Takeda Pharmaceutical

Quality Assurance Manager

Posted Dec 17, 2019
Project ID: SHPGJP00004724
Location
Exton , PA
Duration
6 months (Jan 1, 2020 - Jun 30, 2020)
Hours/week
40 hrs/week
Payrate range
Unknown
6 mo assignment.
True title is QA Disposition Manager

OBJECTIVES/PURPOSE (3-4 bullets)
 This position has responsibility for performing Batch Disposition activities for Global API and US
Drug Product, Finished Goods in accordance with their Registered Approvals or Marketing
Authorizations, their Manufacturing Authorizations, Takeda Global Quality Standards and
Procedures, and the princilples and guidelines of current Good Manufacturing Practices.
SCOPE
Financial: Est. annual revenue range of accountability*: Oku Yen
Est. annual budget of responsibility: Oku Yen
Leadership/People: No. of direct reports: 0 No. of indirect reports 0
Geographic Scope: Global API CMO’s, CTL’s and associated LOCs/ customers
*if applicable
ACCOUNTABILITIES (Describe the primary duties and responsibilities of the job. Include only the
essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).
 Assists with the prioritisation and coordination of batch release activities, to prevent supply
disruption.
 Review of batch record information from Contract Manufacturers/ Suppliers, and compilation of
batch documentation for review according to Takeda requirements and SAP inspection plans.
 Transfer needed information from Contract Manufacturers/ Suppliers batch documentation into
Takeda systems e.g. LabLIMS and SAP/BPR
 Prepare and review batch documentation for release, including upload of batch certificates to the
repository.
 Archive batch documentation according to Takeda and customer requirements.
 Perform Technical Release of products in SAP/BPR based on release certificates from Contract
Manufacturers/ Suppliers
 Support other fnctions as needed with e.g. PQR preparation, deviations, change controls, and
CAPA.
 Maintence of product lists and Quality relevant SAP master data.
 Provides other support/input as needed to ensure the effective oversight of Contract
Manufacturers/Suppliers and compliance of OncESSM procedure/processes with Takeda
requirements, and GMP.

Page 2 of 3 Job Description/ Role Profile

DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of
technical knowledge)
 Knowledge and understanding of relevant pharmaceutical regulations in US, Japan, Europe
and relevant markets.
 Knowledge and experience of Bio-Pharmaceutical Manufacturing (in particular small molecules
and Oncology products)
 Knowledge of LEAN and Continuous Improvement tools.
Leadership (Vision, strategy and business alignment, people management, communication, influencing others,
managing change)
 Ability to make risk based Quality decisions impacting products and services within scope of
oversight, and prioritise accordingly.
 Ability to elevate organizational performance by partner with stakeholders.
 Ability to operate within and across multiple regions, and cross functionally.
Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in
decision-making, complexity of decisions, impact of decisions, problem-soliving)
 Responsible for day to day dispositon decision with CMO/CTL.
 Responsible for escalating any issues identified during review of manufacturing/analytical
information provided from CMO/CTLs.
Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external
relationships)
 Key Stakeholders include: OncESSM ESQL, GMS,Regulatory Affairs, Supply Chain,
Commerical organizaitons, R&D teams, Procurement, Internal Manufacturing sites,
Manufacturing Sciences, Quality Systems and Compliance.
 Interacts with stakeholders, regulators, industry peers and othe Takeda quality units.
Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
 A firm grasp of industry, scientific and regulatory trends, understands market conditions, and
develops strategies to evolve Takeda’s regulatory profile to become the model for the industry.
 Demonstrates an understanding of priorities, objectives, and project timelines.
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural
considerations)
 Accountable for supporting disposition activities at CMOs or CTLs for Takeda’s Oncology and
Small Molecule commercial products.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and
desirable education and competency requirements to perform the primary responsibilities of the job.
Any minimum requirements should be noted.)
 Bachelor's Degree in Pharmacy, Chemistry, Biology, or related discipline
 Minimum 6 years of QA/QC experience in the pharmaceutical industry
 Demonstrated teamwork, initiative, and problem-solving skills
 Fluent in English language oral/written communication skills
 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

Page 3 of 3 Job Description/ Role Profile
and data to make key decisions regarding potential risks associated with
product quality or regulatory violations.
 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
general knowledge of international regulations associated with manufacturing
and packaging
Core Competencies / Skills
 Critical Thinking
 Digital and analytical skills
 Investigation and problem solving
 Good communication skills engaging stakeholders: site, business, network, company,
regulators
 Risk identification, evaluation and management
 Continuous improvement
Leadership Behaviors
 Enterprise thinking, finding innovative ways to improve compliance and process
 Elevates capabilities of the organization
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