- Location
- Bedford, MA
- Workplace
- Onsite
- Department
- Compliance
- Seniority
- Senior
- Experience
- 15+ years
- Source
- Greenhouse
Description
Position Summary:
ultradedicated – Your biggest challenges yield rare possibilities
We are seeking a dynamic and experienced Senior Director of GMP Inspection Management to lead the development and implementation of a global inspection readiness and management program. The role is accountable for the strategic direction of all inspection management and readiness activities across the Ultragenyx network. This role will be responsible for ensuring consistent, proactive, and risk-based inspection readiness across internal manufacturing and testing operations, as well as external Contract Manufacturing Organizations (CMOs). The ideal candidate will bring deep expertise in GMP compliance, regulatory inspections, and cross-functional collaboration to drive a culture of continuous improvement and inspection excellence.
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:
Global Inspection Strategy & Readiness
- Design and implement a comprehensive global GMP inspection management framework and governance.
- Lead inspection readiness initiatives across internal and external manufacturing and testing sites.
- Develop and maintain inspection storyboards/playbooks, mock inspection protocols, and response templates.
- Develop and monitor inspection management and readiness performance metrics.
Inspection Execution & Management
- Serve as the global lead for regulatory GMP inspections (FDA, EMA, PMDA, etc.), including hosting, coordination, and response management.
- Oversee inspection logistics, real-time support, and post-inspection follow-up activities.
- Ensure timely and effective CAPA development and implementation.
External Manufacturing Oversight
- Partner with Quality, Manufacturing, and Supply Chain teams to ensure CMO sites are inspection ready.
- Conduct inspection readiness assessments and support CMOs during regulatory inspections.
- Harmonize inspection practices and expectations across external partners.
Training & Continuous Improvement
- Develop and deliver inspection training programs for SMEs and site leadership.
- Analyze inspection trends and regulatory intelligence to inform risk mitigation strategies.
- Drive continuous improvement in inspection readiness processes and tools.
Leadership & Collaboration
- Lead cross-functional inspection readiness teams and governance forums.
- Collaborate with Global Quality, Regulatory Affairs, and Compliance teams to align on inspection strategy.
- Represent the company in external forums and industry groups, as appropriate.
Requirements:
- Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
- 15+ years of experience in GMP compliance, quality assurance, or regulatory affairs within the biopharmaceutical industry.
- Proven track record of leading global regulatory inspections and readiness programs.
- Strong knowledge of global GMP regulations and inspection practices.
- Experience with both internal operations and external manufacturing oversight.
- Excellent communication, leadership, and project management skills.
- Ability to influence across levels and functions in a matrixed organization.
- Experience with biologics or gene therapy manufacturing.
- Prior experience working with global CMOs and managing complex supply chains.
- Familiarity with digital tools for inspection management and quality systems.
- Up to 25% travel may be required (domestic and international).
#LI-KJ1 #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.
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 [email protected].
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.
