Associate Director, Quality Assurance GMP Training Mgmt.

Associate Director, Quality Assurance Gmp Training Mgmt

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.

Responsibilities :

• 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.

Requirements :

Physical Demands :

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.

$175,800 - $217,100 USD

Full Time employees across the globe enjoy a range of benefits, including, but not limited to :

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and / or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing talentacquisition@ultragenyx.com.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters : All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees / hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to talentacquisition@ultragenyx.com.