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Stability Project Management Specialist

Job in Lexington - Middlesex County - MA Massachusetts - USA , 02421
Company: Takeda Pharmaceutical Company Ltd
Full Time position
Listed on 2021-04-26
Job specializations:
  • Pharmaceutical
  • Quality Control
    Entry Level Quality Control, Quality Assurance
Job Description & How to Apply Below
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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Stability Project Management Specialist in our Lexington, Mass offices.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission.

As a Stability Project Management Specialist on the Global Stability Compliance Team, a typical day will include:

OBJECTIVES/PURPOSE

* Driving Compliance & Continuous Improvement Projects for the Department.
* Project Management of Process Harmonization and Integration activities.
* Implementing a knowledge management process across all Global Stability products.
* Monitoring the Compliance performance of the Global Stability KPI´s.
* Supporting Stability site Inspection readiness activities and audit support.

Leadership/People:

No. of direct reports: None

ACCOUNTABILITIES

* Project Management of Global Projects for Stability Study Management for Optimization of Stability Programs
* Driving Continuous Improvement Projects and Initiatives for the Department
* Implement a knowledge management process across all Global Stability products.
* Act as Subject Matter Expert for Stability Management Process and Stability Regulations.
* Implement a Regulatory Intelligence initiative for the Global Stability Management Network
* Support the review of Stability Sections for Submissions
* Writing/Review/Approval of Health Authority Requests and Responses to Audits/Inspections.
* Generation, Review and Approval of Global SOPs and Forms for Processes associated with Stability Study Management.
* Supporting all Global Stability Communication Channels ( E-mail, SharePoint, Yammer, Conferences, Workshops, Seminars, CoP, Stability Academy, etc)
* Representation of the department during internal and external Audits and Inspections
* Supporting Stability Community of practice to discuss and align relevant topics.
* Supporting Stability Academy the Stability Technical Training Program.
* Other Responsibilities and Strategical Projects as assigned.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

* Knowledge and experience in Stability
* Experienced in QC related areas
* Experienced in GMP regulations and compliance requirements
* Experienced in providing audit support (either remote or on site)
* Fluent in English (written and oral)

Leadership

* Ability to evolve an organizational structure over time as necessary, and change/adapt the working culture
* Supporting strategic initiatives and improvement projects
* Team Player
* Excellent communication, interpersonal and organizational skills
* Seeks and uses Quality Conversation as an opportunity of improvement.
* Representing Takeda at conferences, workshops, seminars, different platforms, etc. as well as in publications

Decision-making and Autonomy

* Ability to set priorities and to support Global and Local Stability team throughout the network
* Highly flexible and adaptable.
* Ability to make independent decision based on technical expertise.
* Ability to drive for continuous improvement and results-driven analysis of stability issues

Interaction

* Frequent contacts with other areas concerning projects, operational decisions, scheduling requirements, or contractual clarifications. Conducts briefings and technical meetings for internal and external representatives.
* Ability to work both in collaborative teams as well as the capability to influence/negotiate/compromise within cross-functional teams as required to move initiatives forward.
* Interaction with different Health Authorities in the course of inspections as needed

Innovation

* Technical expertise, experience and flexibility to identify opportunities of improvement on stability studies management and share new perspectives and best practices throughout the network with all sites.
* Identifies and organizes innovative ways of communication to best-possible share knowledge throughout the network.
* Conducts work in compliance with cGMPs and regulatory requirements

Complexity

* Works on complex problems in which analysis of situations or data requires and in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Expected to escalate issues as appropriate in a timely fashion.
* Cultural considerations and knowledge of site-specific needs are essential for the successful implementation and maintenance of the different initiatives as well as global procedures

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Education / experience

* A minimum of 6 years of experience in a GMP-Environment in the Pharmaceutical Industry is required
* Typically requires an academic Degree in Science or Engineering (advanced degree preferred) and several years of Experience in pharmaceutical Industry

Core Competencies / Skills

* Experience with Investigational and Commercial trouble shooting
* Experience in different Quality functions
* Experience in supporting global communities

Leadership Behaviors

* Excellent communication, interpersonal and organizational skills
* Global Cultural Awareness
* Ability to work well both independently and in a team environment
* Conducts work in compliance with cGMPs, safety and regulatory requirements
* Seeks and considers feedback
* Ability to prioritize work and multitask.
* Experience in working with strategic initiatives

ADDITIONAL INFORMATION

* Limited travel expected. Travel to Global and Local sites may be required.

This job posting excludes CO applicants.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
 
 
 
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