Head of External Quality North America

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

Lead and manage the North America (NA) QA functional area, reporting to the Head of External Quality within Global Quality. QA NA is accountable for GMP compliance across Sobi´s external Contract Manufacturing Organization (CMO) network within North America through robust quality oversight including Quality Operations for commercial products. QA NA is also responsible for ensuring optimal efficacy by embracing operational excellence and fostering a culture of continuous improvement by proactively identify and navigate the opportunities and risks inherent in the lifecycle of Sobi products.  QA North America is responsible for maintaining Sobi products are manufactured adherence to GMP standards in NA. 

The selected candidate will be expected to work onsite at our Morrisville, NC office two days per week as part of a hybrid work schedule. During the onboarding period, the candidate will be expected to be onsite three days per week to ensure a smooth and effective transition into the role.

• Lead and manage QAs in NA consisting of External Quality Operation managers
• Responsible for assigning and monitoring appropriate assignment and workload to the direct reports
• Responsible for a robust and proactive Quality oversight of CMOs in the region ensuring adherence to all relevant GMP regulations and effective agreements
• Responsible for the implementation and maintenance of quality risk assessment (identify, mitigate, manage and communication of risks) and Quality KPIs of CMOs
• Ensuring QA release of products within area of responsibility in timely manner
• Responsible for ensuring timely execution and completion of Quality Operations tasks related to the External network e.g. investigation and approval of Deviations, Complaints, approval of Change control, validation and QTA
• Support the direct reports for his/her activities at CMO such as GMP inspections, Technical Transfers and other projects where QA is presented
• Support GMP inspections from authorities, when needed
• Ensure appropriate QA resource utilization to meet supply and demand aligned with internal and external stakeholders
• Driving, coordinate and harmonize QA activities within the department and cross-functionally. Improve cycle time & efficiency for key quality processes
• Ensure effective communication of updates and impact both within own organization, cross-functionally and internal business stakeholders, respectively
• Responsible for the development and management of the functions and people in accordance with the mission, visions, values, and strategic business goals
• Implement efficiency improvements, quality development and cost-consciousness in the area of responsibility
• Actively participate in developing and regular follow-up on the Global Quality External Operation strategic planning initiatives
• Providing input and being responsible for Global Quality/Global QA External Operations strategic initiatives
• Lead the design, implementation and development of a proactive Quality organization with competencies to ensure reliable development, manufacturing and supply of competitive products and processes
• Prepare and monitor the budget including resources and maintain adherence to the approved plans

Qualifications

• Bachelor’s degree in pharmacy or other relevant degree (Engineering, Life science or alike)
• Minimum 15 years' experience from pharmaceutical industry within quality, manufacturing, product development and/or regulatory affairs
• Minimum 3 years of line manager experience with proven strong people leadership
• Pharmaceutical and business understanding including in-depth knowledge about regulatory and