Summary
Overview
Work History
Education
Skills
Languages
Personal Information
Timeline
Generic
TANIA VALERA CERQUEIRA

TANIA VALERA CERQUEIRA

Vienna

Summary

Results-driven professional with a strategic mindset and hands-on approach, offering extensive experience in management roles focused on Quality, HSE, and Operational Excellence. Expertise includes highly regulated and complex environments such as Chemicals, Pharma, Medical Devices, and Fertilizers, along with specialized sectors like Automotive, Polyolefins, and Plastics. Proven ability to lead teams in achieving compliance and operational efficiency while fostering a culture of continuous improvement. Committed to driving organizational success through innovative solutions and effective leadership.

Overview

4
4
Languages
26
26
years of professional experience

Work History

HEAD OF GLOBAL QUALITY

Borouge International/Borealis GmbH
Austria
12.2022 - Current
  • Multiple global sites oversight of Polyolefins/Base Chemicals/ Energy/Wire & Cable/ Consumer Products/ Automotive/Pharma
  • Successfully driving QHSE Integrated Management System, multi site matrix Certifications maintenance, optimizing costs and ensuring harmonization of processes globally. Reducing to zero findings in Third Parties Audits in two years.
  • Support to Regulatory Compliance, ensuring 100% readiness to market in NPI.
  • Enhancing performance of Complaint Management, systematic promoting higher NPS (Net Promoting Score), supporting the company´s strategy.
  • Driving Digital Transformation of the Governance & Document Management System thru comprehensive Global BPM Project, reducing complexity and associated costs of the management system administration - simplify to excel.
  • Suppliers Management - Establishing SQM with risk based approach, supporting the reduction of associated costs for supply sources qualification without jeopardizing quality assurance metrics performance.
  • Self-motivated, with a strong sense of personal responsibility.
  • Used critical thinking to break down problems, evaluate solutions, and make decisions.
  • Proven ability to learn quickly and adapt to new situations.

EMEA REGIONAL QUALITY OPERATIONS LEADER

Corteva
Switzerland
10.2021 - 12.2022
  • EMEA regional scope (one year assignment)
  • Fertilizers/Seeds/ Technologies for Agribusiness
  • Ensuring QMS ISO Certifications successfully with no major non conformities, driving corrections and improvements in the management system processes and controls.
  • Established Onboarding Training Program for EMEA, improving teams awareness about Quality and Continuous Improvement
  • CMO - Defined and implemented Quality System Requirements for the Contract Manufacturers, improving overall CMO performance thru consistent monitoring and performance feedback.

VP GLOBAL QUALITY ASSURANCE & REGULATORY AFFAIRS

Pall Biotech
Danaher, Switzerland
01.2020 - 09.2021
  • Multiple global sites
  • Reactors/Filtration systems for Biotech/Pharma business
  • Quality Strategical & Tactical Plans – Regulatory Compliance – Audits – Training Management – New Products Introduction – Quality Risk Management
  • Led cross-functional teams through product development, commercialization, and operational planning.
  • Aligned commercial priorities with customer requirements for downstream processing applications.
  • Partnered with quality and manufacturing teams to support compliance and product consistency.
  • Collaborated with senior management to develop strategic initiatives and long term goals.

HEAD OF CORPORATE GLOBAL QUALITY MANAGEMENT SYSTEMS

Lonza AG
Switzerland
12.2016 - 01.2020
  • Oversight of Corporate Quality System of multiple global sites of CDMO/Pharma/APIs/ Drug Products/Medical Devices
  • Led the Global Quality Management System (E2E) across the different divisions worldwide (fulfilling the requirements of ICH Q10, CFR 21 Part 11, CFR 21 Part 820, ISO 9001, GxP, ISO 13485, FAMI QS, FSSCC 22000 etc.).
  • Responsible for global strategy and tactical plans / CAPA, Deviation, Validation, OOS, Document Global Supplier Quality Group - Global Data Owner and Administration of the Global Document Management System (eDMS).
  • Ensured inspection readiness – FDA, Swiss Medic, MHRA, ANVISA, etc, supporting successful outcomes with no major reported findings.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.

GROUP QUALITY MANAGER – NITRO FERTILIZERS / AMMONIA/UREA

Borealís AG
Austria
01.2013 - 12.2016
  • Directed quality management system compliance across production, documentation, and corrective action processes EMEA multiple european sites - Nitrogen/Ammonia/Urea Products for Agribusiness and Industrial applications
  • Led internal and external audits, ensuring readiness for ISO and customer requirements.
  • Integration Project to harmonize multi sites in Europe – Customer Complaint Management – Customer Service – Supplier Audits – Regulatory Requirements Compliance – ISO Certifications and general routine of QMS – Operational Excellence initiatives to improve productivity and reduce customer complaints related to product quality (mostly Ammonium Nitrate).
  • Coordinated supplier quality reviews, strengthening incoming inspection and material acceptance standards.
  • Monitored quality indicators, identifying process gaps and supporting continuous improvement initiatives.
  • Trained cross-functional teams on quality standards, escalation pathways, and compliance expectations.
  • Oversaw customer complaint investigations, resolving issues through structured containment and corrective actions.

