Senior Manager, GCP Auditor, Research, Development & Supply (RDS)

The Senior Manager, GCP Auditor, Research, Development & Supply (RDS) is responsible for planning, leading, and conducting Good Clinical Practice (GCP) independent audits and risk oversight activities.

These audits provide an independent assessment of the design and operating effectiveness of controls and compliance with appropriate GCP regulations, industry standards, internal policies, and procedures, as well as good business practices.

Audits

• Provides fact-based input into the risk assessment of audit targets and leads/conducts scheduled audits in accordance with Corporate Audit processes.
• Analyzes risk information, applying critical thinking, and demonstrates a high level of learning agility.
• Adapts audit methodologies across a broad set of risks to develop customized audit plans.
• Collaborates with the Audit Director and the Analytics and Innovation team to develop an audit plan, including data analytics where applicable.
• Manages the prioritization of work to execute an effective work plan for audit/project work.
• Analyzes large data sets to identify potential risks and discrepancies.
• Provides clear and concise verbal and written communication of audit findings and recommendations to senior site and division management.
• Documents audit work and prepares formal written reports setting forth recommendations for local, division, and corporate management.

Analysis

• Recommends approaches for oversight activities to mitigate risks across the assigned business line.
• Identifies ways to improve oversight and assessment processes.

Relationship Management

• Works within the functional area to ensure consistency in approach and minimize gaps and redundancies in activities.
• Cultivates strong relationships within Corporate Audit to achieve an effective oversight program.
• Uses compliance and business intelligence to forge relationships critical to a comprehensive oversight program.

Other Activities

• Maintains a high level of awareness of changing business needs, industry trends, competitive activities, and regulatory environment.
• Takes on special projects at the request of management.
• Serves on Corporate Audit departmental committees/teams as necessary.
• Assists in developing/updating Corporate Audit departmental standard operating and administrative procedures.
• Serves as a resource on GCP compliance matters for their area of subject matter expertise.

Requirements:

• Bachelor's degree, preferably in Biology, Chemistry, Nursing, Medical Technology, Pharmacy, or health-related fields. Advanced degree preferred.
• Ten or more years of relevant GCP International operational experience in clinical development required.
• Five years' experience in GCP quality-related compliance discipline.
• Thorough understanding and extensive knowledge of ICH GCP and applicable global & local regulations/guidance for clinical development.
• Previous experience in GCP risk assessment and/or analysis strongly preferred.
• Demonstrated ability to apply knowledge of regulations, policies, and standards to assess compliance.
• Strong analytical skills with the ability to digest and interpret complex data.
• Excellent written and verbal communication and presentation skills.
• Proven leadership skills.
• Ability to travel (domestic and international) to around 15-20%.