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
Über die Firma
