407411 Senior Director, Data & Digital, Quality Business Partner

Direct accountability for developing and implementing quality strategy to oversee data quality:

Oversees the incorporation of new technology and innovation (Biostatistics, Digital Health, Data Management, eConsent, eMedical records, eCOA) in drug development.

Oversees the development and implementation of digitalization strategy.

Engage with management and cross functional business partner to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement.

Considered a strong trusted partner with R&D and Tech leaders; consulting with those stakeholders to understand needs and determine priorities.

Support the business in ensuring quality by design and to enable the execution of external regulations, guidance and internal standards.

Works with QuRE data analytics team to define KPI, KQI and metrics needed for QuRE and stakeholders.

Provide input into global audit plan based on identified signals/trends/risk/gaps.

Represents QuRE in committees and governance meetings.

Ensures ongoing inspection readiness in the area of responsibility and implements required activities, supporting the preparation, execution and close out of inspections.

Provide quality advice and GxP validation expertise within the functional & process area.

Ensures rapid communication of critical quality issues and risks including potential misconduct to appropriate business partners and leaders.

Supports the investigation of potential serious breaches and critical issues.

Participate in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT.

May influence the external environment through interactions with regulators, trade associations, and professional societies.