Associate Director, Quality Systems GxP Global Learning
Company: Disability Solutions
Location: Brisbane
Posted on: November 19, 2023
Job Description:
Why Join Us?Be a hero for our rare disease patientsAt
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
challengesThe GxP Global Learning role will contribute to the
success of the business strategies and employee satisfaction by
standardizing, optimizing and innovating learning and training as
well as enhance employee competencies. This role brings subject
matter expertise and experience along with best practice knowledge
to lead the development and implementation of the learning and
development program which encompasses use and optimization of the
Quality Management System. This position resides within the Quality
organization and spans across the entire Ultragenyx enterprise. It
provides continuous improvements within the training environment
and the selected candidate will be a champion of the Quality
Culture at Ultragenyx. Work Model: Flex: This role will typically
require onsite work 2-3 days each week, or more depending on
business needs. In many locations, the business will set certain
days each week that Flex employees are required to be onsite.
Responsibilities:
- Lead the business process development and evolution (as the
Ultralearning Business System Owner) ensuring effective use of
Compliance Wire LMS and system enhancements with IT as a
partner.
- Lead and/or support the assessment, development, delivery, and
maintenance of the department training program, documentation, and
curricula within the Learning Management System (LMS) in support of
the Quality Management System, employee onboarding learning plans
and contractor training program. This includes management of the
Annual GxP refresher program.
- Manage the implementation and maintenance of the Quality
Standard for Personnel Qualification and it corresponding SOPs,
Work Instructions and or Forms
- Coordinate with administrators and area training leads for
content development, change management, training implementation and
continual improvements to the Learning and Development processes
and tools.
- Provide tactical support and/or present as SME regarding
training programs, systems, and records during internal/external
audits and health regulatory inspections.
- Maintain metrics that measure the health of GxP Learning, QMS,
QRM and SQM by mastering tools such as Power BI. Continually
improve measurement mechanisms. Requirements:
- Bachelor's Degree required in Biological Sciences, Chemistry,
Engineering or related technical discipline, degree or training in
adult leaning deployment is a plus.
- Minimum of 6 years developing and deploying training, with a
minimum of 3 in the GxP environment supporting a Quality
Organization.
- Strong experience with the management and operation of Learning
Management Software.
- Strong experience and passion for data analysis tools and
dashboards including Power BI as a plus.
- Proficient in Global cGMP's, regulatory awareness and
pharmaceutical industry trends and practices.
- Exceptional teamwork and collaboration skills conducive of
creative problem-solving. #LI-CZ1 #LI-Hybrid 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 $173,600 - $214,400 USDDuring the COVID-19
pandemic, we are committed to the health and safety of our
employees and prospective employees, which means at this time our
interview processes may include virtual discussions, interviews,
and onboarding. Please note that compliance with local regulations
and safety protocols is a condition of employment at Ultragenyx.
Elements of safety protocols may include, but are not limited to:
work from home requirements, regular or symptom-based covid
testing, providing valid evidence of vaccination, mask wearing, and
physical distancing. US based roles: Full vaccination against
COVID-19 is a condition of employment at Ultragenyx. This
requirement applies to almost all roles at Ultragenyx based in the
U.S., with very limited exceptions. If you are unable to receive a
COVID-19 vaccine due to a disability, serious medical condition, or
because it would violate your sincerely held religious belief, you
will have an opportunity to request a reasonable accommodation.
Roles based outside the US: If the role requires travel to the US
or another country that requires evidence of covid vaccination for
entry, candidates and employees will be required follow the local
regulations and corporate policy regarding vaccination evidence
submission. Full Time employees across the globe enjoy a range of
benefits, including, but not limited to: --- Generous vacation time
and public holidays observed by the company --- Volunteer days ---
Long term incentive and Employee stock purchase plans or equivalent
offerings --- Employee wellbeing benefits --- Fitness reimbursement
--- Tuition sponsoring --- Professional development plans *
Benefits vary by region and countryUltragenyx 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. Reasonable accommodation will be
provided for qualified individuals with disabilities, and for
qualified disabled veterans, as required by applicable law.
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 calling (415) 483-8800 or emailing us
at talentacquisition@ultragenyx.com .See our CCPA Employee and
Applicant Privacy Notice . See our Privacy Policy .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 .
Keywords: Disability Solutions, San Francisco , Associate Director, Quality Systems GxP Global Learning, Executive , Brisbane, California
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