Associate Director, QA Supply Chain at Ultragenyx in Woburn, 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

We are seeking a highly motivated QA Supply Chain Associate Director with experience in both clinical and commercial packaging, labeling and distribution. The ideal candidate will have experience working with Contract Manufacturing Organizations (CMOs), good working knowledge of global GxPs supporting clinical and commercial packaging /labelling and distribution. The candidate will work closely with the Technical Operations Supply Chain team to independently manage aspects of our global clinical and commercial pack / label contractors and distribution centers. The candidate has a demonstrated ability to develop strategic plans for pack/label activities across clinical and commercial programs and to establish and maintain Quality Agreements, support deviations and CAPAs, manage complex changes, identify and mitigate inspection risks.

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:

Provide strategic planning/support for pack/label activities across clinical and commercial programs
Negotiate, implement, and manage quality agreements with pack/label and distribution contract organizations
Support review of clinical and commercial label text, label proofs, and label specifications
Support review of distribution protocols for Contract Distribution providers in accordance with SOPs
Prepare and support Quality Quarterly Business Review metrics for Supply Chain Contract Organizations
Help ensure quality of products produced / maintained at contractors through review and technical approval of batch production records, significant changes, related to the supply chain, and work with Technical Operations and CMOs to proposed solutions for recurring problems.
Perform assessments for change controls within electronic document management systems
Review and approve deviations and discrepancies at CMOs to assess product quality impact. Monitor effective checks of CAPAs.
Subject Matter Expert for packaging/labeling of clinical and commercial products. Includes knowledge of manufacturing operations, label artwork / printing and label review.
May function as Person-in-the-Plant (PIP) at CMO sites. This position may also assist in the auditing of contract pack / label sites and distribution centers.
Collaborate with business partners and GMP / GDP-regulated vendors to ensure successful planning, execution and delivery of projects.
Ensure activities and deliverables are in compliance with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx’ policies, SOP’s and best practices.
Support the Tech Ops team in Supply Chain risk assessment and Shipping Validation
Identify and drive improvements within the Supply Chain QA team

Requirements:

Provide strategic planning/support for pack/label activities across clinical and commercial programs
Negotiate, implement, and manage quality agreements with pack/label and distribution contract organizations
Support review of clinical and commercial label text, label proofs, and label specifications
Support review of distribution protocols for Contract Distribution providers in accordance with SOPs
Prepare and support Quality Quarterly Business Review metrics for Supply Chain Contract Organizations
Help ensure quality of products produced / maintained at contractors through review and technical approval of batch production records, significant changes, related to the supply chain, and work with Technical Operations and CMOs to proposed solutions for recurring problems.
Perform assessments for change controls within electronic document management systems
Review and approve deviations and discrepancies at CMOs to assess product quality impact. Monitor effective checks of CAPAs.
Subject Matter Expert for packaging/labeling of clinical and commercial products. Includes knowledge of manufacturing operations, label artwork / printing and label review.
May function as Person-in-the-Plant (PIP) at CMO sites. This position may also assist in the auditing of contract pack / label sites and distribution centers.
Collaborate with business partners and GMP / GDP-regulated vendors to ensure successful planning, execution and delivery of projects.
Ensure activities and deliverables are in compliance with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx’ policies, SOP’s and best practices.
Support the Tech Ops team in Supply Chain risk assessment and Shipping Validation
Identify and drive improvements within the Supply Chain QA team #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.

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.