Head Of Qa North America

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Head of QA North America

Role & Function

The Head of QA Regions is accountable for Quality Assurance oversight at the regional level. He / she is a member of the Global Quality Leadership team and is responsible to ensure the region, including its suppliers and local affiliates operate in adherence to all relevant regulations, cross-functional business endeavours, as well as the Sobi policies, procedures, and effective agreements.

Key Responsibilities

• Responsible for the development and management of the functions and people in accordance with the mission, visions, values, and strategic business goals.
• Responsible for the oversight and coordination of QA activities of Sobi affiliates
• Work with the cross functional business teams to identify the Quality requirements based on the supply chain and proposed business flow.
• Responsible for SHE in own area
• Responsible for regional new regulations requirements surveillance and implementation in his/her area of responsibilities
• Identify and lead the required QA activities in the respective markets as per the business plan
• Serve as Quality Assurance leadership in Business Review Meetings
• Establish and maintain the quality process and procedures in the region in accordance with applicable laws, regulations, and in compliance with Sobi global procedures, and respective quality agreements.
• Implement efficiency improvements, quality development and cost-consciousness in the area of responsibility.
• Lead a team of Quality Supplier Managers. He/she will also dynamize QA Affiliates
• Author and implement Quality Agreements with the external suppliers and/or Affiliates, as needed
• Manage the Quality assurance activities within the region and communicate updates and impact cross-functionally to the Head of Quality, and internal business stakeholders, respectively.
• Responsible for supplier qualification in the region, including the initial approval and onboarding, routine oversight/maintenance, and escalation of risk and/or termination.
• Prepare the budget including resources and maintain its adherence the approved plans.
• Establish and maintain proactive QA oversight of supplier activities within the region, including but not limited to product manufacturing and distribution
• Lead the Quality aspects for Due Diligences activities.
• Responsible for the implementation and maintenance of quality risk assessment and Quality KPIs of suppliers
• Actively participate in developing and regular follow-up on the Global Quality strategic planning initiatives

Qualifications

• More than 10 years of experience in pharmaceutical and biotech products. Experience in QA operation, production in development and commercial environment
• Strong proven leadership ability to manage challenging decisions in a logical and compliance manner
• Fluently spoken and written English
• Proven interaction with high impact stakeholders
• Minimum 10 years in Leadership Experience
• High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
• Experience in strategic planning and organizational effectiveness
• Proven track record with U.S FDA, EMEA or other Health Authorities

Personal attributes

• Abilities to develop teams to achieve excellence
• Culture awareness and understanding the way of behaviors in different cultures
• Result oriented -Efficient communication with senior management, key stakeholders and strategic business partners.
• Holistic business understanding In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
• GCP and GVP understanding desired
• Interpersonal, leadership and decision-making skills to operate in a complex cross-functional environment.'
• Comfortable in a global and complex environment.
• Abilities to handle conflicts
• Strong understanding of the GMP & GDP requirements

Location

The position will be based in Durham, United States.

Reporting to

Vice President, Head of Global Quality

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]
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.
If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application.
Why Join Us?
We are a global company with around 1,500 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.
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