Quality Manager

Job Description

• Drive and support analytical method life cycle management (LCM) strategy for in-process, release and stability testing of commercial products
• Leads multisite assay transfers via providing assay transfer strategy and project management with internal and external laboratories
• Serve as SME for analytical methods incl biological, molecularbiological and microbiological methods established in the commercial release testing laboratories
• Take ownership of analytical issues and drive closure quickly, correctly, and permanently for commercial products.
• Serve as in-house analytical / technical expert for troubleshooting and investigating laboratory issues
• Apply statistical analysis for data interpretation and apply chemometric principles to resolve complex analytical issues and applications
• Represent Quality Control on technical product teams
• Collaborate closely with in-house analytical / process technical expert for troubleshooting and investigating laboratory and manufacturing issues
• Author/review/approve method validation/transfer protocols/reports and related SOP's
• Coordinate and lead re-manufacturing of critical reagents for analytical methods
• Author/review/approve quality control plans / qualification protocols/reports and re-test protocols/reports of critical reagents for analytical methods
• Author/review/approve regulatory relevant documents related to analytical methods
• Responsible for technical assessment of methods and changes to methods for compliance to GMP requirements, global Pharmacopeias, industry standards etc.
• Create and enhance collaborative and trusting relationships with internal and external laboratories and internal SMEs and establish effective communication
• Organize and lead cross functional team meetings with internal and external laboratories and SMEs

Competencies and Skills:

• Degree in microbiology, pharmaceutical science, biotechnology, chemistry or closely related field with a a minimum of 3 years experience within a QC laboratory or QA organization (with oversight of QC activities).
• A thorough understanding of pharmaceuticyal QMSystems and respective guidelines and QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred.
• Experience in vaccines and biologics manufacturing and testing and related guideline and knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, preferred.
• Strong technical expertise in microbiology and microbial methods and instrumentation, and statistical methods for data analyses.
• Experienced at leading and delivering successful Technology Transfer activities across the CMO and internal network.
• Strong verbal & written communication skills (including presentation skills). Can effectively articulate complex technical issues to non-technical audience. Proven ability to clearly articulate technical issues concisely and deliver effective presentations on complex technical subjects
• Ability to work in teams
• English is required, German beneficial
• Six Sigma Lean Laboratory, Greenbelt or Blackbelt Certification preferred