Ultragenyx Pharmaceutical

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 Executive Director, Quality Assurance (Operations) will be responsible for Quality Assurance activities related to Drug Substance manufacturing operations at the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA. This role will provide leadership and oversight of a team that supports the core Manufacturing activities for Drug Substance across multiple shifts. Core activities include the review and approval of manufacturing records, deviation management, change record management, and support of batch disposition activities. This role partners closely with the Manufacturing leadership team, the downstream Drug Product Quality Assurance team, and cross-functionally with Engineering, Validation, QC, Quality Systems, and MSAT functions to ensure GMP product is made in a compliant manner, with a quality mindset, while maintaining a constant state of inspection readiness. This role is responsible for quality decisions related to Drug Substance manufacturing operations, material/product movement, and multi-product controls at the site. This role will also manage the performance and development of direct reports to ensure achievement of organizational and department goals within a product and effective environment.

ultrainnovative – Tackle rare and dynamic challenges

Work Model:

Core Lab & Ops: This 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:

• Lead the Drug Substance QA operations team to create, deploy and manage processes that ensure product quality during manufacturing operations and compliance with applicable FDA/EMA/applicable global health authority requirements and expectations. This is demonstrated through:
  • SOPs/Document Management: Approve all instruction sets, specifications, sampling instructions, and other procedures directly related to operations and other cGMP activities
  • Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
  • Raw Material Release: Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product
  • Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations
  • Validation/Maintenance: Ensure appropriate maintenance and a state of qualification is maintained for equipment and facilities in area of responsibility.
• Oversee the review and approval of GxP documents, including protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs, and other Quality Management System (QMS) documentation.
• Ensure the appropriate capabilities; procedures and quality mindset are in place to ensure GMP with a focus on data integrity / analysis and management
• Develop and maintain Key Quality Performance Indicators for site Quality operations and design and implement remediation strategies for out of tolerance metrics
• Set team objectives in alignment with business objectives and ensure that targets are managed.
• Manage and administer all aspects of people processes related to the employee life cycle.
• Coach and develop staff by providing an environment that encourages ongoing personal and professional growth. Manage and ensure the setting of realistic personal goals for 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 scientific field, preferably microbiology, chemistry or biochemistry.
• 15+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries with Manufacturing and Quality roles. 10+ years of Quality leadership/management experience
• Direct experience working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site. Knowledge and experience with drug substance, aseptic processing, and packaging.
• Strong 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
• Able to interface well with all levels of personnel, including peers and other department heads such as: Regulatory, Technical Operations, MSAT, Clinical Operations, Supply Chain and Project / Program Management.
• Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with manufacturing operations on product related investigations and deviations.
• Excellent communications skills, both written and verbal.
• Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
• 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%. Ability to travel to other Boston-area locations for larger team meetings

Physical Demand Requirements

General Manufacturing: Drug Substance/Central Svcs:

• Stand for extended periods of time with periodic stooping / bending / kneeling
• Able to lift, push, pull up to 50lbs.
• Climb ladders and stairs of various heights.
• 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.
• Certain tasks may require the use of a respirator; medical clearance will be required in advance.
• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment.
• Working in temperature-controlled environments (cold rooms).

#LI-CK1 #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

$267,200—$330,000 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.