QA Manager - Computerized Systems Validation (CSV)

Roche

  • Kaiseraugst, Argovie
  • CDI
  • Temps-plein
  • Il y a 7 jours
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionWe are currently seeking a highly motivated and experienced QA Manager specializing in Computerized Systems Validation (CSV) to join our team in Basel/Kaiseraugst. In this critical role, you will be responsible for ensuring the quality, compliance, and validation of computerized systems and infrastructure used in production, laboratories, and storage facilities across our sites. You will play a vital part in maintaining compliance with regulatory and site-wide requirements while driving the implementation of advanced digital solutions and fostering a culture of continuous improvement.This role includes oversight of quality assurance tasks in both commercial DS (Drug Substance) and DP (Drug Product) production as well as clinical trial production.The Opportunity
Your main responsibilities will include:Review and approve qualification and validation documents for various production and lab systems.Assess and approve change requests and manage deviations within VEEVA or ServiceNow.Support root cause analyses and contribute to the development and execution of CAPAs.Review and approve periodic system qualification reviews to ensure compliance.Provide guidance for risk assessments and risk analyses.Collaborate with internal and external teams to meet safety, quality, and efficiency goals.Drive cross-functional process improvements and foster collaboration across departments.Stay updated on regulatory changes, internal guidelines, and new digital technologies.Who You Are:
You thrive in a fast-paced, dynamic environment, enjoy tackling new challenges, and bring a problem-solving mindset to your role. You are motivated to drive continuous improvement and innovation, always seeking better ways of doing things. You take ownership of your work, lead with initiative, and demonstrate strong communication and collaboration skills.To excel in this role, you bring:Education and Experience: A degree in Pharmacy, Natural Sciences, IT, or Engineering with several years of professional experience in a GxP environment, ideally in CSV or IT/OT.Compliance Expertise: A strong understanding of GxP, data integrity, and regulations for computerized system validation.Communication Skills: Proficiency in both German and English, both written and spoken.Technical Acumen: Strong analytical thinking with an interest in digitalization, IT, AI, and data integrity.Leadership and Collaboration: The ability to lead projects, influence stakeholders, and work effectively with others to solve problems.What We Offer:We have two openings and welcome both full-time and part-time applications.The opportunity to leverage cutting-edge technologies in a forward-thinking, global pharmaceutical environment.A collaborative and inclusive workplace culture that values innovation, respect, and teamwork.Professional growth opportunities and exposure to strategic initiatives.Competitive salary and comprehensive benefits.This is a unique opportunity for professionals keen to contribute to the advancement of pharmaceutical quality assurance while playing a role in the digital transformation of the industry. If you are passionate about quality, compliance, and innovation, we encourage you to apply!Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let’s build a healthier future, together.Roche is an Equal Opportunity Employer.

Roche