Associate Director, Quality Assurance GMP Training Management
Associate Director, Quality Assurance GMP Training Management
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Job Description
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
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.
Work Model:
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:
- Minimum of a Bachelors 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.
Physical Demands
- 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).
#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 applicants 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
$175800 - $217100 USD
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 us at .
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.
Required Experience:
Director
Employment Type
Full Time
