Location: Lisbon, Portugal (Hybrid)
What We Need: ValGenesis Portugal is looking for a quality manager and take charge of driving excellence in our quality management processes. In this key role, you'll lead the implementation of a risk-based approach to compliant GxP computerized systems, execute our validation strategy, and support the entire product development life cycle. Your impact will extend to coaching and guiding our QC team, overseeing internal audits, and promptly addressing customer concerns with effective corrective measures. We're seeking a dynamic individual with a meticulous eye for detail, outstanding written and verbal communication skills in both English and Portuguese and a solid background in software development and quality control.
Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ
What You’ll Be Doing (Responsibilities):
- Overall responsibility for Quality Management Processes in line with the standard requirements of ISO 9001:2015 and ISO: 27001:2013.
- Knowledge of Risk-Based Approach to Compliant GxP Computerized Systems - GAMP® 5
- Implementation of the validation strategy for ValGenesis computerized systems and associated infrastructure.
- Support the product development life cycle for computerized systems with change controls, and deviations management ensuring that relevant documentation is in place and maintained according to the ValGenesis requirements.
- Understanding of computerized systems validation, lifecycle management, and 21 CFR Part 11 requirements.
- Coaching and mentoring of QC team members.
- Defines, documents, and implements QMS for all product development areas including support functions.
- Planning and implementing promotional campaigns for the specified regions.
- Responding to and managing Customer Complaints by investigating and implementing countermeasures for corrective and preventive measures.
- Conduct and manage the internal audits including vendor audits and report to the Head of Quality / Management
- Provide support to department heads and functional heads to identify improvement areas by identifying the root causes and propose the best corrective and preventive actions.
- Creating innovative solutions with problem-solving methods to bring in leads.
- Customer focus with an eye for details, analysis, and continual improvements.
- Managing with day to day quality control activities as per quality plan requirements and tracking them to closure.
- Up to date with the latest development of the standards and other regulatory needs in the pharmaceutical industry and maintain compliance with the QMS.
- To review and approve the various validation documents both internally as well as during product deployment for customers. The documents are routed in a workflow with a predefined SLA and the expectation is to review thoroughly without any defects or missing content.
- Support Information Security Management System in terms of reviewing documents and ensuring that they are in line with the requirements of security standards.
- Improve compliance through continual improvement programs across the organization and Quality by design.
- Support the training department in terms of the training plan, conduct of training, and management for the ValGenesis.
- Work experience in Quality Control specific to software development for the pharmaceutical/life sciences domain
- Knowledge of statistical and quantitative methods
- Degree in Business administration /Management with QA specialization
The Nice to Haves (Preferred Qualifications):
- Additional knowledge of foreign languages
- Prior experience supporting a fast-growing organization
- Successful track record of managing ongoing client relationships
- Knowledge of Incident Management System
More About US...
Headquartered in South San Francisco, since 2005 we’ve grown into a global organization with offices around the world. ValGenesis is the global market leader and fastest-growing provider of digital validation software for life science companies. We are proud to partner with 30 of the top 50 global pharmaceutical and biotech companies.
Our SaaS platform and flagship product, Validation Lifecycle Management System (VLMS), is the first enterprise software solution to fully electronically manage the validation process lifecycle, accelerating time to market, reducing manufacturing costs, and increasing quality and regulatory compliance for our customers. As a first mover supporting the pharmaceutical, biotech, and medical device industries, ValGenesis is pioneering innovation over web, mobile, IoT, and AR channels. For more, see the
ValGenesis provides a competitive base salary, top tier benefit options inclusive of health, dental, vision, Observance of Company Holidays, and PTO (paid time off). We are searching for talent that is driven to execute results to help us accomplish our goals while remaining committed to customer success, collaborating cross-functionally, openly communicating, and operating with responsibility.
- ValGenesis is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, age, national origin, religion, marital status, sexual orientation, ancestry, color, gender identity/expression, family / medical care leave, genetic information, medical condition, physical/mental disability, political affiliation, status as a protected veteran, status as a person with a disability, or other characteristics protected by laws or regulations.