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