Senior Quality Assurance Manager

vor 1 Monat

Visp, Schweiz Lonza Vollzeit
Senior QA Manager Job Description

At Lonza, we're committed to delivering high-quality products and services that make a positive impact on people's lives. As a Senior QA Manager, you'll play a critical role in ensuring our Drug Product Services organization meets the highest standards of quality and regulatory compliance.

Key Responsibilities:
  • Represent Quality Assurance in cross-functional teams and establish interfaces with Manufacturing, QC, and Support Functions to effectively execute tasks related to Drug Product processes.
  • Assess, review, and approve quality records, including deviations, change control, CAPAs, investigations, effectiveness checks, and extensions, in line with current local SOPs.
  • Author, review, and approve GMP-relevant documents and SOPs.
  • Organize DPS Quality Councils and present Drug Product QA topics during customer audits and regulatory inspections.
  • Participate in internal audits as required by the organization.
Project-Specific QA Functions:
  • Act as the point of contact for Drug Product QA-related questions and issues related to manufacturing operations.
  • Support and approve project/product-specific risk assessments.
  • Review and release product-specific documentation, including process descriptions, workflows, recipes, manufacturing protocols, transfer documents, test plans, and parameter lists.
  • Review and approve executive batch records and prepare batch release for the responsible person, including recommendations on disposition status.
Requirements:
  • Bachelor's, Master's, or PhD in Biology, Chemistry, Biotechnology, Life Science, or a related field.
  • Significant work experience in a quality function within a GMP-regulated area.
  • Several years of experience in aseptic processing for Drug Product and associated installations, including filling line, isolator, depyrogenation tunnel, lyophilizer, Media Fill, Aseptic Process Simulation, Environmental Monitoring, and Cleanroom classifications.
  • Language skills: English is a must, German is desired.

At Lonza, we're committed to creating a work environment that's inclusive, diverse, and respectful. We believe that our people are our greatest asset, and we're dedicated to providing opportunities for growth and development. If you're passionate about quality and regulatory compliance, and you're looking for a challenging and rewarding role, we encourage you to apply.

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