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 QA External Operations 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, 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 GMP requirements
• Extensive experience in managing external GMP/GDP CMOs
• Experience from setting up and working with performance management, KPIs, including the management cycle
• Experience from working with improving business practices/working procedures
• Experienced in working with high impact stakeholders, e.g. authorities, strategic business partners.
• Experience from working in an international organization and across borders and with different cultures

Personal Attributes

• Strong in people leadership, proactiveness and communication
• Able to coach and develop people and the organization
• Strong interpersonal skills and collaboration skills
• Result oriented and able to solve complex situations and problems
• Able to handle conflicts and create win-win situations
• Culture awareness and understanding the way of behavior in different cultures
• Holistic business understanding
• Courage, empathy, trust, motivation
• Fluent in English

Additional Information

The base salary pay range for this role is $175k-$240k annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected]

COVID-19 Policy

For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.