Associate QA Operations Director- Computer Systems and Data Integrity

Role Summary

This Associate Director, Computer Systems and Data Integrity (DI) is accountable for driving a risk based, comprehensive implementation of the DI program meeting cGxP regulations, and responsible for Computer System Validation (CSV) oversight by setting and maintaining a company strategy, QA oversight, evaluating CSV regulatory landscape and revising company policies and procedures accordingly. Works cross functionally to establish, implement and report metrics to measure compliance and continuous improvement, assess, resolve and/or escalate CSV/DI issues and associated risks. Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality, for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions, internally or externally, and QA, to provide and ensure delivery on company core goals and pipeline deliverables.

Responsibilities

• Responsible for generating a risk-based strategy across the GxP landscape that identifies and manages issues and risks while driving continuous improvement to ensure continuous compliance to global DI standards and aligning with key stakeholders.
• Reviews and approves validation deliverables (URS, FS, IQ/OQ/PQ, etc.).
• Monitors emerging regulatory health authority requirements for GxP computerized systems, process controls, and compliance for data creation and handling, and ensures that procedures are revised accordingly
• Team player and driver, identifies KPIs, sets metrics and success criteria
• Identifies, mitigates, escalates and resolves issues and risks
• Authors and review CSV, DI policies, procedures, lifecycle documents
• SME for Health Authority inspections and audits
• Delivers CSV/DI training as required
• Responsible for establishing and maintaining a program compliant with Title 21 CFR Part 11 for systems used to generate, modify, maintain, archive, retrieve, or transmit GxP data.
• Understands global Health Authority regulations and guidance as it pertains to computer system requirements and provide guidance.
• Provides QA support for all Exelixis GxP Computer systems and platforms
• Establishes strong collaborative relationships with internal and external stakeholders to ensure timely documentation, escalation and resolution of quality issues

Qualifications

• BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 11 years of related experience; or
• MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 9 years of related experience; or
• Equivalent combination of education and applicable experience.
• Significant management experience within the pharmaceutical and biotech industries required
• Oncology experience is required.
• Experience in Portfolio, Project and/or Alliance Management.
• Experience using standard data querying and management tools including SAS or SQL.

Skills

• Thorough knowledge and understanding of drug development process, GxP Global Regulatory Requirements and regulations related to DI/CSV.
• Proven ability to manage multiple competing priorities, evaluate data to detect weak signals, blind spots and rapidly escalate cumulative risks.
• Demonstrated ability to lead through change by engaging others, assessing unforeseen situations, continuously learning to achieve a goal, and drive for results.
• Excellent written, verbal and presentation communication skills, able to translate and communicate complex concepts across all levels of the organization.
• Successfully engages and collaborates effectively with cross functional teams.
• Proven ability to interpret and analyze data, provide feasible and effective technical solutions.
• Applies strong analytical thinking to develop technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.

Education

• As listed in Qualifications (above).

Additional Requirements

• Travel as required 5-10% of time