Senior Manager, Corporate Audit

Summary The Senior Manager – GCP Auditor is responsible for planning, leading and conducting Good Clinical Practice (GCP) independent audits and risk oversight activities. These audits/activities provide an independent assessment of the design and operating effectiveness of controls and compliance with appropriate GCP regulations, industry standards, internal policies and procedures and good business practices. Additionally, this individual interfaces with business representatives and makes recommendations on oversight approaches for risk mitigation.

Responsibilities 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 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, to support controls testing as appropriate. Manages the appropriate prioritization of work to execute an effective work plan for audit/project work and keeps Audit Director regularly apprised of status and issues. Analyzes large data sets to identify potential risks and discrepancies. Provides clear and concise verbal and written communication of audit findings and to senior site and division management, including practical recommendations to address identified risks, requiring strong negotiation and influence skills. Documents audit work and prepares formal written reports setting forth recommendations for local, division and corporate management to strengthen and improve operations. Conducts or supports other oversight activities (e.g., Assessments, compliance investigations) as assigned. Identifies ways to improve audit processes to ensure appropriate assessments of controls in an evolving business model. Analysis 1. Recommends approaches for oversight activities to mitigate risks across the assigned business line. 2. Identifies ways to improve oversight and assessment processes. Relationship Management 1. Works within functional area to ensure consistency in approach and to minimize gaps and redundancies in activities. 2. Cultivates strong relationships within Corporate Audit to achieve an effective oversight program. 3. Uses compliance and business intelligence to forge relationships critical to a comprehensive oversight program. Other Activities 1. Maintains high level of awareness of changing needs of the business, industry trends, competitive activities, and regulatory environment. 2. Takes on special projects at the request of management. 3. Serves on Corporate Audit departmental committees/teams, as necessary. 4. Assists in the development/updating of Corporate Audit departmental standard operating and administrative procedures. 5. Serves as a resource on GCP compliance matters for their area of subject matter expertise. Skills, Qualifications and Experience Bachelor's degree, preferably in an area such as Biology, Chemistry, Nursing, Medical Technology, Pharmacy, or health. 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. A 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. Ability to assess systems and processes in a highly systematic manner and make conclusions based on sound judgment and experience to identify gaps and potential risk. Strong analytical skills with the ability to digest and interpret complex data. Ability to rapidly comprehend