Associate Director, Quality Assurance Operations Downstream 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:

ultrafocused – Work together to fearlessly uncover new possibilities

The primary responsibility is the Quality oversite for Drug Substance manufacturing of gene therapy products. The role will provide "on the floor" oversite of downstream purification manufacturing activities. These activities include "on the floor" guidance during unexpected events, batch record review, room clearance, and deviation, change control management and drug substance disposition support activities. You will partner with Manufacturing, Facilities, MSAT, Validation, and Quality Control to support manufacturing and product release activities or ongoing projects/initiatives. You will provide quality expertise to ensure compliant manufacture of GMP material (clinical or commercial). Operational excellence initiatives must be supported and driven from this level. You will be required to work independently since the role requires limited supervision and guidance.

Work Model:

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

Responsibilities:

Provide on the floor quality operations support for all areas and own the master batch record lifecycle processes including final review and approval.
Provide technical quality guidance as part of teams conducting investigations for complex manufacturing events; ask the tough questions and drive robust root cause analysis, product impact assessments, and risk based CAPA.
Review and approve complex deviations and/or Investigations that are site specific
Actively support and/or lead preparation activities for Pre-approval Inspections and/or responses to observations.
Work with product release teams to support issuance of drug substance Certificates of Conformance and any other disposition required activities.
Manage CAPA records and may be required to function as a CAPA manager for minor or major CAPA as needed
Serve as QA Reviewer or impact assessor for downstream purification change control records.
Support and/or review various reports from quality systems and ensure quality mindset is strong
Own various standard operating procedures relating to Quality Operations processes such as Master Batch Record creation, Batch Record Review and Approval, New Product Introduction and Campaign Readiness and ensure the systems/processes are deployed effectively.

Requirements:

Excellent technical and regulatory understanding of the downstream drug substance purification processes.
Strong experience with various root cause analysis techniques such as 5-why, Kepner-Tregoe, force-field analysis, DMAIC, fault tree analysis.
Demonstrated capability of interpreting and adapting various technical reports in support of Investigations/Deviations.
Demonstrated capability of writing Investigation summaries in a concise and clear manner.
Strong understanding of industry regulations such as CFR, USP, EP, JP
On the floor Biologics experience in a GMP environment required
7+ years of leadership/management experience in an Operations, Manufacturing Technology or Technical Quality professional role.
BS/BA Degree (Biological or Chemical Science Preferred) and 9+ years of relevant experience or Masters Degree (Biological or Chemical Science) and 8+ years of relevant experience
Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment. #LI-CS1 #LI-Onsite

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.

See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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.