Associate Director – Quality Assurance

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Execute and oversee QA audits, which may include extended auditing in China.

• Create audit reports and share findings with QA management and pertinent external stakeholders.

• Collaborate with teams to ensure that corrective and preventative measures address QA observations.

• Work alongside colleagues in China to consider cultural factors, global study responsibilities, and local GCP and new drug application regulations.

• Recognize potential risks and prepare as well as conduct risk-based audits utilizing critical-to-quality factors.

• Perform GCP audits of investigator sites, country offices, suppliers, third-party collaborations, and due diligence activities.

• Assist in identifying and scheduling audit substrates in China in accordance with risk assessments and input from Japan/China Lead.

• Enhance communication and alignment with stakeholders concerning quality events and audit outcomes.

• Engage in the management of Significant Quality Issues, including root-cause analysis and remediation efforts.

• Report quality concerns, potential misconduct, and significant deviations to the QAL and TA Head.

⛳️ Requirements

• A Bachelor’s degree (BS/BA) or equivalent is preferred.

• At least 5 years of experience in a relevant discipline.

• Proven experience in conducting GCP routine and directed audits.

• Proficient in auditing investigator sites, country offices, suppliers, third-party collaborations, and due diligence activities.

• Capability to analyze critical-to-quality factors and perform risk-based audits.

• Willingness to travel to/within China, including extended stays of 2–3 weeks per quarter.

• Travel requirement of 75% within Asia Pacific (China), including other regions as necessary.

• Knowledge of quality assurance, quality auditing, quality systems, and regulatory compliance.

• Skills in audit management and quality risk management.

• Competence in project risk assessment and action plan development.

• No visa sponsorship available.

• Applicants must be residents of the US or Puerto Rico.

• A valid driving license is not required.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical healthcare benefits for employees and their families.

• Dental healthcare benefits for employees and their families.

• Vision healthcare benefits for employees and their families.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate leave.

• Sick days.

• Remote work arrangements.