Sr Quality Lead Brazil

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 mean
providing guidance for identification and timely implementation
appropriate corrective and preventive actions.
- Ensuring the execution, and having the oversight, of the local Quality
Management System, e.g.
- Management of complaints, deviations, change controls and CAPA
according to UCB corporate SOPs and using the relevant UCB
electronic systems; including oversight of KPIs
- Execution of the periodic Management Review to assure
consistency and compliance with UCB procedures and local
regulations, and to ensure escalation to management of (potential)
issues;
- Periodic Product Quality Review in accordance with the MAH
responsibility;
- Quality oversight to Local GxP Vendors in compliance with UCB
Quality Standards and ENG guidance (qualification, quali
agreements, vendor management, divestment).
Approving any
subcontracted activities impacting GDP or GMP at the affiliat
- 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 ar
according to UCB strategic plans, identify the right talents and appropriate
resources to achieve quality compliance in line with UCBs vision and
strategy.
Develop the skills, capabilities and expertise of the talents in the
team across the area.
Define and document roles and responsibilities f
the area, through job descriptions, inter-country agreements, In-Market
Quality procedures, as appropriate.
- Ensure efficient information flow and effective communication of
relevant quality matters within the relevant Affiliate organization, from t
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 k
GxP and business stakeholders to identify and assess 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 mitigatio
- 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 in place at the Affiliate to ensure produ
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 falsi
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 is
properly maintained according to applicable UCB standards and
procedures, GMP and applicable local regulatory requirements.
Pharmaceutical Responsible:
Act as the Pharmaceutical Responsible for UCB Brazil and CRF according to
current GMP/GDP guidelines, local laws