Senior Quality Assurance and Pharmacovigilance Manager

Veristat; Basel; Remote; CHF 180,000 - 240,000; Full time

Benefits offered by this job

Remote working (60-80%)

Flexible time off

Paid holidays

Health insurance (KTG)

Tuition reimbursement

Pension plans

Job summary

Veristat seeks an experienced Senior Quality Assurance and Pharmacovigilance Manager to lead QA and PV activities under Swiss and EU legislation. The role includes acting as QA Designee for SFL-DE and ensuring the integrity of the QMS across manufacturing and distribution of medicinal products.

The candidate should have 5–10 years of GxP experience, degree in life sciences or pharmacy, and strong knowledge of GMP and GDP, with English proficiency and local language capabilities.

Qualifications

• 5-10 years’ GxP experience and be trustworthy, including experience as RP (FvP) or DRP (stellv. FvP)
• Degree in pharmacy or in life sciences showing experience in manufacturing and/or distribution of ready-to-use medicinal products
• Knowledge of medicinal products and guidance, especially GMP and GDP
• Knowledge of GVP and GCP is advantageous
• Excellent written and spoken English; ability to interact with local authorities in German or French is beneficial

Responsibilities

• Act as Senior QA & PV Manager and maintain Swiss QMS per Swiss/EU legislation
• Support QA team to establish new or maintain existing Pharmaceutical QMS
• Act as QA Designee for SFL Pharmaceuticals Deutschland GmbH (SFL-DE) reporting to SFL-DE Head QA
• Collaborate with regulatory and cross-functional teams to ensure compliance and inspection readiness
• Contribute to continuous improvement for QA and PV processes

Skills

GxP

RP/DRP experience

GMP/GDP/GVP/GCP knowledge

English proficiency

Management experience

Education

Degree in Pharmacy or Life Sciences

Job description

Job Description

Senior Quality Assurance and Pharmacovigilance Manager The position holder acts as Senior Quality Assurance and Pharmacovigilance (QA & PV) Manager. Maintain an in-depth understanding of the purpose and components of Swiss Pharmaceutical Quality Management Systems (QMS), as governed by Swiss and EU legislation. Support the QA team in performing the required and relevant activities to establish new and / or maintain existing Pharmaceutical QMS.

Job Description
Senior Quality Assurance and Pharmacovigilance Manager The position holder acts as Senior Quality Assurance and Pharmacovigilance (QA & PV) Manager. Maintain an in-depth understanding of the purpose and components of Swiss Pharmaceutical Quality Management Systems (QMS), as governed by Swiss and EU legislation. Support the QA team in performing the required and relevant activities to establish new and / or maintain existing Pharmaceutical QMS.
Additionally, the position holder also acts as QA Designee for SFL Pharmaceuticals Deutschland GmbH (SFL-DE), reporting to the SFL-DE Head QA.
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What We Offer

• Benefits vary by location and may include:
• Remote working (60-80%)
• Flexible time off
• Paid holidays
• Health insurance (KTG)
• Tuition reimbursement
• Pension plans
  

What We Look For

• Must have the necessary training, expertise and 5-10 years’ GxP experience and be trustworthy, including experience as RP (FvP) or DRP (stellv. FvP).
• Must hold a degree in pharmacy or in life sciences demonstrating the necessary experience in the manufacturing and\/or distribution of ready-to-use medicinal products.
• Has knowledge of medicinal products and guidance, in particular the international legislation in relation to GMP and GDP.
• Ideally has knowledge of GVP and GCP knowledge in addition is of advantage.
• Managerial experience of advantage.
• Has excellent knowledge of written and spoken English.
• Additionally, to be able to interact with the local authorities, the RP/DRP shall speak one of the official local languages of the canton where the health authority inspection takes place and where the licensed site of the company is located (either German or French, knowledge of both is of advantage).
• Has excellent knowledge of written and spoken English and German and / or French
• Must live within reasonable distance of the site for which he /she is acting as RP or DRP. As a guidance value the RP/DRP should live within approximately two hours travelling time to the site he/she is acting for as RP/DRP.
• In order to enable support in RP/DRP oversight and facilitate collaboration with relevant functions, the RP/DRP will maintain presence at SFL offices regularly.

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.