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Quality Manager

Budapest

About Chemaxon

Chemaxon is an industry-leading cheminformatics software company helping early-stage drug discovery and chemistry research for more than 20 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! 

About the position

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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When you apply to a job on this site, the personal data contained in your application will be collected by Chemaxon as a controller, which is located at Váci út 133., Budapest, Hungary, 1138, and its affiliates (hereinafter “Chemaxon”) and can be contacted by emailing hr-team@chemaxon.com. Your personal data will be processed for the purposes of managing Chemaxon’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by Chemaxon, which are the solicitation, evaluation, and selection of applicants for employment. 
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