What are the responsibilities and job description for the Head of Market Quality US position at UCB?
Make your mark for patients
UCB is seeking a Head of Market Quality, US to join our Global Quality team. The ideal candidate will be energetic, committed to continuous improvement, and possess clear communication skills. The position is based in Atlanta, GA.
About the role:
This key leadership role involves overseeing Quality operations for our commercial affiliate in the United States, ensuring strong guidance and support. The primary objectives of this role are to seamlessly integrate quality practices at commercial affiliate, ensuring compliance with local and international regulatory requirements across UCB, and providing insight and guidance to the various UCB stakeholders on the US requirements related to quality operations at commercial affiliate. This position also entails responsibility for staff and talent management, including performance management and professional development.
Who you’ll work with:
The Head of Market Quality, US, reports to the Head of Distribution and Market Quality and works in strong collaboration with the Market QA Heads of the other regions (Europe and Intercontinental) to ensure consistency of quality operations within the commercial affiliate network. He/she will also partner with peers and internal stakeholders at global and regional level (e.g., other Quality Units, Global Supply Chain, Regulatory Affairs, Pharmacovigilance, etc.).
What you’ll do:
- Articulate the goals and expectations for your team to secure, establish, optimize and elevate Affiliate Quality operations
- Ensure the right talents are in place and appropriate resources allocated to achieve quality compliance in-line with UCBs vision and values, stimulating the integration and collaboration between the territories.
- Oversee the local Quality organization to deliver best in class service and ensure implementation, maintenance and continuous improvement of the local Quality System in order to drive compliance of all relevant cGxP with local/International regulatory requirements and UCB global standard operating procedures
- Ensure quality governance and quality planning in the Territories through the establishment and implementation of appropriate Key Quality Indicators, Quality Risk Management Assessments and execution of periodic Management Review of Quality Systems. Ensure Affiliate readiness for all GxP regulatory inspections.
- Serve as the primary Regional Affiliate Quality contact and collaborate with local operations and management to ensure that processes are aligned with prevailing international requirements.
- Keep current on all-pertinent regulatory publications, international regulations, guidelines and requirements, identify shortcomings and initiate working groups to implement changes following the gap analyses, in line with the RIN global process
- Connect internal and external stakeholders (eg. QA, Patient Supply, Regulatory, Safety etc.) with Local Quality organizations to facilitate a holistic approach of GxP regulatory compliance
- Ensure quality oversight and direction to local vendors and partners and ensure that they are qualified (including audits and quality agreement) to perform their activities in compliance with UCB Quality Standards.
Interested? For this role we’re looking for the following education, experience, and skills:
Basic Qualifications
- Master’s Degree in Scientific and/or Pharmaceutical field and/or Engineering
- 10 years leadership experience in the Biopharmaceutical industry within regulated areas (e.g., Manufacturing, Distribution) and/or Quality Assurance expertise
- In depth knowledge and understanding of the complexity of the BioPharma business and GXP principles, including the interpretation and practical application of applicable regulations.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