QHSE PLANT MANAGER

Syngenta Crop Protection
Brazil
01.2010 - 01.2013
  • Directed plant operations Crop Protection Products / Herbicides/ Insecticides/Pesticides to align production, quality, and safety targets with crop protection requirements. Single site in Brazil / Global Project with HQ in Switzerland
  • Oversaw EHS compliance, supporting incident prevention, audit readiness, and regulatory adherence.
  • QA-QC-QMS-HSE-Risk Management routine / Operational Excellence Initiatives to improve productivity/thruput - Inspection Readiness for ANVISA, CETESB, etc/ ISO 9001, ISO 14001, OHSAS 18001 Certifications.
  • Implemented continuous improvement initiatives to reduce waste and strengthen operational reliability. Implementation of 5S and Housekeeping
  • Initiatives to reduce White-off products delivered cost savings of couple of million dollars.
  • Directed employees and related programs to maximize team productivity and facility output.

QHSE PLANT MANAGER

BASF
Brazil
01.2007 - 01.2010
  • Single site - Catalyst for Exhausting Systems – Automotive
  • HSEQ Management System Certifications and maintenance – Training Management – Occupational Health & Safety Operational Standards implementation – Risk Management – Improvement Projects using Six Sigma / Lean Manufacturing.
  • Operational Excellence Initiatives to reduce waste of precious metals in the slurry impregnation delivered significant cost avoidances and the project was recognized in global level, standardizing processes and controls in manufacturing parameters.
  • Led, trained and coached plant staff to facilitate high levels of productivity and quality.
  • Monitored and evaluated plant performance to identify areas for improvement and take corrective measures.
  • Maintained quality of product with robust inspections and assessment team.

QHSE SYSTEM MANAGER

Fosfertil
Brazil
01.2001 - 01.2007
  • Multiple sites in Brazil - Ultrafertil-Fosfertil (former Fertilizer Division PETROBRAS) of Mining Operations/ Monoammonium phosphate (MAP), diammonium phosphate (DAP), and triple superphosphate (TSP)/ Nitrogen & Chemical Products: Ammonia, Urea, Acid Nitric
  • HSEQ Management System Certifications and maintenance – Quality & HSE Training Management
  • Designed and implemented matrix Internal System Audits Program, improving resources allocation and promoting effective cross learnings
  • Implemented Supplier Qualification Process and established Supplier Performance Management, improving quality assurance requirements implementation.
  • Inspections Readiness for CETESB, ANVISA
  • Continuous Improvement Projects, based on Lean Manufacturing and Housekeeping practices delivered general improvements across the sites network.

Education

MBA - Business Administration /Organization Development

FGV
01.2007

MSc - Quality Engineering and Productivity

FEI - Engineering School
01.1997

Bachelor of Science - Natural Sciences & Chemistry

Fundacao Santo Andre/PUC SP
Sao Paulo-SP
01.1995

Skills

  • Certification of complex management systems
  • Proficient in ISO certifications
  • ICH Q10, CFR 21 Part 11, CFR 21 Part 820, GxP
  • Expertise in FAMI QS and FSSC 22000 standards
  • Responsible Care
  • ISO 27001 compliance
  • ISO 37001 and ISO 37301 implementation experience
  • Competence development oversight
  • Creation of strategic training frameworks for quality and safety standards
  • Development of training programs for front line leaders
  • Expert lecturer in quality and HSE topics
  • Audit and compliance oversight
  • Annual audit program management
  • Oversight of auditor training programs
  • EHS Regulations Training Programs for internal employees
  • Quality assurance in customer care
  • Assessment of customer feedback mechanisms
  • Product and service training for customer services
  • Business process management
  • Governance model redesign
  • Data governance and document oversight
  • Document management system design and implementation
  • CONTINUOUS IMPROVEMENT & OPERATIONAL EXCELLENCE
  • Lean Six Sigma Green Belt
  • Managing continuous improvement efforts using lean principles

Languages

Portuguese – native
Spanish – second language
English – business fluent
German / French – basic communication

Personal Information

Nationality: Brazilian-Spanish citizen

Timeline

HEAD OF GLOBAL QUALITY

Borouge International/Borealis GmbH
12.2022 - Current

EMEA REGIONAL QUALITY OPERATIONS LEADER

Corteva
10.2021 - 12.2022

VP GLOBAL QUALITY ASSURANCE & REGULATORY AFFAIRS

Pall Biotech
01.2020 - 09.2021

HEAD OF CORPORATE GLOBAL QUALITY MANAGEMENT SYSTEMS

Lonza AG
12.2016 - 01.2020

GROUP QUALITY MANAGER – NITRO FERTILIZERS / AMMONIA/UREA

Borealís AG
01.2013 - 12.2016

QHSE PLANT MANAGER

Syngenta Crop Protection
01.2010 - 01.2013

QHSE PLANT MANAGER

BASF
01.2007 - 01.2010

QHSE SYSTEM MANAGER

Fosfertil
01.2001 - 01.2007

MSc - Quality Engineering and Productivity

FEI - Engineering School

MBA - Business Administration /Organization Development

FGV

Bachelor of Science - Natural Sciences & Chemistry

Fundacao Santo Andre/PUC SP
TANIA VALERA CERQUEIRA