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:
ultrafocused Work together to fearlessly uncover new possibilities
TheSenior Manager CMC QA willbe responsible forthe Product Complaints Annual Product Quality Review and CMC Change Control Review Board programs and willmaintainstrategic responsibility over QA Manufacturing Operations and will implement and communicate Ultragenyxs CMC quality approach for the company. This role will direct and oversee operationsin accordance withGxPregulations and Ultragenyx standards.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Facilitate Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC
- LeadUGXChange Control Review Board programand provide coaching to Change Ownerson the Change Control processas needed
- Support the release of production lotsin accordance withUltragenyx procedures
- Execution of Quality Systems in an Owner/SME or QA role for Deviations Change ControlsandProduct Quality Complaints
- Lead and activelyparticipatein Continuous Improvement initiatives and projects ensuring a focus on increasing both efficiency and quality output from all processes used by the CMC QA and cross-functional partners
- Design develop and review CMC QA standards and procedures (i.e. policy documents and SOPs). Review and support deployment of Quality Standards generated by the Quality System Department
- Support theProduct Complaints functionin investigating reportedproduct qualityeventsas needed
- Represent Ultragenyx to Health Authorities during inspections
- Ensure activities and deliverablescomply withFDA EMA and local regulations and guidance ICH guidelines Ultragenyx policiesSOPsand industry best practices.
- Communicate and promote a culture of quality and operational excellence
- Other duties as assigned
Requirements:
- ABachelorsdegree or equivalent work experience in QA Manufacturing Operations or related discipline.
- 8 years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality.
- Experience withmanagement of Change Control processand Review Board.
- Experience with Product Disposition.
- Demonstrate quality mindset and influences across the entire organization.
- Strong understandingunique quality and manufacturing expectations from other regulatory authorities such as EMA ANVISA MHRA etc.
- Expert knowledge of GMPs.
- Flexibility and the ability to manage change.
- Strong interpersonal skills and the ability to work well as part of a team.
- Demonstrated ability for analytical and systematic thinking.
- Experience with Product Complaint handling investigations and reportinga plus.
- Fosters an environment of accountability diversity andspeaking up.
- Demonstrated high personal and professional ethical standards.
- Travel up to10% oftotalwork hours.
#LI-CT1 #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
$174900 - $216100 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 .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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:.
Required Experience:
Senior Manager
Why Join UsBe 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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means goi...
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:
ultrafocused Work together to fearlessly uncover new possibilities
TheSenior Manager CMC QA willbe responsible forthe Product Complaints Annual Product Quality Review and CMC Change Control Review Board programs and willmaintainstrategic responsibility over QA Manufacturing Operations and will implement and communicate Ultragenyxs CMC quality approach for the company. This role will direct and oversee operationsin accordance withGxPregulations and Ultragenyx standards.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Facilitate Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC
- LeadUGXChange Control Review Board programand provide coaching to Change Ownerson the Change Control processas needed
- Support the release of production lotsin accordance withUltragenyx procedures
- Execution of Quality Systems in an Owner/SME or QA role for Deviations Change ControlsandProduct Quality Complaints
- Lead and activelyparticipatein Continuous Improvement initiatives and projects ensuring a focus on increasing both efficiency and quality output from all processes used by the CMC QA and cross-functional partners
- Design develop and review CMC QA standards and procedures (i.e. policy documents and SOPs). Review and support deployment of Quality Standards generated by the Quality System Department
- Support theProduct Complaints functionin investigating reportedproduct qualityeventsas needed
- Represent Ultragenyx to Health Authorities during inspections
- Ensure activities and deliverablescomply withFDA EMA and local regulations and guidance ICH guidelines Ultragenyx policiesSOPsand industry best practices.
- Communicate and promote a culture of quality and operational excellence
- Other duties as assigned
Requirements:
- ABachelorsdegree or equivalent work experience in QA Manufacturing Operations or related discipline.
- 8 years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality.
- Experience withmanagement of Change Control processand Review Board.
- Experience with Product Disposition.
- Demonstrate quality mindset and influences across the entire organization.
- Strong understandingunique quality and manufacturing expectations from other regulatory authorities such as EMA ANVISA MHRA etc.
- Expert knowledge of GMPs.
- Flexibility and the ability to manage change.
- Strong interpersonal skills and the ability to work well as part of a team.
- Demonstrated ability for analytical and systematic thinking.
- Experience with Product Complaint handling investigations and reportinga plus.
- Fosters an environment of accountability diversity andspeaking up.
- Demonstrated high personal and professional ethical standards.
- Travel up to10% oftotalwork hours.
#LI-CT1 #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
$174900 - $216100 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 .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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:.
Required Experience:
Senior Manager
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Job Location:
Monthly Salary:
$ 174900 - 216100
Posted on:
10 hours ago
Vacancies:
1 Vacancy
