Market Quality Lead U.S.

UCB•Atlanta, GA

22h•$148,000 - $194,300•Hybrid

About The Position

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. This is a hybrid role, requiring at least 40% of the time in the office.

Requirements

10+ years’ Quality Assurance experience within regulated pharmaceutical environment.
Bachelor's Degree in Biology, Chemistry, or other related scientific field.

Nice To Haves

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.

Responsibilities

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.