Posted to MedZilla on 10/21/2018


Takeda Pharmaceuticals

US-MA, Program Manager, Internal Audit R0004677-MZ


 
 

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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 Program Manager, Internal Audit in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Program Manager internal Audit working on the R&D Quality team, you will be empowered to drive continuous improvement and a typical day will include:

OBJECTIVES:

  • Under the guidance of the Associate Director, R&D Internal Audit & Computer Systems Quality, support the internal audit program preparation and execution of global internal audits in R&D. This role partners with the functional groups in R&D and R&D Quality.
  • Provides regulatory and technical expertise to manage the internal audit program and any related continuous improvement opportunities.
  • Work with inspection readiness team members from the functional groups in R&D and R&D Quality to prepare for and support of regulatory inspections

ACCOUNTABILITIES:

  • Supports processes to prepare for and manage internal audits, identifies and engages key Subject Matter Experts from R&D and R&D Quality to participate in audit preparation and management activities.
  • Plans and manages the logistics for the internal audits across multiple sites
  • Evaluates all proposed audit observations and responses to observations and ensures that all CAPAs are appropriate and tracked for timely closure
  • Works closely with the functional areas in R&D and key stakeholders in R&D Quality to prepare comprehensive risk evaluations for development and management of the internal audit schedule.
  • Proactively communicates with stakeholders throughout the internal audit process
  • Provides oversight for the completion of CAPAs from the internal audits, drives the on-time completion of CAPA commitments and maintains metrics on the status of CAPAs.
  • Support regulatory authority inspections as an active participant in the staging room and pre-inspection preparation activities

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

  • Bachelor s Degree in Chemistry, Biology, Engineering or related field. Advanced degree preferred.
  • Minimum 5 years of Quality/Compliance experience.
  • In-depth understanding of global regulations governing the US and international pharmaceutical industries. Ability to translate and articulate appropriate strategies and activities to ensure compliance to all regulations relative to quality management systems.
  • Experience working within complex organizations, working closely with senior staff and executives level colleagues.
  • Experience in identifying and implementing organization-wide compliance initiatives.
  • Ability to influence and work effectively with various business partnerships, regions and cultures.
  • Strong interpersonal skills particularly motivational, negotiation, listening, judgment, and conflict management skills, demonstrated by ability to lead teams in a complex, matrixed and global environment.
  • Excellent organization, verbal and written communication skills to explain project goals and inspire support.
  • Ability to work well with cross-functional teams to accomplish objectives. Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.
  • Demonstrated analytical capabilities with the ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with regulatory compliance.
  • Demonstrated ability to anticipate potential problems and risks related to quality system expectations and regulatory compliance, formulate action plans, and implement solutions

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • 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

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.


Please visit our website at takedajobs.com

 
 


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