Associate GCP/GLP QA Director

Role Summary

This key role drives consistency across QA systems and processes for the Clinical QA team, identifying issues and risks, escalating in a timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs. This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality Management (OQM) to address day-to-day clinical trial operations activities focused on deviations, investigations, audit findings and CAPAs. This role operates across all the Clinical project teams and provides training with inspection readiness activities as required.

Responsibilities

• Responsible for designing and coordinating a comprehensive view and aligning standards on Quality systems across Clinical Quality Assurance.
• Assesses current state, identifies gaps, develops an action plan, implements improvements, and monitors the Quality Systems and internal processes related to GCP QA activities
• Develops, tracks, and manages periodic management reports focused on track and trend data for key Clinical and QA metrics driving the quality health of the GCP activities.
• Reviews and approves Deviations, and Corrective and Preventive Actions (CAPAs)
• Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance
• Maintains knowledge of current Health Authority regulations and standards and informs Clinical Development stakeholders of potential impact on the organization
• Represents CQA in internal presentations on quality issues, initiatives, and projects
• Identifies issues and risks and proposes options and solutions, escalating risks in a timely manner.
• Participates in identifying and implementing process and system improvements

Education/Experience

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

• Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 11 years of relevant experience; or,
• Master’s degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of relevant experience; or,
• PhD degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 5 years of relevant experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal For Successful Entry Into Job

• Minimum of 10 years relevant experience in pharmaceutical and biotech industries.
• Experience in Good Clinical Practices highly desired
• Demonstrated experience in Quality Systems including critical analysis of impact and continuous improvement processes
• Strong understanding of Quality Risk Management
• Experience using standard MS Office

Knowledge/Skills

• Understanding of the drug development process, particularly related to QA oversight of clinical trials
• Experience in assisting in the development of business strategies, metrics, and continuous improvements
• Working knowledge of Health Authority rules and regulations
• Proven ability to manage Quality Systems, assuring completeness and acceptability as defined for GCP.
• Ability to apply Quality Risk Management in a variety of situations across Quality Systems
• Ability to influence others as part of a collaborative team and negotiate effective solutions
• Strong interpersonal and social skills
• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
• Detail-oriented in execution of tasks and processes
• Implements technical solutions within quality requirements to complex problems.
• Excellent verbal and written communication skills
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Provides insight and analysis of situations or data requires a review of a variety of factors.

Working Conditions

• Environment: primarily working in laboratories or in office
• Infrequent travel may be required.