31.05.2026 aktualisiert

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Senior Quality Assurance Manager in Pharmaceutical / Biotechnology Manufacturing and Distribution

Lupsingen, Schweiz
Lupsingen +50 km
PhD in Biotechnology and Animal Breeding/Genetics
Lupsingen, Schweiz
Lupsingen +50 km
PhD in Biotechnology and Animal Breeding/Genetics

Profilanlagen

CV P. Bobal 22SEP2025.pdf

Skills

SAFePrüfungsrisikoGood Manufacturing PracticesNichtkonformitätsmanagementProduct OwnershipSAP QMLieferantenbewertungBacklogsQualitätssicherung für LieferantenPharmaproduktion
Pharmaceutical Quality Assurance
Expertise in GMP compliance, quality oversight of drug substance manufacturing, and management of quality systems for pharmaceutical products in clinical and commercial phases.
Regulatory Compliance
Comprehensive knowledge of pharmaceutical regulations with experience supporting health authority requests (FDA, EMA, Health Canada, TGA) and ensuring compliance with GMP/GLP/GCLP standards.
Supplier and CMO Management
Specialized in external manufacturing quality oversight, supplier qualification, and management of contract manufacturing organizations (CMOs) including quality agreement negotiations.
Quality Documentation Systems
Proficiency in developing, reviewing and approving SOPs, validation protocols, technical documentation, and quality manuals.
Team Leadership
Experience leading cross-functional teams and managing quality specialists across multiple pharmaceutical manufacturing sites.
Deviation Management
Expertise in handling deviations, change controls, investigations, non-conformity reports, and out-of-specification (OOS) investigations.
Software Systems
Proficient in quality management systems including Veeva QMS, SAP QM Module, MS Office suite, and various document management systems.

Digital Product Ownership - Agile Working under SAFe
  1. Vision & Strategy: Defining the long-term direction of the product and aligning it with broader company objectives.
  2. Backlog Management: Developing, organizing, and prioritizing user stories and features to guide the development team.
  3. Voice of the Customer: Conducting user research, analyzing feedback, and prioritizing features that address customer pain points.
  4. Stakeholder Alignment: Managing expectations and collaborating across departments (marketing, sales, tech, design) to ensure smooth rollout.
  5. Execution & Value Delivery: Guiding the team through the daily delivery cycle and ensuring the product creates tangible business value.

Erfahrung

Berufserfahrungmehr als 10 Jahre
Freelancer seit2025

Sprachen

DeutschverhandlungssicherEnglischverhandlungssicherSlowakischMuttersprache

Projekthistorie

Quality Lead for Global Product Materials

Moderna Switzerland GmbH
Leading cross functional team for externally purchased materials, consumables, medical devices and services in clinical and commercial phases. Supporting APQR establishment, supplier qualification, and quality agreement negotiations.

Quality Assurance – External Drug Substance Manufacturing – Associate Director

Moderna Switzerland GmbH
Team management of QA Managers and Specialists for oversight of DS/DP manufacturing at contract organizations. Maintained GMP compliance, supported regulatory inspections, and managed quality agreements with CMOs.

EXTERNAL MANUFACTURING QA MANAGER - B&P

Bayer Consumer Care AG
Managed end-to-end quality oversight for CMO activities in clinical and commercial phases. Acted as delegate of the Responsible Person ensuring Swiss legislation compliance for quality and compliance tasks.

QA OPERATIONS MANAGER - PH/BT

Bayer Consumer Care AG
Management of team for oversight of DS/DP product manufacturing and support of release activities at Bayer with interface with CMOs. Maintained GMP compliance and supported regulatory inspections.

QA CONTRACT MANUFACTURING MANAGER

Bayer Consumer Care AG
Quality oversight of CMOs activities, monitoring regulatory compliance, negotiation of quality agreements, and acting as Person in Plant during manufacturing.

QA GMP MANAGER

GANYMED Pharmaceuticals AG
Led QA team for R&D and GCLP area, established quality systems for IMP release into clinical trials, and managed vendor qualification and quality agreements.

CMC PROJECT MANAGER

GANYMED Pharmaceuticals AG
Coordinated API production at external CMOs, reviewed documentation for study protocols and reports, and managed temperature-controlled shipments of pharmaceutical ingredients.

SENIOR QUALITY SPECIALIST IN MANUFACTURING AREA

LONZA Biotech, s.r.o.
Led team of QA inspectors, reviewed manufacturing documentation, handled deviations and change controls, and provided QA customer support.

QUALITY SPECIALIST

LONZA Biotech, s.r.o.
Created basis for supplier qualification, selected external testing organizations, prepared specifications for raw materials, and assisted in ISO quality system implementation.

RESEARCH IN BIOTECHNOLOGY AND ANIMAL GENETIC

University Hohenheim
Coordinated international projects in molecular biology and genetics, supervised students, prepared scientific publications, and conducted DNA analysis research.

RESEARCH ASSISTANT

University Hohenheim
Participated in workshop preparation and conducted laboratory work in genetic analysis and DNA purification.

Kontaktanfrage

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