The Internal Audit and Risk Manager is responsible providing leadership and management to the internal audit program for identifying risk to GxP compliance and product quality within the PA site operation. This role will also lead and oversee the site Risk management program, providing assurance that both GxP and non-GxP risks are identified, effectively communicated, and mitigated within an appropriate time frame to support the site's objectives.   ~BSP

Position:
* Minimum of 7 years of experience in the Biopharmaceutical/pharmaceutical industry, with at least:
o 5 years of experience working in a GxP site operations (QA/QC preferred)
o 3 years of experience working in direct support of Biologics/Biopharmaceuticals
o 3 years of experience in sterile manufacturing and/or Packaging operations setting   * Advanced skills in planning and executing audits to identify significant risks and non-compliance situations (ASQ or equivalent audit certification is preferred)   * Fully versed in the interpretation and application of cGMP requirements and expectations   * Proficient with risk management processes, tools and standards   * Excellent interpersonal skills, including ability to forge strong relationships and influence others across business disciplines and levels of the organization   * Good verbal and written communications skills   * Working knowledge of Quality Information Systems (e.g., Trackwise) is preferred   * Familiarity with Operational Excellence tools and techniques is preferred.   Education:
Bachelor of Science in biology, chemistry, engineering or related fields is required.   *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation