Dominic Dominguez Cruces
Senior Manager External Quality at Actelion (now Janssen Pulmonary Hypertension)- Claim this Profile
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Deutsch Native or bilingual proficiency
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Englisch Professional working proficiency
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Französisch Elementary proficiency
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Spanisch Elementary proficiency
Topline Score
Bio
LinkedIn User
To work with Dominic, it has been a pleasure from personal and professional point of view. Dominic is an excellent professional and one of the most prepared on his areas of expertise. During the time I had the opportunity to work with him, he demonstrated excellent leadership skills and strong ability to motivate colleagues.
Romy Wiedemann
In my time at Crucell Switzerland AG, I have worked with Dominic Dominguez (Group Head Lechables & Extractebles) as a colleague. He has following noticeable strenghts: - pro-active, engaging for new ideas which are proposed to improve the company - initiating and pushing well developed processes - optimistic once in a worst situation I wish him well for his future, Kind Regards Romy Wiedemann M.Sc. Head Facility Management Crucell Switzerland AG, Johnson & Johnson Company Rehhagstrasse 79, CH-3018 Berne Switzerland Phone: +41 (0)31 888 5252 Fax: +41 (0)31 888 5199
LinkedIn User
To work with Dominic, it has been a pleasure from personal and professional point of view. Dominic is an excellent professional and one of the most prepared on his areas of expertise. During the time I had the opportunity to work with him, he demonstrated excellent leadership skills and strong ability to motivate colleagues.
Romy Wiedemann
In my time at Crucell Switzerland AG, I have worked with Dominic Dominguez (Group Head Lechables & Extractebles) as a colleague. He has following noticeable strenghts: - pro-active, engaging for new ideas which are proposed to improve the company - initiating and pushing well developed processes - optimistic once in a worst situation I wish him well for his future, Kind Regards Romy Wiedemann M.Sc. Head Facility Management Crucell Switzerland AG, Johnson & Johnson Company Rehhagstrasse 79, CH-3018 Berne Switzerland Phone: +41 (0)31 888 5252 Fax: +41 (0)31 888 5199
LinkedIn User
To work with Dominic, it has been a pleasure from personal and professional point of view. Dominic is an excellent professional and one of the most prepared on his areas of expertise. During the time I had the opportunity to work with him, he demonstrated excellent leadership skills and strong ability to motivate colleagues.
Romy Wiedemann
In my time at Crucell Switzerland AG, I have worked with Dominic Dominguez (Group Head Lechables & Extractebles) as a colleague. He has following noticeable strenghts: - pro-active, engaging for new ideas which are proposed to improve the company - initiating and pushing well developed processes - optimistic once in a worst situation I wish him well for his future, Kind Regards Romy Wiedemann M.Sc. Head Facility Management Crucell Switzerland AG, Johnson & Johnson Company Rehhagstrasse 79, CH-3018 Berne Switzerland Phone: +41 (0)31 888 5252 Fax: +41 (0)31 888 5199
LinkedIn User
To work with Dominic, it has been a pleasure from personal and professional point of view. Dominic is an excellent professional and one of the most prepared on his areas of expertise. During the time I had the opportunity to work with him, he demonstrated excellent leadership skills and strong ability to motivate colleagues.
Romy Wiedemann
In my time at Crucell Switzerland AG, I have worked with Dominic Dominguez (Group Head Lechables & Extractebles) as a colleague. He has following noticeable strenghts: - pro-active, engaging for new ideas which are proposed to improve the company - initiating and pushing well developed processes - optimistic once in a worst situation I wish him well for his future, Kind Regards Romy Wiedemann M.Sc. Head Facility Management Crucell Switzerland AG, Johnson & Johnson Company Rehhagstrasse 79, CH-3018 Berne Switzerland Phone: +41 (0)31 888 5252 Fax: +41 (0)31 888 5199
Experience
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Actelion (now Janssen Pulmonary Hypertension)
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Switzerland
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Pharmaceutical Manufacturing
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500 - 600 Employee
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Senior Manager External Quality
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Jan 2022 - Present
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Team Leader QA Quality Systems / Pharma GMP Auditor
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Nov 2018 - Dec 2021
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QA Compliance Expert - Supplier Management
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Jun 2017 - Oct 2018
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Process Expert PU Liquid Steriles
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Jul 2014 - Jun 2017
Process Expert in a high volume sterile cGMP production plant with daily role responsibilities for, but not limited to: • ensure process safety, quality, registration and compliance• lead quality related investigations and complaints using Trackwise AQWA System• process & project change management in Agile CCEX System• coaching & training of shop floor staff (approx. 80 FTE) on related production processes• identification & implementation of process improvements• co-responsible for in time quality and on time production with adherence to NOSSCE (Novartis Operational Standards for Supply Chain Excellence) planning• adaption and improvements of Master Batch Records (MBR) and Standard Operation Procedures (SOPs)• support for global audits and inspections (SME and back office team member)• single point of contact (SPOC) in regards to cleaning validation aspects within PU• co-SPOC for thermal requalifications of processes and equipments• tracking and communicating of PU quality and compliance KPIs • foster and assure an efficient and respectful working environment with all stakeholders
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The Janssen Pharmaceutical Companies of Johnson & Johnson
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Group Head / Scientist
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Jul 2013 - Jun 2014
• Recruitment and supervision of a local E&L team and leading the department strategically and organizationally • Built up of a dotted lined, cross functional, transnational E&L team of each manufacturing site• Establishment of a global Crucell leachables & extractables strategy for Process Development and Marketed Products to meet expectations of Health Authorities while assuring Business Continuity• In-sourcing of analytical methods to built up sustainable in-house E&L studies• Support of submission of dossiers and during audits and inspections• Responsible for department budget and employee talent management
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Scientist Extractables & Leachables
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Jan 2013 - Jun 2013
• Alignment with common industry trade organization and global J&J and Janssen experts• Built up of an open cross-company communication channel• Overall project management of extractables studies and GMP leachables analysis for global Crucell products• Leachables and extractables studies director for study design, samples, vendors and CROs• Supervision of several sub teams and associated teams with external partners• Issuing of a global Guidance document
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Project Manager Extractables & Leachables
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Jan 2012 - Dec 2012
within Pharmaceutical & Analytical Development Berne.Responsibilities:• Establishment and implementation of a global Crucell E&L strategy• Cross company wide alignment of procedures
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Process Engineer Qualification & Validation
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Jan 2010 - Dec 2011
within Process Development• Review and approval of several qualification and validation documents delivered by external project members• Performance of FATs, SATs • Preparation of high level qualification and validation documents • Project coordination and planning • Deviation, CAPA, Risk and Change management
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Manufacturing Support Engineer
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Oct 2009 - Dec 2009
Cleaning Validation and Process Validation
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Graduand
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Mar 2009 - Oct 2009
Qualification (DQ, IQ, OQ, PQ) of a new chromatography skid used for purification of monoclonal antibodies
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Internship
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Sep 2008 - Feb 2009
Process improvements
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University of Applied Sciences Offenburg
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Offenburg, Baden-Württemberg, Deutschland
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Student Research Project
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Mar 2008 - Jul 2008
Commissioning and usage of an impedance spectroscope for the characterization of microorganism in a microbial fuel cell Commissioning and usage of an impedance spectroscope for the characterization of microorganism in a microbial fuel cell
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Breisgaumilch / Schwarzwaldmilch
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Freiburg / Offenburg
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Internship
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Sep 2006 - Jul 2007
Implementation of an EDMS for the microbiological laboratory Implementation of an EDMS for the microbiological laboratory
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