Chemaxon is an industry-leading cheminformatics software company helping early-stage drug discovery and chemistry research for more than 25 years. Our clients are top pharmaceutical companies, innovative biotech startups, and leading academic institutions.
We are agile, innovative and friendly, offering compelling opportunities for frequent collaboration and cross-training with teammates and stakeholders.
We operate internationally, with regional teams based in Budapest (HQ), UK, Boston, San Diego and Basel (Switzerland), along with distributors in the Asia Pacific. We have recently been acquired by Certara, a US-based model-informed drug development services and software company. We are in an exciting time of organizational and business growth, so now is the perfect time to join our team!
As a Quality Manager, you'll coordinate the activities required to meet the quality standards supporting the Certara Predictive Technologies (CPT) organisation, ensuring that quality standards are consistent and meet both external and internal requirements. Your role is concerned with monitoring and advising on the performance of the quality management system, producing data and reporting on performance, measuring against set standards.
About your responsibilities
- Oversee and support cross-functional process improvement projects across the CPT organisation
- Manage CAPA and deviation investigations and processes
- Identify and develop continuous improvement opportunities to increase the efficiency of Quality Assurance activities and operations
- Review compliance and adherence to approved software development standards, processes, and procedures and make recommendations on the adoption of industry best-practices
- Participate and support customer & vendor audits
- Define, implement, and maintain quality assurance methodologies and processes and aligning with key stakeholders
- Support quality management systems and validation and procedural tasks when needed
- Approve proposed software changes of GxP and non-GxP systems prior to implementation
- Review all components of the software applications and systems for the software product ensuring proper documentation for each release
- Coordinates activities related to ISO 9001 and 27001 renewal audits (SOP reviews, internal and external audit scheduling and communication with the internal and external stakeholders)
- Ensure training records are up to date and monitor and report compliance across CPT
Experience, skills and knowledge you should bring to us
- 5+ years experience in quality management
- Detailed knowledge with ISO 9001 and ISO 27000 series
- Excellent project management and leadership skills
- Anticipate and resolve issues independently with the understanding of when to seek assistance
- Strong attention to detail, organization, and time management skills
- Ability to work as a team player with multi-disciplinary project teams
What we offer
- Hybrid-way of working (8 days/month home office)
- Private health insurance (Medicover)
- Daily entry into Life1 Fitness Clubs
- Generous annual training budget supporting your professional development (off-site training, international conferences, e-books)
- We work with global Top500 companies (R&D) and leading academic institutions, giving you a chance to gain insights into these dynamically evolving industries.
- Inspiring working environment - leisure and recreation area, playing corner for children, English lessons, yearly user conference with social programs, innovation days
- You will be a valued member of a creative and supportive agile team
- Everyday use of English in a multicultural environment
Location: Budapest, Váci Greens Office Park
Please note, we’re unable to support relocation or sponsor visa for this role.
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What We Do
So, briefly: who are we?
Chemaxon is a leading cheminformatics company, with headquarters in Budapest, Hungary and offices in the US and Switzerland
And what do we do?
We provide chemical software development platforms mostly for the biotechnology and pharmaceutical industries - but any chemist might find us useful.
Why do our users prefer us?
Because we are known for our rapid and high quality technical support, we develop our tools together with our users (the reason we have good quality software); and because we support academic research and teaching like no one else in the industry!
All right, so exactly what are we good for?
Well, among many other things, you can draw & view chemical structures with Marvin Suite; manage and search your compounds with JChem tools; search your database in Excel or in our Instant JChem interface; perform a variety of calculations and predictions; cluster, screen, fragment or synthesize your compounds virtually and deal with Markush structures.
That's it really in a nutshell. If you are interested, contact us or post a message here.
