Analytical Quality Assurance Manager (contract) 28373

Job description

Job Description The Analytical Quality Assurance Manager (Contractor) provides specialized analytical quality and technical oversight to support technology transfer and process validation readiness activities across internal manufacturing and external suppliers . This role ensures analytical methods, specifications, and data packages are scientifically sound, phase‑appropriate, and compliant with global regulatory expectations. The contractor partners closely with QA, ASAT and external labs to drive analytical readiness for GMP tech transfers and validation batches. This contract position reports into the Tech Transfer & Validation Quality organization and is expected to operate with a high degree of independence, technical rigor, and cross‑functional collaboration. KEY DUTIES AND RESPONSIBILITIES: - Review and approve analytical methods, method validation/verification protocols and reports, and method lifecycle documentation to ensure scientific robustness and regulatory alignment - Assess analytical readiness for process validation, PPQ, comparability studies, and tech transfer activities - Evaluate specifications, stability-indicating methods, and critical quality attribute (CQA...