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Job Description

About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare
diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a
team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a
fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

OBJECTIVES/PURPOSE

The BioLife Data and Documentation Control (DDC) team is responsible for ensuring documents and records are managed within compliance to applicable regulations and company procedures.

They oversee these processes for BioLife U.S. Centers and Headquarters personnel.

They are responsible for the continual improvement of these processes and work with key stakeholders across the company, including:  BioLife operations, BioLife Quality, BioLife project teams, BioLife Training, global Takeda process owners, global teams, global communities of practice, BioLife service providers and suppliers.

ACCOUNTABILITIES

• Oversight of document and record lifecycle activities (creation, revision, periodic review, storage and destruction)
• Qualify and manage approved service providers (including payments for services and issue resolution)
• Provide training, coaching and access to the global document management system
• Establish and enforce processes to comply with data integrity requirements for documents and records
• Manage the Signature Log and Delegation processes
• Own and manage the protocol and white paper processes
• Oversight of process change controls
• Lead and support BioLife growth and improvement initiatives
• Subject matter expert for data and documentation management activities for regulatory and internal inspections
• Subject matter expert for data and documentation management activities related issues and mitigations
•  Procure, assess, test, and provide insight on new technologies being pursued by BioLife
•  Monitor and report on performance execution of data and document control processes
•  Assist with Takeda Integration activities, and provide cross functional support for NAT/BOL process, Donor Reinstatement documentation, New Center Installation validations, etc.

DIMENSIONS AND ASPECTS

Leadership

• Ability to drive decisions through influence
• Self-motivated
• Strong communication skills (written and oral)
• Team oriented
• Ability to manage, prioritize and deliver on core responsibilities

Decision-making and Autonomy

• Ability to identify and resolve problems as they arise
• Ability to understand the risks and benefits surrounding decisions

Interaction

• Customer focus – willingness to help, respectful, prompt and accountable
• Partners with BioLife Quality and Center Operations

Innovation

• Open to new ideas
• Embraces change
• Confidence in challenging the status quo

Complexity

• Ability to thrive in a dynamic setting
• Ability to break down complex situations into manageable pieces
• Ability to understand upstream and downstream impact of decisions

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential

• 5 + years of experience with data management/documentation systems or equivalent Change Control
• GED or Associates Degree
• Experience within a regulated industry and knowledge of Quality business systems

Desired

• Understanding of plasma collection business and associated regulations
• Strong knowledge of GMP's
• Proficient in Microsoft tools:  Teams, Excel, Word, PowerPoint, and SharePoint
• Experience in technical and procedure writing & leading cross-functional teams
• Ability to handle multiple projects at one time with strong attention to detail

Locations

Bannockburn, IL

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time