Posted to MedZilla on 9/23/2017


Takeda Pharmaceuticals

US-IL, Associate Director Quality Compliance 1702170-MZ


 
 

Takeda is a global, innovation-driven pharmaceutical leader with 30,000 professionals working together across more than 70 countries. We have an unwavering dedication to put patients first for more than 230 years while we live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

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 an Associate Director of Quality Compliance in our Deerfield, IL office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director of Quality Compliance working on the Compliance team, you will be empowered to listen to the patients and ensure the integrity of Takeda s products and mission to put patients first. A typical day will include:

POSITION OBJECTIVES:
  • Engaging cross-functional, cross-company and cross-partner matrixed response teams to respond to high risk, high impact issues.
  • The Associate Director of Quality Compliance will be responsible for creating a clear and unifying vision for the quality compliance area to assure product and process compliance.
  • Strategic design and leadership of the quality compliance function for Takeda Pharmaceutical USA, through implementation of necessary compliance strategies, quality plans and the development and oversight of compliance site programs are also a core responsibility of this role.
  • These programs include site quality council, regulatory support and inspection functions, site metrics and corrective action oversight, product quality communications and the management of customer complaints to mitigate risk and avoid risk of harm to patients, negative regulatory exposure and/or adverse impact to the business.
  • The AD of Quality Control will also establish and implement effective Complaint Investigation programs, addressing risk identification, elevation and monitoring to assure that critical issues are quickly surfaced, understood and resolved. As required, works with other Takeda manufacturing facilities and/or outside vendors, including packagers, manufacturers and suppliers as part of complaint resolution.
  • Lead Regulatory notification and recall programs for Takeda Pharmaceutical USA, including actual event communication and follow up, and recall readiness exercises to manage risk in our dynamic and complex environment of new products and therapies, global supply chains and business partners.
POSITION ACCOUNTABILITIES:
  • Independently and directly represent Takeda Pharmaceuticals, USA Quality to make decisions on complaint program design with business/marketing partners, affiliates, Global Pharmacovigilance and Global Medical Affairs resulting from each business change, including acquisitions, product launches, new business partners and new customer bases to ensure continued compliance and clear business process.
  • Ensure alignment of PV and product complaint management systems through effective process and technology design and management, and effective collaboration with internal and external partners.
  • Establish strategic requirements for enhancement of IT systems/technology platforms for complaint information management and data analysis to enable timely risk identification and to assure regulatory compliance.
  • Lead multidisciplinary, cross-functional and cross-business teams to create strategies for risk assessment and mitigation. Oversee execution of plans and resolution.
  • Manage internal site management notification programs to ensure consistent and accurate messaging. Evaluates and provides improvements to other communications and communication tools to appropriately provide compliance information to other parts of Takeda USA and global partners
  • Manage staff, vendors and business partner relationships for assure compliance with cGMPs, Takeda Quality System expectations and contractual obligations.
  • Represent Takeda Pharmaceuticals USA (TPUSA) Quality during FDA or other regulatory inspections of TPUSA, Takeda (Pharmacovigilance audits) or third party vendors associated with product complaints, the FDA Drug Quality Reporting System, Field Alerts or recalls.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:


  • Minimum 12 years experience in pharmaceutical QA/QC or equivalent
  • Bachelors degree in life sciences, i.e., biology, chemistry, etc.
  • 6 years leadership/people management experience
  • Expertise in cGMPs and other pertinent regulations
  • Project management expertise desired


LICENSES/CERTIFICATIONS:

  • ASQ or other quality or regulatory certification programs preferred.

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings, suppliers, vendors or manufacturing sites, including overnight trips. Some international travel may be required.
  • Requires approximately 10% travel.

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.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.
*LI-DB1-USA


Schedule
Full-time


Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.