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

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career and dynamic culture

Inclusive and ethical workplace

Compensation programs recognizing high

Benefits dependent on role and locale

Zusammenfassung

Lonza is seeking a QA Manager (f/m/d) within QA Analytics in Visp, Switzerland. You will ensure GxP compliance, data integrity and regulatory adherence across QC processes, acting as a liaison between QC and QA Operations and engaging with senior site stakeholders.

As a Quality and Compliance representative, you will drive CAPA, investigations and SOP revisions while partnering with cross-functional teams to uphold quality standards and support regulatory inspections.

Qualifikationen

• Academic degree in Chemistry/Biochemistry/Biotechnology/Life Science or related field.
• Profound working experience in the pharmaceutical industry within QC/QA.
• Analytical expertise with method validation, change management and deviation handling.
• Strong background in cGMPs, USP/EP regulations; audits with Health Authorities.
• Experience in cross-functional teamwork and regulatory inspections.

Aufgaben

• Represent QA Analytics in cross-functional teams and meetings.
• Ensure GxP requirements and SOPs are followed across QC and QA operations.
• Review and approve QC/AD documents, method transfer and validation files.
• Drive CAPA items and investigations to completion and timely closure.
• Provide SME guidance for QA Analytics and support regulatory inspections.

Kenntnisse

Cross-functional teamwork

Excellent English communication

Ausbildung

Chemistry/Biochemistry/Biotechnology/Life Science

Jobbeschreibung

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

The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits

What you will do:

• Represent QAAnalytics in cross-functional teams and meetings

• RepresentQA concerns to the Quality Control (QC) and ensure thatGxPrequirements are met andglobal/local procedures(SOP)are followed

• Review andapproveQC/AD related documents(e.g.method transfer documents, method validation documents, SOP, etc.)

• Review andapproveTW records related to QC processes

• EnsureQCdeviations/investigationsare appropriately investigated anddocumented following regulatory requirements

• Actas decision-makerduring QC deviations/investigation process

• Responsible to driveQA Analytics and QC relatedCAPA and EffectivenessCheckitems to completion andtimelyclosing

• Ensure that documents are correct and adhere to SOPs and tocustomer’srequirements

• Represent specificfunctionalareas asQA AnalyticsSubject Matter Expert (SME) and provideguidance and recommendations in these areas to internal or externalstakeholders

• Supportanddrivespecific projectsas well as reviseand approveSOPs

• Support QCduring regulatory inspectionsandcustomer audits.

What we are looking for:

• Academic degree in Chemistry/Biochemistry/Biotechnology/ Life Science or related field

• Profound working experiencein the pharmaceutical industry within QC/QA required

• Founded analyticalexpertiseand experience with analytical method validation, change management, deviation management andOOxinvestigations

• Strong background in cGMP regulations, incl. USP, European and Japanese Pharmacopeia

• Auditing experience and experience in interaction with Health Authorities (FDA, Swissmedic)

• Experience in working in cross-functionalteams

• Excellent verbal and written communication in English required; German isadvantageous.

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.