Director, Quality Assurance Site GMP Compliance

This leadership role will drive efforts for establishing, assessing, and maintaining compliance to applicable cGMP requirements at both the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA and the Quality Control Laboratories located in Woburn, MA. This role is responsible for the execution of a robust site self-inspection program, enhancing learning and understanding of core cGMPs, and leading inspection readiness activities. This role will support internal audits and external health authority inspections and help provide intelligence for current regulatory trends.

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

Responsibilities:

• Own and execute the Site Self-inspection program to ensure it adequately assesses applicable areas to determine existing state cGMP compliance.
• Monitor GxP intelligence (health authorities, industry trade organizations, etc.) to identify compliance trends and incorporate them into existing programs.
• Develop and maintain Quality System metrics to measure inspection readiness. Proactively identify, escalate, and address negative trends.
• Develop and lead strategic efforts to constantly improve overall cGMP compliance.
• Lead the Quality Assurance Training team to ensure training activities drive the development and understanding of core cGMP concepts such as GDocP, Data Integrity, and Quality Mindset.
• Ensure the development of training curriculum to ensure consistency and effectiveness.
• Participate and/or host internal audits or health authority inspections at the site; facilitate the completion of responses and completion of applicable actions.
• Serve as a Compliance representative on cross-functional and multi-site teams and provide compliance interpretation of GxP for clinical and commercial operations.
• Work with the Global GxP Compliance Team teams to ensure consistency in approach and mindset for audits and inspections.
• Set team objectives in alignment with business objectives and ensure that targets are achieved.
• Develop and train personnel and internal / external customers on relevant business processes and GxP topics.
• Foster an environment of accountability, diversity and speaking up.
• Perform any other tasks as requested by management to support Quality oversight activities.

Requirements:

• Minimum of a Bachelors Degree in a science, engineering, or related technical discipline.
• 12+ years of experience in biopharmaceutical or biotechnology GMP operations with a majority of experience in commercial operations.
• 4+ years of direct supervisory experience of technical or quality professionals with demonstrated effectiveness to recruit, hire, and training and the ability to provide continued guidance, mentorship and support to staff.
• Strong organizational and project management skills with a track record of meeting goals/objectives.
• Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections.
• Proficiency with data analysis tools to identify trends.
• Excellent verbal and writing communications skills
• Excellent teamwork, interpersonal skills, influencing skills and negotiation skills.
• Travel may be required up to 10%. Most travel will be between Ultragenyx locations located in Boston or San Francisco areas.

Pay Range: $200,300 - $247,500 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.