Manager, Clinical Quality Process and Operations Strategy

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 & Scope:

Quality & Process Operations Strategy is a leader in aligning functions across M&D organizations in areas which impact quality and process management. As a Quality & Process Operations Strategy Manager, you will be responsible for providing support for cross-functional quality and process operational initiatives through collaborative partnerships with cross-functional stakeholders.

This position is responsible for supporting quality and process improvement projects within M&D by understanding business processes and cross-functional implications for any requests for process improvement changes. The position is responsible for supporting the development of new processes as well as changes to existing processes. Additional deliverables include writing simplified cross-functional process documents [e.g. policies, standard operating procedures (SOPs), and other working practice or associated guidance documents], and creating process maps based on these documents. This includes applying consistent quality and process model standards, consistently mapping process activities and ensuring integration with all processes in scope.

Essential Job Responsibilities:

• Support enterprise-level initiatives, including facilitating process development activities, effective and efficient process documentation development/revision in Microsoft Word and/or Excel, and process mapping in Microsoft Visio and Casewise/Evolve Business Process Modeling (BPM) software.

• Prepare professional level technical writing deliverables aligned with global documentation standards, Good Clinical Practice (GCP), Quality, Regulatory and Non-Regulatory criteria expectations, and Document Impact Assessments.

• Independently develop/update process maps based on Subject Matter Expert (SME) discussions and/or process documentation within the end-to-end (E2E) Process Model.

• Actively participate in and support facilitation of meetings with functional SMEs to support process document development/revision and process model development/maintenance, and communicate potential documentation/process gaps, as appropriate.

• Support E2E Process Model maintenance in alignment with model architecture standards and incorporation of updates based on identified process changes.

• Support the business in executing process changes to meet quality commitments (e.g., CAPA, inspection/audit findings).

• Participate in quality review activities including, but not limited to, support for tracking and data entry of Development CAPAs .

Quantitative Dimensions:

Responsible for assisting in the evaluation of continuous improvement opportunities to increase compliance with internal SOPs and external GCP regulations.

Organizational Context:

Reports to the Associate Director of Quality & Process Operations Strategy or above. Collaborates with cross-functional peers and subject matter experts to drive quality and process strategies forward.

Qualifications:

Required

• Bachelor's Degree; Master's degree preferred

• Minimum 4 years in the drug development setting (e.g., Clinical Operations, Regulatory Affairs, Pharmacovigilance, Quality Assurance) with a minimum of 2 years leading and/or participating in related process improvement initiatives.

• Two years' experience in process document writing (e.g., Standard Operating Procedures (SOPs)) with demonstrated expertise in related competencies, including AP-style guidance, version control, good document practices and general document control process requirements in the pharmaceutical industry.

• Two years demonstrated experience in process mapping and/or process improvement methodologies (e.g., Lean Six Sigma (LSS).

• Demonstrated understanding of the global drug development processes, quality management principles and standard operating procedures.

• Working knowledge of ICH/GCP regulations.

• Excellent oral and written communication and presentation skills, in English, with an ability to interact at all levels of personnel in a global environment.

• Experience working cross-functionally and cross-culturally in support of quality management and business processes, especially as they impact and influence multiple departments and levels of management.

• Strong analytical and problem-solving skills.

• Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint, Visio, SharePoint).

Preferred

• Experience with continuous process improvement activities

• Working knowledge of Casewise/Evolve BPM software

Benefits

• 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

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Category Medical & Development

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans