12.11.2023 aktualisiert
100 % verfügbar
Experienced leader in Life Science Industry | Quality | CQV | Regulatory Affairs | Change Management
Oberhausen, Österreich
Deutschland +6
info: Deutschland, Österreich, Schweiz, USA, Italien, Belgien, Singapur
Skills
ElektrotechnikAuditsBiotechnologieBioengineeringBiologieNeubauChange ControlChange ManagementKontinuierliche QualitätsverbesserungEmotionale IntelligenzInterim ManagementISO13485ProjektmanagementPharmaziePharma-Engineering
Senior leader with more than 20 years of experience in Pharmaceutical, Biotech and medical device Business, leading international and intercultural Teams demanding strong technical, organizational, communication and leadership capabilities. Versed in designing and applying Quality Management systems as well as working in cross functional and global teams. Experience in internal and external Audits and Inspections.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2023
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
The CQV Services team supports regional teams in project oversight and acts as a resource for
technical expertise and strategy for all regional projects from proposal stage to facility turnover. Built a
team of subject matter experts who establish business processes, leverage best demonstrated
practices, and ensure a consistent client experience across all regions in the US, Canada and Europe.
Primary focus includes developing capabilities to help regional teams navigate through regulatory
requirements, devise, and execute strategies that meet client timelines, and assess / mitigate risk - all
while driving leaner processes in order to enhance CRB's CQV offering.
Key Achievements:
* Implemented robust business plan to integrate CQV Services in CRB's service portfolio
* Achieved integration targets per Project plan
* Ramped up significant revenue stream for CQV Services in Europe and US
* Supported CQV for a European based mRNA manufacturer establishing modular built clean
rooms for vaccine manufacturing in Africa
technical expertise and strategy for all regional projects from proposal stage to facility turnover. Built a
team of subject matter experts who establish business processes, leverage best demonstrated
practices, and ensure a consistent client experience across all regions in the US, Canada and Europe.
Primary focus includes developing capabilities to help regional teams navigate through regulatory
requirements, devise, and execute strategies that meet client timelines, and assess / mitigate risk - all
while driving leaner processes in order to enhance CRB's CQV offering.
Key Achievements:
* Implemented robust business plan to integrate CQV Services in CRB's service portfolio
* Achieved integration targets per Project plan
* Ramped up significant revenue stream for CQV Services in Europe and US
* Supported CQV for a European based mRNA manufacturer establishing modular built clean
rooms for vaccine manufacturing in Africa
Started as Head of Quality responsible for all Quality aspects for Semperit's medical device Segment
Sempermed, including QMS, CAPA, Change Control, complaint Management, Audits & Inspections,
supplier qualification and continuous improvement activities at three manufacturing sites in Europe
and Asia. In addition, role of Product safety officer acc. Austrian medical device legislation.
From March 2020, additionally took over Responsibility for global Regulatory Affairs, which includes
global Product Registration oversight, planning, application & renewal as well as Contract &
Agreement Management regarding private label manufacturing, Quality and Regulatory Agreements.
In addition, designated Person responsible for regulatory Compliance acc. to European Union Medical
Device Regulation.
Key Achievements:
* Strengthened quality mindset and compliance on the shop floor leading to significant
improvement on product quality and acceptance rate
* Ensured compliance with new EU Medical Device Regulation ahead of Implementation date
* Implemented revised complaint handling process to significantly reduce response time (15
days to 5 days average) while increasing efficiency
* Successfully managed focused continuous improvement projects on Top 3 defect types in
surgical glove manufacturing
* improved QC methodology and system to increase robustness and reduce customer
complaints
* handled notified body audits with zero non-conformity in 2019 as well as ISO13485
Recertification in 2020
* successfully managed regulatory challenges due to Covid-19 pandemic like export bans or
accelerated approval processes with minimal business impact
Sempermed, including QMS, CAPA, Change Control, complaint Management, Audits & Inspections,
supplier qualification and continuous improvement activities at three manufacturing sites in Europe
and Asia. In addition, role of Product safety officer acc. Austrian medical device legislation.
From March 2020, additionally took over Responsibility for global Regulatory Affairs, which includes
global Product Registration oversight, planning, application & renewal as well as Contract &
Agreement Management regarding private label manufacturing, Quality and Regulatory Agreements.
In addition, designated Person responsible for regulatory Compliance acc. to European Union Medical
Device Regulation.
Key Achievements:
* Strengthened quality mindset and compliance on the shop floor leading to significant
improvement on product quality and acceptance rate
* Ensured compliance with new EU Medical Device Regulation ahead of Implementation date
* Implemented revised complaint handling process to significantly reduce response time (15
days to 5 days average) while increasing efficiency
* Successfully managed focused continuous improvement projects on Top 3 defect types in
surgical glove manufacturing
* improved QC methodology and system to increase robustness and reduce customer
complaints
* handled notified body audits with zero non-conformity in 2019 as well as ISO13485
Recertification in 2020
* successfully managed regulatory challenges due to Covid-19 pandemic like export bans or
accelerated approval processes with minimal business impact
Head of Engineering Validation for internal Biologics manufacturing sites globally, leading 1 multinational
and 5 Site based teams comprising of approximately 70 Employees in Asia, Europe and USA.
Responsible for Planning and Performance of all Commissioning, Qualification, Verification (CQV) and
Validation activities including transport validation and Validation Maintenance, global Process
Harmonization and continuous improvement of validation processes, defend validation during Audits
and Inspections. Drive global Projects and Initiatives, implementation of global Efficiency Improvement
initiatives and practice sharing.
As a side assignment, took over Responsibility for Engineering related support activities at one of
Shire's contract manufacturers due to compliance concerns and remediation requirement.
Key Achievements:
* manage integration of Baxalta CQV and Validation into Shire without business disruption
* Stand up Organization for New Shire, staffed all positions within shortest timeframe
* Implemented preferred vendor program for CQV and Validation services resulting in 10%
spend avoidance
* Continuously improved and increased efficiency of validation approaches
* Strengthened compliance for activities in scope
* Helped to resolve supply issue for one of Shire's key products by providing leadership and
onsite support when manufacturing broke down due to engineering related issues at a CMO
and 5 Site based teams comprising of approximately 70 Employees in Asia, Europe and USA.
Responsible for Planning and Performance of all Commissioning, Qualification, Verification (CQV) and
Validation activities including transport validation and Validation Maintenance, global Process
Harmonization and continuous improvement of validation processes, defend validation during Audits
and Inspections. Drive global Projects and Initiatives, implementation of global Efficiency Improvement
initiatives and practice sharing.
As a side assignment, took over Responsibility for Engineering related support activities at one of
Shire's contract manufacturers due to compliance concerns and remediation requirement.
Key Achievements:
* manage integration of Baxalta CQV and Validation into Shire without business disruption
* Stand up Organization for New Shire, staffed all positions within shortest timeframe
* Implemented preferred vendor program for CQV and Validation services resulting in 10%
spend avoidance
* Continuously improved and increased efficiency of validation approaches
* Strengthened compliance for activities in scope
* Helped to resolve supply issue for one of Shire's key products by providing leadership and
onsite support when manufacturing broke down due to engineering related issues at a CMO