drjobs Manager, QC Systems

Manager, QC Systems

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1 Vacancy
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Job Location drjobs

Woburn, MA - USA

Monthly Salary drjobs

$ 122100 - 150800

Vacancy

1 Vacancy

Job Description

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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont 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 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 andpersonally come join our team.

Position Summary:

This position is in the Ultragenyx Gene Therapy Quality Control Systems group. The primary functions of the Quality Control (QC) Manager will be to lead own and support Investigations/Quality Systems in support of Quality Control and manage key aspects of the analytical method lifecycle. The individual will operate as an independent contributor working collaboratively and closely with QC and QA peers to establish/maintain a high bar of quality mindset/quality culture within the Quality Control organization.

ultraimpact Make a difference for those who need it most

Work Model:

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

Responsibilities:

  • Lead and support complex technical investigations related to Quality Control (e.g. Out of Specification Out of Expectation Trend Investigations etc.)
  • Manage key aspects of the analytical method lifecycle including but not limited to:
    • Coordinate and author invalid trend reports
    • Coordinate the execution of annual analytical method performance trending reports
  • Own and facilitate Change Control and CAPAs in support of Quality Control operations
  • Provide coaching and training to junior analysts for deviations root cause analysis change control and CAPAs
  • Support the establishment tracking and communication of key performance indicators (KPIs) and other key operational metrics both internally to QC and to other UGT stakeholders within the organization
  • Support a matrixed organization by cross training to support Quality Control enterprise systems (e.g. LabVantage LIMS and Learning Management System) as needed
  • Model leadership behaviors and mentor/train junior staff

Requirements:

  • Bachelors or Masters degree in Biology Chemistry or equivalent
  • Minimum 5-8 years of experience in the biotech industry
  • Demonstrated experience authoring and owning simple and complex Quality Systems (Deviation Change Control and CAPA)
  • Expertise in project management both individually and within teams is essential
  • Demonstrated written and oral communication skills at individual team and organizational levels
  • Possesses strong time management skills
  • Experience working on cross-functional teams and managing relationships in collaborative constructive manner with internal stakeholders required
  • Independently motivated detail oriented and strong problem-solving ability

#LI-AJ1 #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 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

$122100 - $150800 USD

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 country

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 .


Required Experience:

Manager

Employment Type

Full Time

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