Quality Assurance Associate Director

Quality Assurance Associate Director

Primary activities include but are not limited to:

• Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant business stakeholders (e.g. Clinical trial team), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
• Activities may include GCP and/or PV-related routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third party/business partner collaborations, and due diligence activities.
• Participates in the development/enhancement of QA procedures, guidance documents, and audit tools to ensure QA consistency globally.
• Promotes standardization of auditing approach within QA.
• May represent QA as a single point of contact and provide QA guidance for studies in a certain Therapeutic Area (TA) or in certain countries to achieve continuous quality improvement and effective quality assurance.
• Interfaces with relevant stakeholders, including regulatory, clinical, and development sub-teams, as appropriate to provide Good Clinical Practice/Pharmacovigilance QA expertise.
• Contributes to the QA strategy and supports QA goals for the aligned studies/countries in the Region.
• Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
• In alignment with risk assessments, supports the identification of audit substrates for scheduling, as appropriate.
• In collaboration with the QAL, he actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements) as needed.
• Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as needed.
• Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL, TA Head, and line manager.
• Provides inspection management support as appropriate.
• Develops and delivers awareness sessions with minimal supervision on various GCP and/or PV topics internally and externally.
• Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.
• Routinely suggests new audit techniques/aids in areas of technical expertise
• Design and actively participate in special assignments on various project teams and work streams as determined by QA management.
• Provides training and mentorship to less experienced members of QA staff.
• Ensures the work climate/culture within QA, exemplifies leadership behaviors.

Primary skills include but are not limited to:

• Clinical/Regulatory Expertise: Broad and in-depth knowledge of the drug development process, GCP and GVP guidelines, and applicable regulations is essential.
• Business Acumen/Attention to Detail: Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
• Applied Therapeutic Area knowledge: Familiarity with existing company systems, policies, and procedures and knowledge of multiple therapeutic areas and nonclinical study conduct, including all projects/premier products is desirable.
• Autonomy: Demonstrated ability to work independently
• Logic and analytical skills: Uses rigorous logic and methods to solve difficult problems with effective solutions.
• Communications: Able to communicate complex information and analyses to a variety of scientific and non-scientific audiences in both verbal and written formats in English.
• Leadership: Act independently to make key timely decisions with limited oversight by management. Strong ability to motivate teams to embed quality by design through the life cycle of the project.
• Creative Thinking: Strong ability to operationalize ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking.
• Teamwork: Strong interpersonal skills with the ability to work effectively in teams.
• Influencing: Ability to influence and negotiate with key stakeholders.
• Decision Making: Demonstrates good judgment and decision-making.
• Time Management: Ability to multi-task and manage time efficiently and effectively.