Director, Quality Assurance (Warehouse Operations)

Bedford, MA, United States

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**Director, Quality Assurance (Warehouse Operations)**

Bedford, MA / Ultragenyx UGT Project Vector QA / Full-time *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 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 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. *During the COVID-19 Outbreak, we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.*

*US based roles: starting on January 3rd, 2022, full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.*

**Position Summary** ***ultra***impact Make a difference for those who need it most *Ultragenyx has multiple Gene Therapy programs in development in the rare and ultrarare disease space, a robust pipeline. We are building a state of the art GMP manufacturing facility in Bedford, MA. Join our team!* As the Director, Quality Assurance Warehouse Operations you be responsible for QA oversite of the warehouse and supply chain production processes at the new gene therapy manufacturing facility located in Bedford, MA. During the construction and qualification phases this will be a critical role in establishing the quality oversight for processes such as material receipt, material release, and material management while interfacing with the ERP system. As the warehouse becomes operational, activities will evolve to include deviation management, change record management, supplier management, and disposition of materials for manufacturing use. The site is a multi-product facility which will be used for cell banking, drug substance manufacturing, drug product manufacturing, and packaging / labeling operations. Your role will partner with the Supply Chain / Warehouse, Manufacturing, Engineering, Validation, and Quality Control functions to develop the operating procedures and warehouse processes for the qualification and readiness of the facility. As the facility startup progresses you will work closely with these teams to support initial engineering runs and transition to routine manufacturing at the site. You will be responsible for quality decisions related to material movement, supplier management, and multi-product material controls at the site. You will report to the Executive Director, Quality Assurance at Ultragenyx Gene Therapy. Core Lab & Ops: Your role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic. **Responsibilities**

+ Build a mindset of quality risk management applicable to routine activities and daily decision-making processes for early and late stage clinical products produced at the site. Perform formal risk assessments as applicable.

+ Responsible for writing, reviewing and/or approving documents such as SOPs, work instructions, quality agreements, and standards to enable the execution of GMP warehouse operations.

+ Work with various functions to resolve deviations and assess potential material and compliance impact. Escalate significant events to Sr. Leadership and drive timely completion of investigations.

+ Responsible for developing, reviewing and approving ERP processes (and metadata) to ensure seamless integration and accuracy with manufacturing operations and batch disposition.

+ Provide leadership to site change control review board (CCRB). Support the change control processes by assessing, reviewing, and approving change control requirements.

+ Develops and monitors Quality Metrics associated with materials and suppliers; support periodic reviews of suppliers and drive process improvement activities as applicable.

+ Support regulatory inspections and ongoing inspection readiness efforts. Lead or support strategies to achieve readiness and address compliance risks.

+ Drive or support continuous improvement activities to support elimination of waste to enable an effective and efficient manufacturing site. Champion process improvement where applicable.

**Requirements**

+ Minimum B.S. degree; preferably in scientific or engineering field.

+ 8+ years of experience in GMP regulated industry (preferably biopharmaceutical, biotechnology, cell or gene therapy industries) with roles in Supply Chain, Manufacturing or Quality. Quality experience preferred.

+ Direct experience working at a biologic or advanced therapy pharmaceutical manufacturing site. Knowledge and experience with drug substance, aseptic processing, and packaging.

+ Comprehensive knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products.

+ Demonstrated ability to communicate technical information or complex situations to senior leadership and/or health authority inspectors in a concise and clear manner.

+ Travel may be required up to 10%. Ability to travel to other Boston-area locations for larger team meetings

**Management Skills**

+ **Clarify Direction & Priorities**: Set clear direction for your direct reports aligned with functional and corporate goals. Reprioritize work, as needed. Enable others to do their job well by communicating information and making decisions in a clear, timely manner.

+ **Partner & Collaborate Effectively**: Listen to and value others thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.

+ **Support Learning & Growth**: Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others.

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*Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at* *[email protected]**. For electronic email and mail inquiries, please include a des

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