Posted to MedZilla HealthCare on 10/18/2018


Takeda Pharmaceuticals

US-MA, Associate Director, Internal Audit & Computer Systems Quality R0004438-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 an Associate Director, Internal Audit & Computer Systems Quality in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Internal Audit & Computer Systems Quality working on the R&D Quality team, you will be empowered to drive activities to ensure an effective and robust internal audit program in R&D, and a typical day will include:

Objectives:

  • Under the guidance of the Head of R&D Quality Compliance, lead 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.
  • Drive development and implementation of global approach to R&D QA in validation of R&D computerized systems
  • Provides regulatory and technical expertise to manage the internal audit, computer system validation programs and any related continuous improvement opportunities.
  • Manage global effort of establishing and maintaining appropriate R&D QA oversight of internal and external providers of IT related services

Accountabilities:

  • Develops processes to prepare for and manage internal audits, and provides leadership with the internal audit activities.
  • Identifies and engages key Subject Matter Experts from R&D and R&D Quality to participate in audit preparation and management activities.
  • Evaluates all proposed audit observation responses and ensures that all CAPAs are met on time via tracking and timely closure
  • Works closely with the functional areas in R&D and key stakeholders in R&D Quality to prepare to risk evaluation when determining the internal audit schedule.
  • Drives activities for the internal audit execution, including ensuring the selection of appropriately trained auditors, timely conduct and clear and concise documentation of audit findings, and clear and proactive communication with stakeholders throughout the internal audit process.
  • Provides the oversight for the completion of CAPAs from the internal audits, and drives the on-time completion of CAPA commitments.
  • Provides regular reports to R&D Quality leadership on the status of the internal audit program and CAPA commitments.
  • Serves as a strategic thought partner to the Head of R&D Quality Compliance with regard to complex problems and the future strategies of internal audit management in R&D.
  • Provides strategic direction to global functions (in R&D) with respect to regulatory compliance for computerized systems utilized in their respective areas.
  • Create and execute annual audit plan for computerized systems in R&D
  • Manage the global Quality professionals responsible for the internal audit and computer system validation programs.
  • Ensure alignment with the Global Quality Auditing function for internal audit program, computer system validation auditing (internal & external).

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :

  • Bachelor s Degree in Chemistry, Biology, Engineering or related field. Masters preferred.
  • Minimum 8 years of Quality/QC/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
  • Must have an advanced knowledge and understanding of the drug development process, scientific methods and thought processes, specifically the manufacturing process, to ensure regulatory compliance information is up-to-date.

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.

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