Associate Director, Quality Assurance Operations

Position Summary

The Associate 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. The role will provide on‑floor oversight of drug substance manufacturing activities, including guidance during unexpected events, batch record review, room clearance, deviation and change control management, and drug substance disposition support. You will partner with Manufacturing, Facilities, MSAT, Validation, and Quality Control to support manufacturing and product release activities or ongoing projects/initiatives, ensuring compliant manufacture of GMP material (clinical or commercial). Operational excellence initiatives must be supported and driven from this level. The position requires independent work with limited supervision and includes quality decisions related to drug substance manufacturing operations, material/product movement, and multi‑product controls at the site, as well as managing the performance and development of direct reports.

Work Model

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

Responsibilities

• Provide on‑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 a quality mindset is strong.
• Own various quality procedures and ensure the systems/processes are deployed effectively.

Requirements

• Excellent technical and regulatory understanding of drug substance processes.
• Deviation/CAPA management experience; strong knowledge of root‑cause analysis techniques such as 5‑why, Kepner‑Tregoe, force‑field analysis, DMAIC, fault tree analysis.
• Ability to work independently without direct supervision or guidance and adapt to changing priorities.
• Strong understanding of industry regulations such as CFR and USP.
• On‑floor biologics experience in a GMP environment required.
• Demonstrates strong quality judgement in various situations when making decisions.
• 7+ years of leadership/management experience in an operations, manufacturing technology, or technical quality professional role.
• BS/BA degree in Biological or Chemical Science (preferred) with 9+ relevant years of experience, or a master’s degree in Biological or Chemical Science with 8+ relevant years of experience.

Physical Demand Requirements

• Stand for extended periods of time with periodic stooping, bending, or kneeling.
• Able to lift, push, or pull up to 50 lbs.
• Climb ladders and stairs of various heights.
• Work in a controlled GxP environment requiring gowning and protective clothing on the head, face, hands, feet, and body. This includes changing 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 makeup, jewelry, and contact lenses while in the manufacturing environment.
• Work in temperature‑controlled environments (cold rooms).

Salary and Benefits

Pay range: $184,000 USD – $227,300 USD. This position is eligible for annual bonus and equity incentives; actual pay is determined by demonstrated experience and internal equity alignment.

• 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 sponsorship.
• Professional development plans.
• Benefits vary by region and country.

EEO Statement

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

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.

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