Senior Manager, Analytical Quality Assurance

Senior Manager, Analytical Quality Assurance

Contract position – 40 hours per week

Hybrid 2x per week in Brisbane, CA

Position Summary:

Highly motivated QA (Analytical) Senior Manager with experience in Quality Control in support of early/late phase clinical and commercial stage development and production.  The candidate will support CMC Analytical QA activities, while working closely with CMC QA, Analytical Development and CMC Quality Control, and other cross-functional teams in pre-clinical, clinical and commercial biologics and small molecule DS and DP programs.

Responsibilities:

·        Provide QA support of activities related to method development, method validation and transfer studies, method verification of compendial methods, method performance monitoring, specification settings, important reagent and assay standards suitability for continued use, reference standards, trending and stability programs. This includes QA oversight of method lifecycle and documentation (e.g. method development reports, method validation studies, SOPs, important reagent qualification, implementation/maintenance of standards and controls, reference standard qualification, stability protocols/reports, specifications, certificate of testing/analysis) requirements

·        Provide change management and deviation/OOS/OOE/OOT investigation event support

·        Provide QA review of source documentation supporting CMC BLA, INDs, regulatory information requests, and other relevant regulatory dossier sections based on area(s) of expertise

·        Ensure activities and deliverables comply with FDA, EMA and local regulations and guidance, ICH guidelines, client policies, SOPs and industry best practices

·        Other responsibilities as assigned, such as participate in internal discussions to support development of Quality Agreements with contract testing laboratories, root cause analysis and risk assessments

Technical Requirements & Skills:

·        A Bachelor's degree or equivalent work experience in Quality Control or related discipline

·        Minimum of 1 year of experience in QA

·        5+ years of experience in a CBER/CDER regulated industry, with expert knowledge of cGMPs

·        Experience with analytical development and QC (e.g. compendial methods, HPLC, CE, GC, SDS-PAGE, NMR) in support of product lifecycle development from early-phase clinical through commercial

·        Experience managing contract testing labs and CMOs

·        Strong interpersonal skills and the ability to work well as part of a team

·        Ability for systematic thinking

·        Experience establishing quality agreements with contract testing laboratories a plus

·        Experience with application of statistical tools for data analysis/trending a plus

·        Experience in risk assessment and root cause analysis tools a plus

·        Experience with the following software: Microsoft Word, Excel and PowerPoint is required

·        Experience with Veeva electronic quality management system (eQMS) or similar is required