Patricia Miranda Brucker

Berufserfahrung von Patricia Miranda Brucker

• Bis heute 2 Jahre und 11 Monate, seit Juli 2021

  Senior Director Global Quality Management

  immatics biotechnologies GmbH

• 1 Jahr und 2 Monate, Mai 2020 - Juni 2021

  Director Global Quality Management

  immatics biotechnologies GmbH

  Immatics is a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting immunotherapies for the treatment of cancer. Immatics transformative product candidates are - best in class - Adoptive Cell Therapies and Bispecific TCR molecules. These products are directed against tumor targets that have been identified and validated by Immatics'​ proprietary and world-leading XPRESIDENT® technology. http://www.immatics.com

• 6 Monate, Juli 2019 - Dez. 2019

  Chief People Officer

  Eurofins BioPharma Product Testing Munich

  • Support recruitment of group leaders, scientists and analysts. • Individual leadership coaching of key scientists in the bioassay department. • Creation and present plan for site’s staff development and retention. • Lead projects for improvement of laboratory operations, including planning process and onboarding training for the bioassay department. • Single point of contact for some clients regarding operations matters in the bioassay department.

• 6 Monate, Jan. 2019 - Juni 2019

  Senior CQA Manager DACH

  Baxter Deutschland GmbH

  Lead Quality Assurance function for Germany, Austria and Switzerland • Lead country/regional teams reporting to the position. Manage department budget • Maintain and optimize the Quality Management System, ensuring compliance with GMP, GDP, ISO 9001 and ISO 13485 • Responsible for Post Market Surveillance • Provide advice to business in quality related matters • Host inspections by regulatory agencies • Lead Quality Management Review process for the site

• 1 Jahr und 8 Monate, Apr. 2017 - Nov. 2018

  Head of Quality Assurance

  Eurofins BioPharma Product Testing Munich

  Head of Quality Assurance department (GMP, GLP, GCP and ISO 17025) at Eurofins BioPharma Product Testing Munich, a first-class CRO, working with pharmaceutical, chemical, biotechnology, medical device and cosmetic clients covering the whole chain of drug development. With over 30,000 employees, Eurofins is a leading international group of laboratories providing a unique range of analytical testing services to the pharmaceutical, food, environmental and consumer products industries and to governments.

• 5 Monate, Nov. 2016 - März 2017

  Head of Quality Assurance GMP

  Eurofins BioPharma Product Testing Munich

  Head of the Quality Assurance GMP department at Eurofins Pharma Product Testing Munich GmbH.

• 1 Jahr und 6 Monate, Jan. 2015 - Juni 2016

  Regional Quality and Compliance Officer

  Boehringer Ingelheim Bv

  Lead Quality Assurance and Compliance functions for the MIDI region, including Netherlands, Belgium, Denmark, Sweden, Finland, Norway, Portugal and Greece. Responsible for setting and driving Quality and Compliance strategy for the region. Developed and implemented Quality Management System for the region. Member of GMP Corporate Auditors group. Solid experience in staff management and project management.

• 5 Jahre und 6 Monate, Juli 2009 - Dez. 2014

  Safety, Quality and Environmental Protection Manager

  Boehringer Ingelheim Pty Limited

  Lead Quality Assurance, Legal Compliance and Workplace Safety functions for Australia and New Zealand. Developed and implemented QMS, obtaining certification from the regulatory authorities in Australia. AP for human and veterinarian products. Member of GMP Corporate Auditors group. Implemented legal Compliance Framework for 7 compliance areas incl. Healthcare Compliance, Privacy, etc. Responsible for management of Workplace Safety Management System. Solid experience in staff and project management.

• 1 Jahr und 1 Monat, Juni 2008 - Juni 2009

  Compliance Officer

  Boehringer Ingelheim Pty Limited

  Establishment of crisis management policies and business continuity plans. Performance of OHS audits, workplace inspections and risk assessments and implementation of CAPAs. Accident management and investigation. Management of workers compensation cases. Management of project for implementation of Records Management and Retention Program.

• 2 Jahre und 11 Monate, Juli 2005 - Mai 2008

  Technical Associate Quality Control

  Boehringer Ingelheim Pharma GmbH & Co KG

  Responsible for creation of testing specifications for packaging materials and medical devices in accordance to regulatory requirements from health authorities around the world. Active participation in audits from regulatory authorities including EMA, Anvisa and supplier audits. Preparation of submission documents and implementation of regulatory requirements from health authorities. Creation and implementation of Change Control requests.

• 3 Monate, Aug. 2004 - Okt. 2004

  Quality Assurance Supervisor

  Boehringer Ingelheim do Brasil Quimica e Farmaceutica Ltda

  Management and investigation of customer complaints. Management and investigation of product recalls. Preparation and evaluation of product quality review reports.

• 1 Jahr, Aug. 2003 - Juli 2004

  Compliance Officer

  Boehringer Ingelheim Pharma GmbH & Co KG

  Active participation in audits from regulatory authorities including EMA, FDA, Anvisa and suppliers. Responsible for investigations of deviations, OOS and product technical complaints related to all stages of manufacturing and packaging of bulk and drug products. Responsible for CAPA implementation.

• 2 Jahre und 1 Monat, Juli 2001 - Juli 2003

  Production and Packaging Supervisor

  Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda

  Management of a team of approximately 100 employees. Management of manufacturing processes including granulation, compression, coating and packaging of solids and manufacturing and packaging of liquids and aerosols. Planning and management of production and packaging activities. Optimization of production and packaging processes. Participation in audits from regulatory authorities including EMA and Anvisa.

• 1 Jahr und 7 Monate, Dez. 1999 - Juni 2001

  Production and Packaging Analyst

  Boehringer Ingelheim do Brasil Quimica e Farmaceutica Ltda

  Management of cleaning and process validation - development of validation plans, protocols, and reports, and performance of tests. Management of equipment qualification and computer systems validation - development of qualification and validation protocols and reports, and performance of tests. Responsible for development, qualification and implementation of dispensing system for production. Preparation and participation in self-inspections.

• 1 Jahr und 5 Monate, Juli 1998 - Nov. 1999

  Final Batch Release Analyst

  Boehringer Ingelheim do Brasil Quimica e Farmaceutica Ltda

  Review of manufacturing, packaging and quality control documentation for final batch release. Investigation of deviations related to batch release and implementation of CAPAs.

• 1 Jahr und 1 Monat, Juli 1997 - Juli 1998

  Project Manager

  Pharma Junior Consulting - University of Sao Paulo

  Project management in areas of manufacturing of pharmaceutical and food products.

• 8 Monate, Nov. 1997 - Juni 1998

  Quality Assurance Trainee

  Boehringer Ingelheim do Brasil Quimica e Farmaceutica Ltda

  Responsible for review of in-process control strategies for packaging. Development of deviation system. Delivering of face-to-face training for production and quality operations staff: GMP, related systems and quality documentation. Implementation of a manual of pharmaceutical defects evaluation for packaging of solids and liquids.

• 1 Jahr und 6 Monate, Dez. 1996 - Mai 1998

  Trainee in microbiology

  University of Sao Paulo

  Participation in scientific projects involving gene therapy using viral vectors.

• 1 Jahr und 1 Monat, Dez. 1995 - Dez. 1996

  Trainee in enzyme purification

  University of Sao Paulo

  Participation in scientific projects related to enzyme purification.