Ultragenyx

Senior Director, QA Operations

Posted 2 Days Ago

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Novato, CA

251K-310K Annually

Senior level

Biotech

The Role

The Senior Director of QA Operations will oversee global quality assurance activities, manage product quality operations in compliance with GxP regulations, and lead a team to ensure product quality from manufacturing to distribution. Responsibilities include overseeing quality metrics, handling complaints, and representing the company during inspections.

Summary Generated by Built In

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 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:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, QA Operations will oversee and manage global quality assurance activities within the Ultragenyx CMC organization. This role will be responsible for the quality oversight of product manufactured at Contract Organizations for early and late stage clinical programs as well as commercial product. The Sr Director, Quality Operations will maintain and lead continuous improvement of the Product Disposition and Product Quality Complaint Management systems. The successful candidate will ensure product quality operations is compliant with applicable GxP regulations, ICH guidelines, Ultragenyx standards, and industry best practices. This role requires the ability to manage performance and development of direct reports to ensure achievement of organizational and department goals in an engaging and productive environment.

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:

Ensure on time disposition of Ultragenyx’s multi-product Biologics and Small Molecule portfolio in compliance with cGMPs across various manufacturing stages including cell banks, drug substance, drug product, and finished product
Coordinate with internal and external Qualified Persons (QP) activities related to QP batch confirmation and batch certification including support of QP queries, QP declarations, and creation and maintenance of the Product Specification File
Provide Product Disposition quality oversight for New Product Introduction and new country launches in collaboration with CMC teams for management of Supply Chain Maps and compliance to country specific distribution requirements
Develop, maintain, and enhance Quality Management transactions in Oracle in adherence with global regulatory requirements and serve as the QA representative on Oracle enhancement projects
Develop and maintain Product Disposition metrics that measure and enhance the performance and health of the Product Disposition quality system and present to Sr Leadership periodically at the Global Quality Systems Management Review
Ensure significant quality risks are escalated and mitigated in a timely manner
Manage the Global Product Quality Complaint Handling Unit and drive enhancements to the overall program
Act as Product Recall coordinator as required
Facilitate Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC
Represent Ultragenyx to Health Authorities during inspections
Communicate and promote a culture of quality and operational excellence
Other duties as assigned

Requirements:

BS degree in a scientific/technical discipline is required, advanced degree preferred
Minimum of 15 years’ experience in a GxP biotechnology or pharmaceutical environment is required, Biologics and Small Molecule experience preferred
Minimum of 8 years’ experience in Quality in a CBER/CDER regulated industry
Minimum of 8 years’ experience leading and developing high performing teams
Proficiency in Oracle is desired
Expert knowledge of cGMP compliance regulations and industry practices
Demonstrated quality mindset and ability to influence across a matrix organization
Ability to manage multiple priorities and aggressive timelines
Experience with Veeva electronic quality management system (eQMS) is a plus
Travel: approximately 5% #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 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

$250,800—$309,800 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 [email protected].

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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: [email protected].