Market Quality Lead U.S.

Make your mark for patients

We are looking for a Market Quality Lead US who is highly visible, trusted, and dependable leader to join us in our Market Quality team, based in our Atlanta, GA office. This hybrid role (at least 40% of the time in office).

About the Role

The Market Quality Lead for an area or country is a local, transversal role designed to lead by example in fostering a culture of accountability, quality excellence, and continuous improvements, emphasizing oversight to implementation and compliance to UCB quality standards, policies, procedures, including compliance of cGxP regulation(s) imposed on controlled or un-licensed medicinal products by national laws or applicable regulatory authorities.

Who you’ll work with

Work with stakeholders (e.g., Affiliate Management, Market Quality, Global Quality, Supply Chain, Pharmacovigilance, Regulatory) organizations to facilitate support for the local Quality organization and ensure GxP operations deliverables are achieved in a timely manner.

What you’ll do

• Own and drive the performance, effectiveness, and continuous improvement of the local Quality Management Systems by ensuring all applicable Quality deliverables are consistently and effectively monitored, managed and completed in a timely manner and in accordance with Global SOPs.

• Address any deficiencies identified through audits and inspections by providing guidance for identification and timely implementation of appropriate corrective and preventive actions.

• Maintain the Site Master File and/or Quality Manual, as required.

• Execution of Management Reviews to confirm consistency and compliance with UCB procedures and local regulations, and to highlight adverse trends to management.

• Periodic Product Quality Review in accordance with the MAH responsibility

• Establish and adhere to internal self-inspection and audit programs

• Serve as primary representative during Health Authorities inspections.

• Ensure readiness and participation for all applicable cGxP external audits and regulatory inspections of UCB.

• Quality oversight to Local GxP Vendors in compliance with UCB Quality procedures, including qualification, quality agreements, monitoring through audit and/or periodic assessment, and divestment or discontinuation. Approving any subcontracted activities impacting GDP or GMP at the Affiliate. As applicable, ensure suppliers and customers of the Affiliate are qualified.

• Actively engage in the Affiliate Risk to Value process, collaborate with key GxP and business stakeholders to identify and assess GxP risks, and support the local risk champion in risk mitigation activities. Together with site management provide direction, formulate strategies and make decisions which ensure efficient Quality operations and Quality risk mitigation.

• Ensure product traceability as required. Implement compliant batch management and disposition processes including management of returned, rejected, recalled or falsified products and authorization of return to saleable stock for any returned medicinal products.

• Lead local recalls and all related correspondence with health authorities and assist in Global recall activities when required.

• Ensure compliance with GMP/GDP (GMP as applicable for Affiliates having GMP activities/license) and ensure proper shipping conditions are implemented for secondary and tertiary distribution, as applicable, driving a QA decision on the disposition of the product in case of deviations (including excursions).

• Ensure that within their Affiliate area a local GxP training program is established, documented, is compliant with training management KPI targets, and its effectiveness is periodically checked, and when applicable continuous learning for the purpose of career growth, qualification, or regulatory requirement is implemented.

• Define and document roles and responsibilities and delegated GMP or GDP activities where applicable (e.g., job descriptions, quality agreements, Market Quality procedures).

• Ensure information and documentation are maintained following applicable procedures and is stored in the appropriate UCB tool/system, and that appropriate local archiving system is in place.

• Communicate relevant quality matters within the relevant Affiliate organization, and with UCB stakeholders, including but not limited to quality issue escalation and regulatory intelligence, via the Regulatory Intelligence Network (RIN).

• Ensure compliance with applicable GMP/GDP UCB Business Continuity plans.

• Provide subject matter expertise and represent department interests in meetings, projects, committees, and improvement initiatives, as requested.

• Ensure compliance to applicable data integrity standards and procedures.

Interested? For this role we’re looking for the following

Minimum Requirements

• 10+ years’ Quality Assurance experience within regulated pharmaceutical environment.  Consumer Healthcare or Pharma industry preferred requirements.

• Bachelor's Degree in Biology, Chemistry, or other related scientific field.

Preferred requirements

• Strong knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) regulatory compliance, including experience hosting regulatory audits and inspections.

• Should be a self-motivated reliable leader and team player that is able to work autonomously, exercise good judgement, using a quality mindset, ability to handle complex/difficult situations, foster an attitude of collaboration, and ability to act as a role model for others in driving the company vision, incorporating strong ethical and patient focused principles.

• Experience operating in a multi-cultural and locational environment. Must be able to regularly and effectively interact and communicate (verbally and written) with internal and external stakeholders Ability to communicate both verbally and in writing using the local country language, and English is preferred.

• Experience in people management, including oversight to day-to-day responsibilities, performance monitoring, and providing guidance on career growth and development.

• Experience in developing effective solutions that foster process and business improvement.

• Experience in project management, quality auditing, risk management, and data analytics is preferred.

• Experience using key computerized systems (e.g., SAP, Veeva, Microsoft applications).

• Ability to travel when required.

*This position's reasonably anticipated base salary range is $148,000 - $194,300 annually. The actual salary offered will take into account internal equity and may also vary depending on the candidate’s geographic region, job-related knowledge, skills and experience, among other

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 over 9.000 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.

At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

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.