Analytical Quality Assurance Manager (contract) 28373
About The Position
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.
Requirements
- Bachelor’s, Master’s, or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline
- 5+ years of experience in analytical development, QC, or analytical QA within the pharmaceutical/biotech industry
- Strong understanding of analytical method validation, method lifecycle, CMC expectations, and ICH guidelines
- Experience supporting tech transfer or process validation (PPQ) readiness activities
- Demonstrated ability to review complex analytical data and technical reports with scientific rigor
- Ability to operate independently in a contractor capacity while maintaining alignment with internal quality systems.
- Experience with electronic document management systems (e.g., Veeva)
Nice To Haves
- Experience working with CTLs, CMOs, or external partners strongly preferred
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) linkages to ensure appropriate control strategies
- Provide technical review of analytical data packages, including release, stability, characterization, and comparability datasets
- Serve as the analytical SME on tech transfer and validation teams, ensuring analytical deliverables are identified, risk‑assessed, and executed on schedule
- Support analytical readiness for PPQ, including method performance, sample plans, data trending, and acceptance criteria alignment
- Review validation protocols, master validation plans, and technical reports with a focus on analytical inputs and outputs
- Partner with ASAT and external labs to resolve analytical issues impacting validation or transfer timelines
- Review and approve change controls related to analytical methods, specifications, reference standards, and laboratory systems
- Support investigations, deviations, OOS/OOT events, and CAPAs involving analytical methods or data integrity
- Ensure compliance with GMP, ICH, and regulatory expectations for analytical method lifecycle and validation
- Contribute to inspection readiness activities, including analytical storyboards, data traceability, and SME preparation
- Provide QA/analytical oversight for contract testing labs (CTLs) and CMOs performing analytical work
- Review and align on analytical method transfer packages, sample management, and data review expectations
- Monitor performance, communication pathways, and issue escalation for external partners
- Identify analytical risks related to method robustness, sample management, data integrity, and validation readiness; drive mitigation strategies
- Support continuous improvement initiatives across analytical quality, method lifecycle management, and tech transfer processes
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What This Job Offers
Career Level
Manager
Education Level
Ph.D. or professional degree
