Corporate Audit, Senior Manager GCP / PV

The Senior Manager - Corporate Audit is responsible for planning and conducting independent audit and risk oversight activities related to the areas of GCP and Pharmacovigilance primarily, as well as GLP, GMP and Animal Welfare. These audits provide an independent assessment of the design and operating effectiveness of controls and compliance with appropriate regulations, internal policies and procedures and good business practices. Additionally, this individual interfaces with business representatives and makes recommendations on oversight approaches for risk mitigation. ROLE RESPONSIBILITIES Audits 1. Provides fact-based input into the risk assessment of audit targets and conducts scheduled audits in accordance with Corporate Audit processes. 2. Conducts other oversight activities (e.g. Assessments, due diligence, compliance investigations) as assigned. 3. 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 or PV compliance matters. QUALIFICATIONS Bachelor's degree in a scientific discipline (e.g. Biology, Chemistry, Nursing, Medical Technology, Pharmacy). Advanced degreepreferred. Five or more years of relevant GCP US and International operational experience in clinical development, and/or Pharmacovigilance experiencerequired. Previous auditexperiencepreferred. A thorough understanding of GCP and/or Pharmacovigilance global regulations and demonstrated subject matter expertise. Demonstrated ability to apply knowledge of regulations, policies and standards to assess compliance. Demonstrated good project management skills. Experience working in dynamic complex business models (e.g. outsourcing and partnerships) Ability to assess systems and processes in a highly systematic manner and make conclusions based on sound judgment and experience in order to identify gaps and potential risk. Excellent written and verbal communication and presentation skills. Excellent interpersonal and negotiation skills, with a demonstrated ability to effectively interact with clients, influence others, identify compliance gaps, and communicate pathways for corrective/preventative actions. Ability to create a strong collaborative environment working with all levels of management. A self-starter who holds themselves and others accountable. Ability to travel (both domestic and international) up to 40%. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS    Travel requirements 40%. 4718920
Salary Range: NA
Minimum Qualification
5 - 7 years

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