Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
This role is actively involved in ensuring that SAP Systems implemented and managed by Astellas IS comply with regulations (GxP, JSOX, Data Protection etc.), Astellas Policies and Standards.
Essential Job Responsibilities:
Risk & Compliance
* Develop a global SAP Compliance team and provide compliance leadership to project and BAU change teams implementing and maintaining SAP systems. This includes overseeing interim R&C resources who review and approve SLC deliverables.
* Ensure that the necessary technical and procedural controls and risk mitigations for SAP systems are appropriate, effective and monitored.
* Lead the oversight of service providers and other third parties to ensure compliance with regulations and Astellas policies and standards. This includes supplier assessments as required.
* Partner with IS SAP leadership and develop and maintain strong relationships with other Astellas stakeholders including Business functions, QA, M&D, Cyber Security, Compliance groups, manufacturing plants and the affiliates.
* Work closely with IS R&C colleagues responsible for supporting CCP, RDP and JSOX and Financial Governance.
* Embed a culture across all regions and functions to encourage a proactive approach to all aspects of compliance.
* Support the development, maintenance, training and usage of the global IS Quality Framework processes and materials to support quality and compliance.
* Oversee the effective management of SAP related Risks, Deviations and CAPAs.
* Initiate process and quality improvement initiatives.
* Support internal audits and periodic reviews of Astellas IS and assist in the resolution of observations.
* Assist the IS Risk & Compliance team in the effective coordination of responses to audit observations (internal and external), including inspections by regulatory bodies (e.g. MHRA, FDA, EMA).
* Reports to: Associate Director IS Risk & Compliance
* Peers: Managers, Senior Managers, Associate Directors in IS
* Directors, Associate Directors, Senior Managers in QA
* Reports: No direct or indirect reports
* Bachelor's Degree in Computer Science, related field, or equivalent experience required.
* Strong SLC / Validation / Compliance background with good GAMP experience especially with SAP ECC, S/4 Hana.
* Analytical approach to problem solving and able to suggest pragmatic options.
* Must exhibit creativity and innovation in solutions; be broadly focused and able to manage multiple efforts concurrently.
* Exceptional attention to details and ability to consistently produce high quality and accurate work.
* Has solid interpersonal and communications skills (written, oral, and non-verbal) to effectively relate to global colleagues, technical staff and business customers.
* Good persuasion skills and the ability to make judgements in accordance with compliance risks. To ensure that Astellas compliance posture is not compromised
* Ability to be self-directed within the scope of their duties and responsibilities.
* Experience in managing vendor resources.
* Knowledge of IS Security, SOX / JSOX and Data Privacy regulations
* Familiarity with IS Audit processes
* Experience with IS Communications
* Working knowledge of electronic document or change management systems.
* Experience of applications such as ERP systems, CRM, LIMS, MES or CTM.
* Considerable practical experience related to change and configuration management in a pharmaceutical environment.
* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
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