I have strong experience at Pharmceuticals for all related quality , development and technical Operations aspects. I have spent all my career at Pharmaceutical companies providing deep GxP knwoledge. I have been exposed to all different regulators (FDA,EMA, Anvisa, Japan Authrorities etc) , having strong experience in dealing with warning letters and change management .

Group Quality operations @ Responsible for all the group quality operations across Novartis Quality organization, which has quality standards, quality systems , GxP training, Risk Management, Countries organization and Third party operations from quality point of view. From January 2013 to Present (2 years 10 months) Basel- SwitzerlandGroup Head of Quality Standards and Systems @ To define Group Quality standards and systmes applicable to all manufacturing and development sites across the Novartis organization. Also responsible to define and implement cGxP training strategy across the Quality and manufacturing organization From January 2010 to September 2013 (3 years 9 months) Group Head Quality Systems and Quality Control @ Responsible to define , execute and monitor the quality standards and systems across Novartis to anticipate regulatory and industry trends to drive continuous improvement.. Responsible to define the laboratories practices to ensure that the lab operations are in compliance, capable and competent. From January 2010 to September 2013 (3 years 9 months) Pharma Quality Control Head @ Responsible for the Quality Control laboratories across the division of Novartis Pharma ( 25 sites approx). During this period, laboratories practices were defined and roll out to ensure full compliance with the regulations and expectations as well as efficiency with the lab operations ( lean lab initiative and Analytical Science Technology organization set up) From June 2009 to June 2011 (2 years 1 month) Basel Area, SwitzerlandPharma Quality Control Head @ Responsible to define quality control strategy to ensure the laboratories are in compliance, competent and capable. It applies to all labs from manufacturing and technical development units From June 2009 to June 2011 (2 years 1 month) Site Quality Assurance Head @ Responsable final para la calidad y compliance de la fábrica de Novartis Pharma en España From January 2007 to June 2009 (2 years 6 months) New Products Launch Quality Head @ Responsible to define the quality control and assurance standards, systems , regulatory strategy for new products for Phase IIl until Pre Approval inspection . Commercialization launch. From May 2003 to December 2006 (3 years 8 months) North and South Europe Region Head @ Responsible to provide oversight to the sites from the North and South Europe Region. 5 sites FDA exposure and launch sites. My responsibility was to provide guidance , decision making on key product issues and implementation of corporate standards and initiatives. From October 1999 to June 2003 (3 years 9 months) Site Remediation program Manager @ Responsible for site remedidation plan with change management deployment. Experience on Warning Letters From January 1998 to September 1999 (1 year 9 months) UKQuality head/technical director - production site @ Ensure site is in compliance with all cGxP applicable requirements and promote quality cultrue across the site organization .Responsible for the the site quality control, quality assurance and compliance activities . Also I was acting as Production site head . From 1992 to 1998 (6 years)

Business management, Curso de desarrollo @ Cranfield School of Management From 1997 to 1998 Bachelor of Pharmacy (B.Pharm.), Industry Technology @ Universidad de Barcelona From 1986 to 1991 High School @ Sao VIcente From 1978 to 1986 high school @ Sao VIcente Montse Montaner is skilled in: GMP, Pharmaceutical Industry, Validation, CAPA, 21 CFR Part 11, FDA, GxP, Regulatory Affairs, Sop, Change Control, V&V, Computer System..., Quality System, GLP, Aseptic Processing, Buenas prácticas de..., Sistema de gestión de..., Administración de..., Validación, Industria farmacéutica