Responsible Person

Bachem

. Act as the designated RP/FvP for assigned activities under Bachem’s Swiss establishment licence .

Posted 11/12/2026full-timeBubendorf • SwitzerlandLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmaceutical quality assurance, regulatory compliance, and technical supervision, with a strong focus on GMP/GDP standards and effective communication with stakeholders. Proficient in managing quality events, batch disposition, and CAPA processes while ensuring patient safety and product integrity.

Highest-signal resume keywords

Pharmaceutical Quality AssuranceGMP/GDP ComplianceBatch Disposition ManagementRegulatory Decision-MakingGerman And English Language Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmaceutical Quality SystemDeviation ManagementCAPA ProcessesChange ControlProduct-Quality DefectsInvestigationsQuarantine ProceduresSupply RestrictionsRecall ManagementTechnical Supervision

Soft Skills

Clear CommunicationTrustworthinessIntegrityScientific JudgementConfidence In Interactions

Industry Keywords

Swiss Pharmaceutical LegislationEU GMPICH ExpectationsPharmaceutical ManufacturingBiotechnologyAPI ManufacturingQuality Governance ProcessesRisk-Based Quality Culture

About the role

Key responsibilities & impact

Act as the designated RP/FvP for assigned activities under Bachem’s Swiss establishment licence
Ensure effective technical supervision
Provide independent oversight of manufacturing, testing, batch disposition, storage and distribution activities under Swiss GMP/GDP requirements and Bachem’s Pharmaceutical Quality System
Make or support independent quality and regulatory decisions for significant deviations, investigations, CAPAs, changes, product-quality defects and other critical quality events
Ensure escalation and measures where product quality, patient safety or regulatory compliance may be affected, including quarantine, supply restrictions, withdrawal or recall
Support inspections, establishment-licence activities and communication with stakeholders and health authorities
Represent Quality in customer audits, quality meetings and critical product or supply discussions
Contribute to key quality governance processes and promote a risk-based quality culture

Requirements

What you’ll need

University degree in pharmacy, chemistry or another relevant scientific discipline
Education, technical knowledge and relevant professional experience and suitability for the authorised activities
Substantial experience in pharmaceutical, biotechnology or API manufacturing
Strong knowledge of GMP/GDP, Swiss pharmaceutical legislation and relevant EU GMP and ICH expectations
Demonstrated experience in batch disposition, deviations, investigations, CAPA, change control, complaints, product-quality defects and recalls
Strong scientific judgement, integrity, trustworthiness and ability to take independent, well-founded decisions
Ability to ensure direct technical supervision through appropriate availability, on-site presence and workload for the approved scope
Clear communication and confidence in interactions with authorities, customers and senior stakeholders
Trustworthiness and independence in exercising the RP/FvP function
Strong German and English language skills are essential

Benefits

Comp & perks

A dynamic and rapidly growing work environment with internal development opportunities
Employee development through numerous internal and external training opportunities
60% coverage of pension fund contributions by Bachem AG
Option for extra-mandatory pension provision with the Pension Plan Plus
Access to benefits platforms with discounts from external partners
Fresh, healthy and varied food in the staff restaurant
A wide range of free sports activities on the Bachem Campus