Associate Director, Quality Assurance GMP Training Management

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This role will provide Quality Assurance oversight for Training Management related to internal GMP operations at both the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA and the Quality Control Laboratories located in Woburn, MA. This role will ensure training curricula is adequately designed and deployed across the sites. It will design and deploy training materials to enhance learning and understanding of relevant GMP procedures and processes. It will champion a strong Quality Mindset by ensuring a robust understanding of core cGMPs concepts and skills have been engrained in all personnel performing activities at the sites.

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

• Lead Instructor Led Training activities for core cGMP concepts such as Good Documentation Practices, Data Integrity, and Quality Mindset. Develop and deliver periodic or focused training.
• Work closely with Site Leaders to identify needs for enhanced training to proactively or reactively address trends, changes, or gaps. Develop training and coordinate delivery of the training as applicable.
• Facilitate the development of training curriculum to ensure consistency and effectiveness. Oversee the management and completion of training.
• Develop and maintain Quality System metrics to measure the health and effectiveness of training. Proactively identify, escalate, and address negative trends.
• Support deviation investigations and CAPA planning that may require instructor-lead training.
• Be proficient with the Ultragenyx Learning Management System (LMS) to make revisions, provide reports, and conduct analysis on training performance.
• Work with the Global Training (Quality System) teams to drive continuous improvement to the training processes.

• Minimum of a Bachelor’s Degree in a science, engineering, or related technical discipline.
• Degrees or training associated with adult learning, training development, or training management is preferred.
• 8+ years of experience developing and deploying training, with a minimum of 4 years in a GxP environment supporting a Quality Organizations.
• Strong experience with the management and operation of Learning Management Software (or similar type of system).
• Proficient in cGMP requirements and expectations.
• Proficiency with data analysis tools to identify trends.
• Excellent communications skills, both written and verbal.
• Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
• Creativity, energy and passion for training adults to improve understanding.
• Travel may be required up to 10%. Most travel will be between Ultragenyx locations located in Boston or San Francisco areas.

• Stand for extended periods of time with periodic stooping / bending / kneeling
• Able to lift, push, pull up to 50lbs.
• Climb ladders and stairs of various heights.
• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
• Certain tasks may require the use of a respirator; medical clearance will be required in advance.
• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment.
• Working in temperature-controlled environments (cold rooms).

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