AddressDescription
MUST be on-site 2-3x per week in Pennington (Hopewell)
6-month contract (potential for extension/conversion).
The Contract, Quality Assurance - GLP is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Laboratory Practice (GLP), and 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.
She/He may manage direct reports.
The incumbent is responsible for QA oversight and support of an in-house GLP 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 GLP 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 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.
Preferred
- Experience writing and reviewing SOPs
- Bioanalytical lab experience.
- 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.
