Senior Manager, Clinical QA & GxP Compliance
Senior Manager, Clinical QA & GxP Compliance
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Job Description
Position Summary:
The primary responsibility of this role is to provide oversight of GCP activities which include but are not limited to: ensuring patient safety data integrity and compliance with SOPs GCP and applicable regulations. Additional responsibilities include execution of the GCP Audit Plan as well as support of Inspection Management goals and objectives.
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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:
- Plan conduct or manage and report results for GxP audits which includes but is not limited to internal processes clinical investigational sites clinical vendors CSRs and TMFs
- Train coach and oversee Clinical QA personnel subject matter experts (SMEs) and/or other contract service provider(s) in preparing conducting and reporting of GxP audits as assigned
- Actively support inspection readiness activities associated Health Authority Inspections and perform assigned War Room leadership role through the following:
- Participate in cross functional teams to identify GxP inspection risks and lead activities to mitigate and defend business processes for example through storyboard process
- Identify and communicate potential risks
- Develop and deliver inspection training for SMEs and War Room support team members
- Lead partnerships with key stakeholders to deliver forward-thinking programs and training facilitating a state of inspection readiness
- Review GCP-associated controlled documents which may include standard operation procedures (SOPs) protocols/amendments study-specific documents such as study or data management plans etc. in accordance with applicable regulatory requirements (e.g. ICH E6 U.S. FDA EMA and local regulations)
- Provide guidance and support to internal departments and Clinical Study teams (during all phases of clinical development) in the identification and investigation of potential GCP and compliance issues including those at clinical investigator sites with internal Ultragenyx processes and with vendors conducting GCP activities
- Ensure appropriate and timely solutions for corrective and preventive actions are implemented at sites or vendors when needed to secure compliance and maintain a state of inspection readiness
- Ensure proper evaluation and completeness of deviation/CAPA entries; project manage process to ensure timely completion and closure of deviations/CAPAs to ensure triage and report metrics and trends to management
- Perform any other tasks as requested by Clinical QA and/or Executive Management to support Quality oversight activities
Requirements:
- Bachelors Degree is required in a scientific or related technical discipline
- At least 7 years experience in Biotech/Pharmaceutical industry Quality Assurance experience preferred
- Strong working knowledge and interpretation of global GCPs particularly U.S. FDA / EU and ICH regulations and guidelines
- Able to execute quality goals over a 1-2 year period that aligns to company-wide objectives
- Excellent communications skills both written and verbal
- Flexible in the face of shifting needs and/or priorities
- Motivated committed and self-managed
- Travel up to 30% of the time
#LI-CS1#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
$171200 - $211500 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:
Senior Manager
Employment Type
Full Time
