Associate Director, Analytical Quality Assurance at Ultragenyx in Bedford, MA

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:

The Associate Director, Analytical Quality Assurance, will partner with team members across Quality Assurance, Quality Control, and Technical Operations to ensure effective, efficient, and compliant operations exist at our GMP facility. The individual will nurture and reinforce the Ultragenyx Responsible Quality Mindset and Quality Culture at UGT (Ultragenyx Gene Therapy). This role will be responsible for Quality Assurance oversight of QC Environmental Monitoring and Raw Materials activities related to GMP operations at the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA. Core activities including approval of applicable procedures, work instructions and records directly related to QC Environmental Monitoring and Raw Materials and driving the completion of robust deviations (investigations), CAPA, and change controls associated with the QC and AQA groups at GTMF. This role will also manage the performance and development of direct reports to support these activities.

ultraimpact – Make a difference for those who need it most

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site

Responsibilities:

Provide Quality Assurance oversight for Analytical Quality Assurance to deploy and manage processes that ensure compliance with the QC Environmental Monitoring and Raw Material areas
Approve applicable procedures, work instructions and records directly related to QC Environmental Monitoring and Raw Materials
Write, review and/or approve deviations (investigations), CAPA, and change controls associated with the QC and AQA groups at GTMF
Ensure the appropriate capabilities; procedures and quality mindset are in place to ensure GMP with a focus on data integrity / analysis and management
Provide active support for QC EM and RM operations inclusive of associated facilities, lab operations and IT operations
Facilitate resolution of facility excursions by participating in the cross-functional review committee
Ensure raw materials sampling and testing programs are operating in an appropriate state for the product lifecycle stage
Manage and administer all aspects of people processes related to the employee life cycle. Coach and develop staff, set realistic personal goals for self and staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities
Participate in inspections and audits for various roles as assigned

Requirements:

Minimum B.S. degree in a scientific field such as microbiology, chemistry or biochemistry
8+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries within Quality roles. 2+ years of Quality leadership/management experience
Demonstrated experience with creating and implementing effective cGMP quality systems, inclusive of writing SOPs, work instructions, maintenance procedures, and maintenance plans
Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections
Excellent communications skills, both written and verbal
Excellent teamwork, interpersonal skills and negotiation skills
Willingness to work in a dynamic and changing corporate environment. Flexible in the face of shifting needs and/or priorities
Travel may be required up to 10%. Most travel will be to other Boston-area locations for larger team meetings

#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$180,300—$222,700 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 talentacquisition@ultragenyx.com.

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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: talentacquisition@ultragenyx.com.