A few features about Quality & Compliance @ Schollmeier
Quality Management
Certified *QM Manager* (ISO 9001 : 2015)
QMS Implementation
QMS Tracking and Managing
Quality Assurance Management
Overall Quality Management. Assessment of processes and interfaces, increase efficiency by LEAN Management.
Compliance Management
Certified *Compliance Officer* (ISO 19600 : 2016)
Risk Management (ISO 14971 : 2020)
Regulatory Support (Post Market Surveillance and Vigilance)
Ensuring aligned Compliance for the processes, interfaces and the overall business.
Audit Management
Certified *QM Auditor* (ISO 19011 : 2018)
1st and 2nd party Auditing
Internal Audits
CMO Auditing
Selfassessment and status quo to ensure succesful 1st and 2nd party Audits.
Supplier assessment and Auditing.
Services
Short- and midterm projects
Flexible hourly support
Understanding the overall deliverables and interfaces are key for adjusting a LEAN and efficient process landscape.
GxP
GdocP
GLP
GCP
GMP
GDP
Regulatory
AMWHV and AMG
MPG
Post Market Survailance
Vigilance
Pharmacopoeia
Project and Quality Management
QMS Implementation
New Product Introduction
Product launch
Technical Transfer Lead
Trackwise (Change Management,
Deviation and CAPA Management)
Business Development Support
SmartSheet
Jira
Confluence
Skillset
KPIs and KVP
LIMS
MS Office
SAP
MacOS and Windows
ISO 9001
ISO 19011
ISO 13485
ISO 14971
ISO 19600
About
Quality & Compliance
combined together !
I am a Biochemist by heart, and passionate about Quality & Compliance. I have a robust background in the Pharmaceutical and MedTech industries. My expertise encompasses the entire spectrum of Quality Management Systems, ranging from analytical laboratories to the digitalization of GXP processes.
In my roles as Director Quality Management, Chief Quality Officer, and Commercial Quality Manager, I have successfully led projects, including QMS (both paper-based and digital) implementation, Audit readiness initiatives, New Product Introduction (NPI) projects, and fast track applications in the pharmaceutical sector.
With experience in Audit Management (on top TÜV certified Auditor), I have conducted first-, second-, and internal-audits all the way up to supporting third-party audits by various authorities such as FDA, EMA, China, and Mexico.
In my different Quality Management roles, I provided oversight for GLP, GCP, and GMP settings, managed SOP portfolios, DMS (document management system), LMS (learning management system) and ensured compliance across organizational and supplier processes.
Beyond Quality topics, I have contributed to start-ups with Quality & Regulatory Support, bridging the gap between quality and regulatory aspects, including PSUR, general reporting and supporting Pharmacovigilance (PV) system setup.
Armed with a Quality mindset developed in corporate settings and a nuanced understanding of start-up needs, especially in forging partnerships, my focus lays on creating and connecting supplier and collaboration partners on both small and large scales.
In my commitment to positive change, I offer a comprehensive portfolio of Quality & Compliance Management, all backed by a solid scientific foundation.
* Develop to serve the patient – Change for the better – Creating a SMART life science community*
For more information about me:
Testimonials
Dr. Yvette Schollmeier has been an invaluable collaborator. In our interactions, she demonstrated exceptional expertise in connecting us with suitable CROs. Yvette’s approachable demeanor and proactive nature made our collaboration smooth, and her insights were instrumental in enhancing our project outcomes. I highly recommend her for her outstanding support and professionalism.
PhD Maria Riera Piqué Borràs
Preclinical Development Manager @ Weleda AG
Yvette listens carefully to clients needs and offers tailored solutions. She has the right timing and level of detail to provide information easily understandable for her audience. She is empathic and creates an atmosphere of reliability and accountability during meetings.
Dr. Jörg Ohl
Senior Director Business Develoment @ AGC Biologics
Yvette has a solid background and extensive experience in the industry. This gives her a deep understanding of the needs of startups, particularly in forming partnerships. She is inventive and proactive. Not only did she assist in promoting my company’s services through Pharmatching, but she also played a pivotal role in understanding the focus of our research, despite it being outside her primary area of expertise. Yvette excelled in connecting me with the right companies and organizations, and she did so without any profit motive.
Moreover, when I expressed the need to patent our software, Yvette took the initiative to identify and contact German patent agencies. She went above and beyond by facilitating and participating in video calls, not for personal gain, but to enrich her own knowledge and experience. Currently, Yvette is returning to her original profession in Quality & Compliance, a field in which she is highly skilled.
Despite business development not being her primary area of expertise, she has impressed me with her aptitude and effectiveness in this field. Her background in Quality & Compliance only reinforces her comprehensive skill set.
