Astellas Pharma Director, Business Governance & Quality Process in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Director, Business Governance & Quality Process opportunity in Northbrook, IL.
Purpose & Scope:
The Director, Business Governance & Quality Process, is responsible for establishing, managing and optimizing the quality and risk management resources (policies, SOPs, WPDs, and tools) with a focus on operational efficiency for all regions of Astellas' AIA function and aligning these with Astellas global and regional policies and global relevant laws and regulations. This individual champions achievement of quality and risk management objectives for AIA core work and its global strategic initiatives. It advises and collaborates with AIA operating leaders so they understand and act to meet their quality and risk management obligations. This role is the primary liaison with Astellas' risk expert groups and uses its relationships to bring specialized advice and judgement to AIA when needed
Essential Job Responsibilities:
Acts as the key AIA resource for coordination with business partners, in global functions related to legal, pharmacovigilance, quality, privacy, ethics, and compliance activities:
- Leads Business Governance & Quality Process activities on critical project teams for AIA division and corporate strategy activities.
- Drives alignment of AIA's quality, compliance, and privacy activities with internal expert functions, other business partners, and external advisors.
- Works proactively with AIA's other group leaders to incorporate appropriate quality and privacy processes and controls into AIA's analytic and reporting offerings.
- Operates cross-functionally with E&C and Legal to address privacy and process concerns with secondary use and other data containing sensitive information.
- Leads development and implementation of operational controls, policies, and procedures governing the secondary use of data and other sensitive data: compliance with internal company-level and external laws and regulations.
- Defines, implements, and maintains monitoring capabilities for AIA operations regarding safeguarding of information.
- Coordinates with Astellas risk experts to incorporate changes to laws, regulations, and guidance into AIA's quality system.
- Coordinates training to users of data and analytics in global functions (e.g. HEOR and strategic marketing) using sensitive data (e.g. RWD), analytics, and services regarding AIA-specific policies, SOPs and WPDs regarding patient privacy, abuse / misuse, pharmacovigilance, etc.
- Creates, implements, and maintains training programs and certifications necessary for adherence to AIA policies, SOPs and WPDs that AIA personnel and internal and external business partners must adhere to.
- Designs, implements, and maintains internal self-monitoring program for the AIA division, internal Astellas users and external partners for controls embedded in AIA-specific SOPs and WPDs.
- Primary contact for internal and external audits of AIA systems and for compliance and regulatory requests. Coordinates audit and inquiry response activity with the AIA team members.
- Advises AIA's Operations and Informatics Teams to align AIA information systems and data management controls with other processes and controls, both internal to AIA and across Astellas.
- Drives efforts with AIA Informatics and Operations Teams on identifying and implementing technical solutions having a Business Governance & Quality Processes component and leads project portions related to compliance and risk.
This position will have significant influence on the day-to-day operations of the AIA function -- managing and optimizing the entirety of the quality document pyramid (SOPs, WPDs) along with supporting tools and other quality and control mechanisms of the group (e.g., self-monitoring schema).
- Direct reports: 2
- May coordinate small group of contract resources (2-3).
- This position reports directly to Astellas Senior Director, Head of Informatics & Operations.
- BA/BS in Accounting, Business Management
- 10-15 years relevant experience; minimum of 5 years previous experience in pharmaceutical or life science industry with experience in data analytics and informatics, Compliance and/or Internal Audit
- Strong process management and controls skills
- Practical experience assessing risk and implementing efficient mitigating controls (direct or indirect) across multiple data types, use cases, and business processes.
- Detail-orientated with strong problem solving skills. Ability to visualize problems, ask the right questions and find the right inputs
- Must be able to efficiently educate business partners across the Astellas regions on risk and controls in relation to data used for secondary uses and privacy and security concerns of such data
- Credible to contribute to ongoing drug development, medical affairs, health economics and epidemiology projects in value-added manner
- Poise, confidence, adaptability and effective influencing skills needed for interacting with Astellas leaders in challenging situations.
- Excellent verbal and written communication skills with proven ability to tailor message to various audiences
- Strong organizational and analytical skill, with a proven track records for managing through diverse and challenging situations
- Proven work experience in execution of collaboration skills with stakeholders across the company
- Demonstrated ability to work across regions and divisions to bring together individuals with different perspectives and opinions, and drive toward a common goal
- Legal and/or compliance background Previous experience with IT auditing
- Previous experience with real-world informatics and sensitive data and functions
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Advanced Informatics & Analytics