Job Description

The Contract, Quality Assurance - GLP is responsible for 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. They may manage direct reports. The incumbent is responsible for QA oversight and support of an in-house GLP / GLCP bioanalytical laboratory, and outsourced bioanalytical and toxicology studies. The Contract, Quality Assurance – GLP supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. ESSENTIAL FUNCTIONS: 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 manage, coach, and mentor junior staff. Performs other tasks and assignments as needed and specified by management. KNOWLEDGE/SKILLS/ABILITIES REQUIRED: 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. Detailed knowledge and understanding of FDA GLP (21 CFR Part 58) and OECD regulations. Demonstrated experience leading and/or conducting QA audits. Demonstrated experience developing and executing risk-based audit plans. Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors. Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports. Ability to influence without direct authority. Experience supporting regulatory agency inspections. Proficiency with Microsoft Office. Excellent verbal and written communication and skills. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects. Special knowledge or skills and/or licenses or certificates preferred: Experience writing and reviewing SOPs. Bioanalytical lab experience and toxicology auditing. Registered GxP Quality Assurance Certifications. 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. Travel up to 30%. Hybrid based position with office in Hopewell, NJ.

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