Manager Quality Assurance Bioanalytical Research

Title: Manager Quality Assurance-Bioanalytical Research
Duration: 06 Months-Contract to Hire
Location: Pennington, NJ, 08534

JOB DESCRIPTION:

The Manager, Quality Assurance - GLP is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Laboratory Practice (GLP), compliance for development products. This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate.

The incumbent is responsible for QA oversight and support of an in-house GLP bioanalytical laboratory and outsourced bioanalytical and toxicology studies.

The Manager, Quality Assurance - GLP supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities:

Partners with Preclinical Development Drug Metabolism and Pharmacokinetics (DMPK) and Toxicology departments to ensure GLP compliance. Reviews and approves study-related documents and plans including method development, method validation, and study data.
Performs internal and external audits as assigned to assure compliance with GxP regulations and guidelines including in-phase study, internal processes, data, regulatory filings, and vendors)
Communicates audit results to internal stakeholders and writes audit report.
Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs).
Participates in regulatory authority inspections and assists with GxP inspection readiness activities.
May coach, mentor junior staff or manage others.
Performs other tasks and assignments as needed and specified by management.
Required Skillset:

This Candidate must have a background in the following

Detailed knowledge and understanding of GLP and OECD regulations.
Bachelor's degree in a scientific discipline and a minimum of 6 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment.
Leading and conducting QA Audit (internal & external)
Proficiency with Microsoft Office.
Would Stand Out:

Registered GxP Quality Assurance Certifications
Experience writing and reviewing SOPs
Bioanalytical lab experience.
Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections.
Knowledge and experience in Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and/or Good Pharmacovigilance Practice (GVP) regulations.
CSQA Certification
Employment Type: Other
Salary: $ 65.00 72.00 Per Hour