Associate Director, Quality Assurance

Job Description Our Research & Development Division QA Clinical Quality (CQ) provides independent assurance that our Company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials.

Primary Responsibilities:

Prepares, conducts QA audits, including prolonged auditing in China, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.

Collaborate with colleagues in China to understand cultural considerations, responsibilities for work in global studies and local regulations in the China related to GCP and new drug applications.

Able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risk-based audits.

GCP routine and directed audits of investigator sites, country offices, suppliers, , third party collaborations and due diligence  alignment with risk assessments and input from Japan/China Lead, support the QALs in the identification of audit substrate in China for scheduling, as appropriate.

Ability to travel to/within China; extended stay in country (2-3 weeks per quarter).Travel: 75% - Asia Pacific (China), including ROW as needed.

Preferred:

Facilitates communication and alignment with key stakeholders related to quality events and audit findings.

Participate in Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as deemed appropriate by the QAL.Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.

Skills:

Influence/Negotiation
- Using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.

Ownership and Accountability
- Taking ownership; setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.

Execution Excellence
- Taking prompt action to accomplish work goals, per compliance standards; taking action to achieve results beyond what is required; being proactive.

Networking and Partnerships
- Building partnerships; developing and leveraging relationships within and across work groups to achieve results.

Coaching and Development
- Building self-insight; demonstrating an awareness of own strengths and development needs as well as the impact of own behavior on others; modifying behavior based on self-awareness to improve impact.

Talent Growth
- Embracing continuous learning; actively identifying new areas for growth; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skills on the job and learning through their application.

Education:

Bachelor's degree (BS/BA) or equivalent preferred.

Minimum of 5 years of experience in a relevant field.#eligibleforERP

Required Skills:

Accountability, Accountability, Action Plan Development, Adaptability, Audit Management, Building Partnerships, Compliance Investigations, Deviation Management, Global Program Development, Impact Analysis, Influencing Skills, Proactive Behavior, Proactive Thinking, Project Leadership, Project Risk Assessments, Quality Assurance Processes, Quality Assurance Systems, Quality Auditing, Quality Oversight, Quality Reporting, Quality Risk Management, Quality Systems Compliance, Regulatory Compliance, Results-Oriented, Setting Performance Standards {+ 2 more}Preferred

Skills:

Current Employees apply HERE Current Contingent Workers apply HEREUS and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin,…