Compliance Audit Specialist

Job Category: Quality Assurance/Safety Career Level: Experienced (Non-Manager) Our CultureAt Boehringer Ingelheim, we deliver Value through Innovation by living our fundamental principles of Lead & Learn. We have high expectations for our employees. We require employees at all levels of the organization to take initiative, stay connected, grow together, and achieve outstanding results. To enable high performance, we provide opportunities for personal growth, a collaborative and inclusive work environment, and exceptional employee benefits. We reward high achievement with recognition, opportunities and competitive pay. We hold ourselves to the highest standard of excellence and count on each other to go the extra mile in everything we do. Compliance Audit Specialist Description of Duties: Plan and execute compliance audits in support of supplier qualification and internal compliance and determine the degree of compliance of areas/suppliers audited. Participate in regulatory audit host team. Remain up-to-date on regulatory guidelines and BI corporate policy to ensure BVL compliance with these requirements. Work with audited areas/suppliers to identify appropriate corrective and preventive actions (CAPA). Perform CAPA follow up through written confirmation or on-site verification to ensure timely closure of corrective action commitments. As Lead Auditor, provide training and oversight for co-auditors and trainees. 10-20% travel. Qualifications/Experience: Requires a BA/BS degree in life sciences, engineering, or related discipline. Certified Quality Engineer and/or Certified Quality Auditor certifications (i.e., ISO or ASQ) highly desirable. Must possess excellent interpersonal and written communication skills, sound judgment and analytical skills to enable assessment of risk. Requires at least 3 years experience in the pharmaceutical industry, including conducting internal and/or supplier audits. Technical field of expertise highly preferred; work experience in validation, process engineering, aseptic manufacturing, or analytical chemistry a plus. Must have a good working knowledge of standard business software packages (Microsoft preferred). Demonstrated project management skills desirable.  Corporate Site