and product releases.
• Lead regulatory inspections and interfaces with Regulatory agencies on Quality matters.
• Frequently interact and communicate with potential and existing clients through established corporate channels. Ensure client requirements are met in a timely manner.
• Partner with manufacturing and business leaders to continuously improve processes.
• Fiscal responsibility for the Quality Department budget.
• Oversee the Validation/Calibration component of the Quality organization, ensuring that the equipment is adequately qualified, serviced and calibrated against recognized standards.
• Implement and maintain MasterControl as an electronic Quality Management System

Requirements:

• Bachelors/ master's degree in health science, Life science / engineering or medical field or equivalent; A minimum of 15 years' experience in the pharmaceutical or biotechnology industry with experience in Quality Assurance, Compliance, or related fields in biopharmaceutical products; or equivalent combination of education and experience.
• Typically requires 5-8 years of managerial 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.
• Analytical problem-solving skills with impeccable attention to detail.
• Excellent communication, interpersonal, and collaborative skills.
• Must be able to interact with Manufacturing and QC on a peer basis.
• Ability to collaborate and build a consensus in a high-pressure environment.

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.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.