6 days old

Associate Director, External Supply Quality

Takeda Manufacturing U.S.A., Inc
Lexington, MA 02421
  • Job Code
    R0037168

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Job Description

OBJECTIVES/PURPOSE

This position has Quality Assurance responsibility for commercial APIs globally. The leader in this role will have Quality oversight of strategic API suppliers for Takeda. This individual will review significant deviations, change controls, and validations for Takeda APIs, as well as manage/attend periodic business reviews with the CMOs. This individual will also manage disposition and Quality metrics for APIs and CMO performance.

The role holder will establish the strategy and plans for the ESQL Quality organization to meet the Quality and OpU vision and objectives , establish priorities, build a regional patient-centered best in class organization, develop diverse talent and elevate organizational performance, execute on Quality Improvement projects and where appropriate, manage the finances of the team. API manufacturing and Quality System knowledge is required for this role.

ACCOUNTABILITIES

  • Accountable for the product quality performance at designated CMOs, to ensure compliance and quality risks are identified, communicated and mitigated, and are an integral part of busi- ness decisions consistent with cGMP and Takeda Global Quality Standards.
  • Responsible for product quality performance through product and supplier Quality Risk Management, deviation/investigation review, change management, APQR evaluation, supplier auditing, Key performance Indicators (KPI) and other Quality processes and tools as required. Maintain product and process. Ensure an environment of continuous improvement.
  • Accountable for robust supplier quality management practices to support the outsourced manufacturing and testing model in the respective regions. Influence supplier Quality practices toensure product quality performance.
  • Creates a clear and unifying vision for the ESQL area to assure product and process compliance. Fosters enthusiasm, commitment, and dedication to the unifying vision within the team.
  • Define and champion implementation of compliance strategies, quality plans and Commercial Quality Assurance programs for the management of Takeda outsourced material procurement, product manufacturing/packaging operations to assure the quality and compliance of Takeda and partner products.
  • Independently and directly represent Takeda to make decisions on acceptability of quality programs, and ongoing activities at the CMO.
  • Establish quality and compliance expectations for CMOs and CTLs; performing strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with cGMP's and Takeda Quality System expectations.
  • As necessary works with specific Takeda LOCs to assure compliance with country-specific requirements/regulations for the represented markets
  • Develop and maintain a broad network of relationships within Takeda's global environment. Represents Takeda and senior management at corporate and regional meetings and, as necessary, with Regulatory Agencies, industry groups and business partners.
  • Works with ESQL team to support and/or lead audits of CMOs or CTLs, including development or audit reports and review of the acceptability of CMO/CTL corrective actions.
  • Provide leadership and oversight in the assessment of critical changes or deviations for Takeda products, to assure compliance to regulatory commitments, assessment and evaluation of risks, appropriate disposition of product, and correction or improvement of operations to minimize future risks.
  • Maintains awareness of relevant legislation and regulatory guidelines and provides interpretation of regulations, and assures that QA supplier management programs, systems and controls are reviewed and updated as needed to assure compliance. As necessary, confirms requirements and regulations of other Takeda markets in support of manufacturing, testing and packaging activities.
  • Ensure successful and timely completion of all product submissions, launches and new Takeda initiatives within Takeda, as well as at our contract manufacturing sites.
  • Assist with FDA or other regulatory inspections of Oncology, Small Molecule External Supply, other Takeda facilities or third-party suppliers associated with the commercial product supply chain. May represent Takeda during regulatory inspections, as needed.
  • Identifies key trends and emerging issues at suppliers and implements corrective actions as needed.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Education I experience

Bachelor's Degree in Pharmacy, Chemistry, Biology, or related discipline, and minimum of 12 years of QA/QC experience in the pharmaceutical industry, and/or QA/QC laboratory environment.

10+ years of increasing management responsibility combined with strong technical operations background.

API experience desired.

Broad understanding of global Health Authorities requirements in the GMP and GDP regulated area; detailed knowledge of EU GMP, ICH, and other relevant regulations; and experience of the duties of the EU Qualified Person.

Project Management expertise desired.

Skills required:

  • Communication - ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
  • Analytical Skills - ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
  • Leadership - ability to effectively lead and motivate a team, provide a unifying vision, build on strengths, and address areas for improvement.
  • Teamwork - ability to establish professional relationships and rapport with internal and external peers and higher-level management
  • Proactiveness - ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
  • Regulatory Understanding - broad based knowledge of domestic and international regulations associated with manufacturing and packaging

Fluent in written and spoken English

Excellent intercultural communication, negotiation, and practical problem-solving skills.

Cross functional and matrix management. Preferred experience in large, multi-national, matrixed organizations.

Core Competencies / Skills

Critical Thinking

Current on local and global regulations

Digital and analytical skills

Investigation and problem solving

Strong communication skills engaging stakeholders: site, business, network, company, regulators

Risk identification, evaluation arid management

Continuous improvement

Leadership Behaviors

Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust

Creating the environment that inspires and enables people

Focusing on the few priorities and provide superior results

Elevating capabilities for now and the future

This job posting excludes CO applicants.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-07 Expires: 2021-07-06
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Associate Director, External Supply Quality

Takeda Manufacturing U.S.A., Inc
Lexington, MA 02421

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