at Takeda Pharmaceuticals in Montpelier, Vermont, United States
Job Title: Documentation Manager / Principal Archivist
Location : Remote
About the role:
+ The purpose of this role is to provide global leadership and ensure consistent execution of assigned key processes owned by Quality (examples include, but not limited to Documentation and Training and Records Management.
+ Documentation Manager is accountable for the development, deployment, maintenance, and continuous improvement of assigned processes, including procedures, practices and standardized global training materials.
+ Documentation Manager will ensure that process requirements are effectively deployed in interdependent processes, projects, and/or initiatives.
+ Fill role of Takeda’s Principal Archivist as the key point of contact for assigned processes as well as Program, Project, or Workstream Lead on cross-functional teams. Accountable for implementation of global programs and contributions to the project delivery for cross-functional projects.
How you will contribute:
+ Responsible for ownership of assigned global procedures and has the oversight for implementation in close cooperation with system owner.
+ Maintain global procedure(s), and training materials in compliance with Global cGMP requirements and Takeda´s Global Quality Standards (GQS) and Quality Management System (QMS).
+ Support deployment of global process and daily operations as needed by close cooperation with functional Quality Compliance and Systems and site execution leads. Provide training, support and coaching as required.
+ As the Principal Archivist, develop and implement QMS procedures to lead and set strategy for GxP functions to ensure compliance, data integrity, business execution with global Quality oversight for GLP Archive program ( e.g., records and data per 21CFR Part 58 ). Collaborate to ensure compliance withGlobal Records and Information Management program.
+ Support sites and function during regulatory inspections or customer audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
+ Drive knowledge sharing via Community of Practice (COP), define operating mechanisms, and communication strategies for COP. Actively participate in other Takeda´s knowledge sharing platforms
+ Define process monitoring methods, including data collection and analysis, metrics and associated targets, and reporting mechanisms. This includes both product quality and process effectiveness aspects.
+ Collaborate with other Process Owners and SMEs to drive optimal execution incl. continuous improvement of assigned process across Takeda.
+ Collaborate with Computerized System Owners and SMEs on workflow design, provide end-user input drive optimal design of quality systems.
+ Support DMS system updates and roll out across the Takeda Network
+ Support Local Business System Administrators and Users of the DMS system Globally.
+ Other Duties as required
Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
+ Thorough knowledge of applicable procedures, specifications, regulations and standards, including but not limited too: ISO 9001, ISO 13485, FDA 21 CFR Parts 58, 210, 211, 600, 820, Directive and Guidelines for EU GMP and International GXPs.
+ In-depth knowledge of the regulatory environment for manufacturing of medical products especially the interaction of the global quality processes with the manufacturing process
+ Proven understanding of the pharmaceutical industry and experience in bio-pharmaceutical manufacturing
+ Minimum of 7 years of experience in a role in the biopharmaceutical/pharmaceutical industry (associated with manufacturing operations) and project management experience
+ Strategic thinker with experience in preparing and executing project plans
+ Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships.
+ Demonstrated ability to proactively maximize relationships to enable successful collaboration
Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
+ Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Takeda and drive collaborations with cross-functional teams to accomplish objectives.
+ Independent self-management to work effectively in a fast-paced rapid changing technology environment and to work on multiple work streams and projects simultaneously
+ Lead and routinely demonstrate strong interpersonal skills particularly motivational, negotiation, listening, judgment and conflict management skills as is demonstrated in a matrix global environment.
Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
+ Defines/agrees on the deployment strategies, including the development of project plans if required for the deployment.
Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
+ Key interactions across manufacturing and development network
+ Key focal point for cross functional collaborations internal to Takeda
Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
+ Drive innovation to increase efficiencies with full maintenance of regulatory requirements
+ Drive innovation as Takeda competitive advantage
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
+ Design global procedure(s) in close cooperation with QMS architecture team, based on applicable Takeda standards, national and international regulation to support the broad range of established manufacturing and quality processes.
What you bring to Takeda:
+ BS in science or engineering
+ Knowledge and experience in bio-pharmaceutical technology
+ Ability to lead a team of multi-facility and multi-function employees to a successful outcome
+ Experience must include managing global change by influence – without direct resource control;
+ Strong focus on delivering global results as well as building site capability to demonstrate effective governance
+ Strong interpersonal, communication, influencing, and negotiation
+ Fluent in written and spoken English.
What Takeda can offer you:
+ Comprehensive Healthcare: Medical, Dental, and Vision
+ Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
+ Health & Wellness programs including onsite flu shots and health screenings
+ Generous time off for vacation and the option to purchase additional vacation days
+ Community Outreach Programs and company match of charitable contributions
+ Family Planning Support
+ Professional training and development opportunities
+ Tuition reimbursement
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
+ Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This m