PhD Thomas Evangelidis
CEO & CSO and Founder @ AI/ffinity
Yvette is an exceptional professional who embraces new challenges on a daily basis. During the time we have worked together, she has always been at the forefront of new changes, facing challenges and identifying opportunities. Her innovative and proactive vision has allowed us to implement significant improvements to our processes and services.Yvette is an exceptional professional who embraces new challenges on a daily basis.
During the time we have worked together, she has always been at the forefront of new changes, facing challenges and identifying opportunities. Her innovative and proactive vision has allowed us to implement significant improvements to our processes and services.
Gustavo Anschau
Digital Marketing Specialist
Yvette is an incredibly positive force in the global Pharma arena. I have worked with her for over a year now and her Project Management skills are strong and deliberate.
She is a great people person with a strong scientific background, and she is a pleasure to work with.
Howard Abroms
Director Global Business Development @ CONTINUUM
Yvette is creative, driven and strong. Coupled with her lightning-fast thinking and drive to create and pursue opportunities she’s great to connect and work with.
I recommend working with Yvette wholeheartedly.
Rob te Velde
CEO & Founder Coaching & Consultancy @ Capteer
It’s my pleasure to recommend Yvette as a Business Product Owner. Her exceptional leadership and unwavering dedication to our projects have been instrumental in achieving outstanding results. Yvette’s innovative approach, coupled with her superb communication skills, consistently elevates the team’s performance. Working with her has not only been professionally rewarding but also a genuinely inspiring experience.It’s my pleasure to recommend Yvette as a Business Product Owner. Her exceptional leadership and unwavering dedication to our projects have been instrumental in achieving outstanding results. Yvette’s innovative approach, coupled with her superb communication skills, consistently elevates the team’s performance. Working with her has not only been professionally rewarding but also a genuinely inspiring experience.
Amir Mohammad Amiri
Senior Software Engineer
Yvette worked with me in the same regional quality team where she was managing the DACH region in Commercial Quality. She knows her QMS through and through and is able to implement efficient and relevant processes.
She has an entrepreneurial spirit and will trailblaze a way forward if she believes in the cause, giving it her all; and with that passion, to bring others along that journey.
She is never afraid to speak her mind and will challenge if she thinks there is a better way forward. She also has a good sense of humour if you want a day of hard work and laughter together!
B.Sc. Phebe Tay
Global R&D Manager @ Reckitt
Yvette is very passionate about her job and really lives for quality. Her knowledge about GMP and quality guidance is impressive as well as her project management skills. Based on that she was able to improve processes of any kind within the company easily. Potential risks and gabs were analyzed within a shorten of time and preventive actions were implemented by her with full speed. Yvette is very well structured and helped also the team to focus on a smart priority setting. With her in our team we were always sure we are on the right way with our project – independent of the complexity.
For the team, she was always a go-to person for any kind of challenges.
Yvette is in inspiration for myself and her motivated attitude is contagious. It was a pleasure to work with her.
M.Sc. Katharina Landwehr
Head of Production Management @ MYR Pharmaceuticals
I was able to work with Yvette for a short, but very fruitful time.
We were able to complement each other through various topics; Yvette brought some fresh breeze into the group, bringing new good ideas and moving the Quality spirit forwards.
Her huge knowledge being already operative in some global player companies is obvious and invaluable.
Also on personel level she is helpful, but also demanding, finding the right balance of both. All to suit the business and employees needs. It is a pity that we were not able to work longer together as I think that we would have established an excellent relationship, complementing the best out of the HEalth and Hygiene Home business.
Alexander Schäfer
IMEx Quality Compliance Manager @ Reckitt&Benckiser GmbH
I was able to work with Yvette and it was a great experience. I was very impressed by her extraordinary knowledge in Quality Management and was able to gain many new impressions. Her profound knowledge of quality and her eye for the detail throughout the entire processes are particularly impressive. She is a helpful and reliable expert as you would wish to have for your company.
Marco Klinger
Quality Assurance Manager @ Zamann Pharma Support GmbH
Yvette ist eine sehr aktive und engagierte Mitarbeiterin. Sie ist gut organisiert und arbeitet gerne im Team. Sie ist aufgeschlossen für neue Aufgaben und überzeugt durch ihr souveränes Auftreten.
Eva Kohlstrung
Group Lead QC @ Roche Pharma
My partners & memberships
Find my partners and associations I am teamed up with to achieve maximum outcome for your project/s with me.
Contact
Please feel free to get in touch and discuss possible collaborations.
Phone
Phone: 0049 6221 903 1814
Mobile: 0049 179 749 8057
Info@YvetteSchollmeier.de