Job Title: Analytical Sciences Quality Lead

Job Type: W-2 Contract

Duration: 12 months

Location: New Haven, CT 60% Onsite

Position Summary

Our client is seeking an Analytical Sciences Quality Lead who will provide Quality partnership and oversight of internal /external testing, stability, analytical technical transfer and quality systems elements in a matrix environment. 

Principal Responsibilities

·        Review of technical documents, analytical method validation and transfers for Phase I to III clinical products (including but not limited to biologics, synthetics, cell & gene therapy as well as combination products)

·        Quality oversight of assay validation and transfer programs internally and externally

·        Review and approval of stability reports, analytical development, equipment qualification reports and verification reports.

·        Perform data verification on CMC sections for filings based on technical reports.

·        Partner with ADQC and PDCS Compliance team to manage the timely completion of QMS records (Change Controls, Deviations, LIRs and CAPA’s) aligned to Global quality metrics goals.

·        Proactively manage clinical product quality risks ensuring they are appropriately mitigated, actioned

·        and escalated to senior management as required.

·        Supports analytical lifecycle management initiatives

·        Partner with other Quality colleagues on product quality impact assessments,

·        particularly for notifications to management, recalls, etc.

Qualifications

·        Preferable 8 years or more cGMP experience within quality assurance in a biotech, pharmaceutical, or biopharmaceutical manufacturing environment, clinical phases through commercial

·        Prior experience with method validation and method transfers

·        Strong analytical background

·        Demonstrated ability in decision making, problem solving and project management.

·        Collaborate, negotiate, influence and lead in a matrix organization

·        Excellent communication and interpersonal skills

·        Knowledge of quality systems with a strong technical acumen required.

Education

·        B.Sc./MS degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry.