• Responsible for leading, coordination, verification and tracking of global compliance activities within the pharmaceutical division • Evaluation of Investigations and Changes that could have an impact on regulatory commitments • Identification and remediation of plant quality and compliance risks through evaluation of tradition and non-tradition metrics, audit results, gap assessments, etc • Support plant on strategy and compliance plans for identified gaps • Lead/manage working groups to ensure mitigation plans are executed • Responsible for specific preparation of manufacturing sites and I&D Centers for upcoming US-FDA inspections, including but not limited to: Training of plant staff for general inspection aspects and behaviors, as well as specific training for subject matter experts • Performance of mock inspections to evaluate the plants readiness for FDA inspection • Design and deliver need-based training to specific plants in response to identified gaps • Direct participation and support during US-FDA inspections (inspection room and back office), including: Immediate guidance and support during inspections • Support and guidance in preparing response to FDA-483 observations • Independent review of Effectiveness of assigned FDA-483 CAPA • May also include inspections by local authorities when related to Mutual Recognition agreements • Responsible for identification of new FDA cGMP trends and development of strategies to fulfill new expectations • Strategic optimization and harmonization of cGMP and quality related processes to continuously improve pharmaceutical quality and compliance of Fresenius Kabi products • Preparation of global quality management documents (e.g. SOPs, guiding documents, working instructions) • Contribution, execution and management of global projects • Collaborate with other corporate quality functions on the execution of strategic goals • Communicate findings and risks to plant management as well as senior quality management

• Own and continuously improve our GRC program across ISO 27001, SOC 2, ISO 27701, and ISO 42001 • Partner with control owners to make compliance repeatable and low-friction • Drive audit readiness: artifacts, timelines, action tracking, and clear control demonstration • Improve policies, standards, and procedures to reflect actual operations • Build strong working relationships with DevOps/Platform and engineering teams • Evaluate technical implementations and ask good questions • Translate technical reality into clear audit narratives • Contribute to risk identification and assessment • Maintain risk registers and track mitigations • Support leadership reporting by surfacing themes and trends • Evaluate and prepare for future certifications like ISO 22301, HITRUST and FedRAMP

• Drive strategic and innovative pharmacy initiatives with Boards of Pharmacy across your assigned regions • Shape the development and implementation of regulatory and advocacy priorities • Support relationship-building with Boards of Pharmacy, industry coalitions, associations, academic partners, and other external stakeholders • Cultivate cross-functional partnerships across Corporate Affairs, Pharmacy & Consumer Wellness, Legal, and other business units

Role Description Ankura’s Health Care Disputes and Life Sciences Practice advises outside counsel and their clients on a wide variety of legal and regulatory matters. Our practitioners provide expert witness testimony on commercial disputes involving payers and providers, as well as in matters involving False Claims Act, Anti-kickback, Stark, and FDA disputes and investigations. We work with Chief Compliance Officers to build and mature their compliance programs, conduct program effectiveness reviews, and risk assessments, and perform compliance audits. We assist in-house and outside counsel during internal and externally driven investigations through the evaluation of medical records, the determination of medical necessity and appropriate medical coding, and the computation of financial impacts that may lead to repayments. We also provide investigative assistance in matters involving research misconduct, human subjects’ protection, and financial fraud related to research. Our practice is often called upon to advise investors on operational and compliance matters in the course of due diligence. We serve as the Independent Review Organization for many clients and our work product is routinely presented to the Office of Inspector General of HHS and the US Department of Justice. Our clients include academic medical centers, health systems, physician practice groups, post- and sub-acute providers, health plans, pharmacies, and pharmacy benefit management companies, as well as pharmaceutical and medical device manufacturers. This role is location agnostic and may be remote. Responsibilities: - Proficient in medical coding, billing, and documentation requirements - Works with the Project Manager to analyze and understand client concerns and develop project work plans as requested - Understands health care compliance concepts, issues, and how to research and access regulatory guidelines and reference materials - Conducts independent review of medical records - EMR or paper documentation - Drafts clear and concise analyses of medical record review findings - Ensures successful completion of high-quality project deliverables as assigned and within the desired timeframe - Works collaboratively with Ankura team members focusing on building and maintaining internal and external client and counsel relationships - Proven writing and presentation skills - Communicates findings of concern with the team and Project Manager as they are identified - Utilizes creative problem-solving techniques Qualifications - Associate or bachelor’s degree preferred from an accredited college/university - Current Coding Certification through either AAPC or AHIMA - Minimum 10 years health care experience related to clinical documentation, compliance, or coding of medical services - Clinical experience is a plus - Demonstrates excellent communication skills, both written and oral - Experience managing small projects and teams - Familiar with accessing and identifying clinical documentation in electronic medical record systems - Proficient in Excel, Word, and PowerPoint and able to draft reports and presentations and present findings - Ability to problem solve, multi-task, and prioritize assignments - Understands the importance of privileged and confidential communication - Willingness to travel when needed Company Description Ankura is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Equal Employment Opportunity Posters, if you have a disability and believe you need a reasonable accommodation to search for a job opening, submit an online application, or participate in an interview/assessment, please email accommodations@ankura.com or call toll-free +1.312-583-2122. This email and phone number are created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues unrelated to a disability, will not receive a response.