Sr Quality Lead Brazil

Ucb; São Paulo; Presencial; BRL 200.000 - 250.000; Tempo integral

Resumo da oferta

A global pharmaceutical company in São Paulo is looking for a Quality Manager to oversee the Quality Management System and ensure compliance with regulatory standards. This role involves managing audits, leading a team, and collaborating with various stakeholders to maintain high-quality standards in pharmaceutical production. The ideal candidate will have a degree in Life Sciences and substantial experience in quality management. Join us to help make a difference for patients.

Qualificações

• Proven experience in Quality Management Systems.
• Knowledge of cGxP and local regulatory requirements.
• Ability to lead and develop a team.

Responsabilidades

• Ensure effective Quality Management System implementation.
• Conduct audits and oversee corrective actions.
• Manage Quality Control processes and documentation.

Conhecimentos

Quality Management System implementation

Regulatory compliance

Team leadership

Risk management

Communication

Formação académica

Degree in Life Sciences or related field

Descrição da oferta de emprego

At UCB, we put our heart, soul, and skills into making a difference for people living with severe diseases.

Working together to push boundaries, we combine the best of our talents to unlock innovation.

Will you join us on our pioneering journey?

To strengthen our team, we are looking to fill the position of Quality Manager Brazil.

Key Responsibilities

• Facilitate, implement and maintain an effective and compliant Quality Management System in line with the Market Quality strategy and according to UCB policies, corporate quality standards, global SOP’s, cGxP and applicable local regulatory requirements.
• Address any deficiencies identified through audits or other means, providing guidance for identification and timely implementation of appropriate corrective and preventive actions.
• Ensure the execution and oversight of the local Quality Management System, including management of complaints, deviations, change controls and CAPA according to UCB corporate SOPs and using the relevant UCB electronic systems; including oversight of KPIs.
• Execute the periodic Management Review to assure consistency and compliance with UCB procedures and local regulations, and to ensure escalation to management of potential issues.
• Conduct the periodic Product Quality Review in accordance with the MAH responsibility.
• Provide quality oversight of local GxP Vendors in compliance with UCB Quality Standards and ENG guidance (qualification, agreements, vendor management, divestment).
• Approve any subcontracted activities impacting GDP or GMP at the affiliate.
• Establish and adhere to self‑inspection and external audit plans.
• Lead local recalls and all related correspondence with national competent authorities.
>Ensure all quality deliverables are completed in a timely manner in accordance with Global SOPs (e.g., follow up and closure on all relevant complaints, deviations and CAPAs, change controls).
• Support Market Quality in defining the appropriate organization of the area according to UCB strategic plans, identifying the right talents and appropriate resources to achieve quality compliance in line with UCB’s vision and strategy.
• Develop the skills, capabilities and expertise of the talents in the team across the area.
• Define and document roles and responsibilities for the area, through job descriptions, inter‑country agreements and In‑Market Quality procedures, as appropriate.
• Ensure efficient information flow and effective communication of relevant quality matters within the relevant Affiliate organization, from Territory to the Global QA organization and vice‑versa, including but not limited to issue escalation and communication of new regulations via the Regulatory Intelligence Network (RIN).
• Ensure the establishment of a business continuity plan for Quality activities.
• Represent the area in Market Quality meetings, Market Quality and Global Quality projects and improvement initiatives, as requested.
• Actively engage in the Affiliate Risk to Value process, collaborate with GxP and business stakeholders to identify and assess risks, and support the local risk champion in risk mitigation activities.
• Ensure compliance to GDP 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 readiness for all cGxP internal, external and regulatory inspections.
• Ensure training is timely performed and documented for Local Quality organization.
• Maintain the Site Master File and/or Quality Manual, as required.
• Ensure that the Intra‑group quality agreement with Global QA and associated appendices are complete and up to date.
• Ensure appropriate systems are in place at the Affiliate to ensure traceability of all products.
• Keep records of any delegated GDP or GMP duties at the affiliate needed.
• Ensure compliant final disposition of returned, rejected, recalled or falsified products and authorization of return to saleable stock of any returned medicinal products.
• Ensure any additional requirements imposed on controlled or un‑licensed medicinal products by national law are adhered to.
• Maintain competence in GDP and GMP through regular training.
• Ensure the analysis is carried out in Quality Control and in third parties in a timely manner according to applicable UCB standards and procedures, GMP and applicable local regulatory requirements.
• Ensure the facilities and the equipment of the Quality Control laboratory are properly maintained according to applicable UCB standards and procedures, GMP and applicable local regulatory requirements.

Pharmaceutical Responsible

Pharmaceutical Responsible:

Act as the Pharmaceutical Responsible for UCB Brazil and CRF according to current GMP / GDP guidelines, local laws.