Overview
Quality Manager Jobs in Budapest, Budapest, Hungary at Certara
Title: Quality Manager
Company: Certara
Location: Budapest, Budapest, Hungary
Overview
About Certara
Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
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.
As a quality manager, you'll coordinate the activities required to meet the quality standards supporting the CPT organization, ensuring that quality standards are consistent and meets 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.
Responsibilities
- Oversee and support cross-functional process improvement projects across the CPT organization.
- 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 align 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.
- Additional duties, as required.
Qualifications
- 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
- 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
- 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
For some info on Chemaxon, you can check out these videos:
- a shorter one about what we do in a nutshell (~1.5 min)
- and one about the Budapest HQ (~30 min)
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
