Senior Training Specialist, QA, GMP Training

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

The Senior Training Specialist will assist in the execution of 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 support training curricula design and deployment across the sites and support design and deployment of training materials to enhance learning and understanding of relevant GMP procedures and processes. This role will also support daily LMS administration tasks.

Work Model:

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

Responsibilities:

1. Execute 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.

2. Support development of trainings and coordinate delivery of the training as applicable.

3. Execute the development of training curriculum to ensure consistency and effectiveness.

4. Support Quality System metrics to measure the health and effectiveness of training. Proactively identify, escalate, and address negative trends.

5. Support deviation investigations and CAPA planning that may require instructor-lead training

6. Daily monitoring and administrative tasks for Service Now tickets as they are related to Compliance Wire.

7. Organize and facilitate periodic review for New Hire Orientation training materials and present training to newly hired personnel.

8. Participate in audits/site inspections as the SME for training.

9. Support the Global Training (Quality System) teams to drive continuous improvement to the training processes

Requirements:

1. Associate degree in Training, Biological Sciences, Biotechnology, Bachelor degree preferred or equivalent experience.

2. Minimum of 3-5 years working in a regulated environment (pharmaceutical, biotech, life sciences or healthcare) or equivalent experience/education.

3. Proficient in cGMP requirements and expectations.

4. Experience in training program administration

5. Proficiency with LMS platforms

6. Knowledge of regulatory training requirements and risk-based training approaches

7. Excellent communications skills, both written and verbal.

8. Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.

9. Creativity, energy and passion for training adults to improve understanding.

#LI-CS1 #LI-Onsite

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range$95,600—$118,100 USD  Full Time employees across the globe enjoy a range of benefits, including, but not limited to:   ·         Generous vacat