QA Manager, QA Analytics 80-100% (f/m/d)

Lonza; Stalden (VS); Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

An agile career and dynamic working文化

An inclusive and ethical workplace

Compensation programs that recognize高绩

A variety of benefits dependant on rol

Zusammenfassung

Lonza is seeking a QA Manager for QA Analytics to ensure QC processes meet GxP, data integrity, and regulatory standards. You will interface between QC and QA Operations and collaborate with senior site stakeholders.

Lead QA Analytics SME activities, review critical validation and SOP documents, and drive CAPA initiatives while supporting regulatory inspections and audits.

Qualifikationen

• Academic degree in Chemistry/Biochemistry/Life Science or related field.
• Profound working experience in the pharmaceutical industry within QC/QA required.
• Analytical expertise including method validation and deviations.
• Strong background in cGMP regulations (USP, EP).
• Auditing experience and interaction with Health Authorities (FDA, Swissmedic).
• Excellent verbal and written communication in English; German is advantageous.

Aufgaben

• Represent QA Analytics in cross-functional teams and meetings.
• Review and approve QC/AD related documents (e.g., method transfer/validation, SOPs).
• Drive QA Analytics CAPA and Effectiveness checks to completion.
• Ensure SOPs and documents meet customer requirements and SOPs.
• Support QC during regulatory inspections and customer audits.

Kenntnisse

GxP compliance

QA analytics

Cross-functional collaboration

English communication

Ausbildung

Bachelor’s degree in Chemistry/Biochemistry/Life Science

Jobbeschreibung

QA Manager, QA Analytics 80-100% (f/m/d)

Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

The QA Manager (f/m/d) within QA Analytics is ensuring that all processes within the QC functional areas comply with GxP, data integrity and regulatory requirements as well with internal/external quality standards. As a Quality and Compliance representative for particular functional area, you are a key member in cross-functional teams, serving as an interface between QC and QA Operations and interact with senior stakeholders across the site.

What you will get:

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance
• A variety of benefits dependant on role and location
• Represent QA Analytics in cross-functional teams and meetings
• Represent QA concerns to the Quality Control (QC) and ensure that GxP requirements are met and global/local procedures (SOP) are followed
• Review and approve QC/AD related documents ( e.g. method transfer documents, method validation documents, SOP, etc .)
• Review and approve TW records related to QC processes
• Ensure QC deviations /investigations are appropriately investigated and documented following regulatory requirements
• Responsible to drive QA Analytics and QC related CAPA and Effectiveness Check items to completion and timely closing
• Ensure that documents are correct and adhere to SOPs and to customer’s requirements
• Represent specific functional areas as QA Analytics Subject Matter Expert (SME) and provide guidance and recommendations in these areas to internal or external stakeholders
• Support and drive specific projects as well as r evise and approve SOPs
• Support QC during regulatory inspections and customer audits.

What we are looking for:

• Academic degree in Chemistry/Biochemistry/Biotechnology/ Life Science or related field
• Profound working e xperience in the pharmaceutical industry within QC/QA required
• Founded analytical expertise and experience with analytical method validation , change management, deviation management and OOx investigations
• Strong background in cGMP regulations, incl. USP, European and Japanese Pharmacopeia
• Auditing experience and experience in interaction with Health Authorities (FDA, Swissmedic)
• Excellent verbal and written communication in English required; German is advantageous .

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.