Manager Quality Control

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

Here, you will be a vital contributor to our inspiring, bold mission.

“At our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disAbility. Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?”

In this role, you will contribute to Takeda’s mission by having the ability to lead effectively and work concurrently across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy. A typical day will include:

OBJECTIVES/PURPOSE

• This position has responsibility for operational, technical and compliance oversight for Global Oncology External Supply Small Molecule (OncESSM) Quality Operating Unit (OpU) Quality Control (QC) release and stability testing performed at external service provider (contract test labs and manufacturing organizations; CTLs and CMOs) for small molecule, recombinant biologics and cell therapy products as part of the global QC function
• Create, maintain analytical documentations, e.g. protocols, reports, specifications, methods, etc.
• Directly liases with, and manages, relationships with external testing partners to ensure continuity of testing, investigation and resolution of unexpected results and represents Takeda in interactions with providers
• Develops, compiles and monitors performance metrics and drives continuous improvement of activities within QC organization
• Lead or support analytical and manufacturing investigations of unexpected results to identify root cause and defines and implements corrective or preventive actions
• Works closely with OncESSM Quality OpU leadership to support the forecast of future spend, monitoring variances, and drive improvements with financial benefit.
• Provides support to data analysis, data entry, purchase order creation/reconciliation and financial oversight of third party labs in Europe and other regions as required by the third party lab locations.
• Supports compliance of testing network through participation in external provider audits, data review and data integrity verification, development of quality agreements and assures execution to requirements.
• Support regulatory filing and product APQR.

ACCOUNTABILITIES

Primary duties of the position are focused around non-laboratory support of the QC functions. Primary activities would generally include but not limited to data analysis, data trending, project and testing coordination, product and material specification management, inspection support, investigation leads, operational excellence leads, document revisions, initiating/completing quality systems, method/equipment validation and method projects activities.

• Act as deviation/Lab investigation owners, support Out Of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and help drive to closure in timely manner.
• Collates and reports out third party lab performance metrics
• Provides financial oversight of third party labs to assure budget requirements are met and is accountable for the CTL financial processes execution (ie. PO generation, invoice processing, etc.) of the Global OncESSM Quality Control unit.
• Work with the head of OncESSM QC, QC Business Operations Lead and QC Strategy and Business Operations to provide input on financial estimates and assumptions.
• Develops testing plans and support method transfers as needed
• Manage stability study protocol development, execution, data analysis and reporting for OpU products as designated
• Develop explanations for financial variances that occur on a monthly basis and make recommendations.
• Develop data summary and communication tools such as dashboards, reports and product quality review.
• Evaluate business processes and propose and carry through continued improvement opportunities.
• Cultivate and maintain relationships with key internal and external customers.
• Initiate Change Controls to support change of vendor/TPIC specification documents, vendor test methods, stability protocols, and relevant site batch records.
• Be a valued partner by providing actionable decision support (e.g. what-if scenarios for decision making).
• Provide technical support to other QC activities as business needs arises.
• Maintain training records current and GMP compliance when conducting Takeda business.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Expertise in analytical chemistry and techniques.
• In depth knowledge and understanding of relevant pharmaceutical and device regulations in global markets.
• General knowledge and experience of Pharmaceutical and Bio-Pharmaceutical Manufacturing (in particular small molecules and Oncology products)
• General knowledge of Takeda strategy and business performance, and using that information to anticipate long range planning for products

Leadership

• Demonstrate technical leadership with minimum supervision. Able to provide technical guidance to team members. Able to independently find solutions to technical and quality issues.

• Ability to make quality risk based recommendations impacting CTL services, enabling Takeda to deliver on its commitment to put patients first and build trust with society.
• Ability to operate within and across multiple regions, and cross functionally.
• Ability to collaborate effectively with various cross-functional groups within the company as well as with external vendors. Experience with companies outside Europe

Decision-making and Autonomy

• Able to make technical and quality decisions with minimum supervision and guidance. Able to lead complex investigations and provide technical guidance to CMO and CTL.
• Responsible for fulfilling requests for analytical information to support Quality Councils.
• Responsible for escalating any analytical issues identified during review of analytical information provided from CTLs or during data trending
• Financial process accountability for the CTL finances of the Global OncESSM Quality OpU.
• Responsible for working independently or with management and other Takeda entities for issue identification and resolution at the CTL based on risk.

Interaction

• Key Stakeholders include: OncESSM ESQL, GMS, Regulatory Affairs, Supply Chain, Commercial organization, R&D teams, Procurement, Internal Manufacturing sites, Manufacturing Sciences, Quality Systems and Compliance
• Interacts with stakeholders, regulators, industry peers and other Takeda quality units.

Innovation

• A firm grasp of industry, scientific and regulatory trends.
• Demonstrates an understanding of priorities, objectives, and project timelines. This includes understanding how QC activities affect the business.
• Able to propose improvement ideas for continuous improvement of business processes and quality. Leads improvement projects.
• Demonstrates good understanding of analytical methodology.
• Can work through critical conversations with the CTL with regards to financial process execution.

Complexity

• Accountable for financial process execution supporting the Global OncESSM Quality OpU products.
• Accountable for supporting analytical activities at CMOs or CTLs for Takeda’s Oncology and Small Molecule commercial products

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• MS or PhD in Chemistry, Biology, or related scientific discipline.
• 10+ years experience in in the pharmaceutical industry R&D and/or QC laboratory environment.
• Must have in-depth understanding of a variety of analytical techniques such as Mass Spectrometry, NMR, HPLC, dissolution, GC, FTIR, wet chemistry and other analytical techniques. Must have broad experience in analytical investigations, handling of OOS, OOT investigations.
• Experience in small molecule API and oral solid dosage is a must.
• Experience in analytical laboratory, method execution, qualification and/or validation of small molecule or biologics assays.
• Experience in managing stability programs.
• Experience in regulatory support, authoring dossier sections, respond to regulatory inquires.
• Strong communication and technical writing skills.
• Cross functional and matrix management experience.
• Awareness of financial processes.
• Project management experience is a plus.
• In depth understanding of applicable regulations and guidances.
• Strong proficiency in Microsoft tools, especially Excel.
• Knowledge of Laboratory Information Systems (LIMs).

Skills required:

• Communication – strong verbal and written communication skills with the ability to communicate ideas and data in a persuasive, organized, and appropriate manner.
• Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions.
• Teamwork – ability to establish professional relationships and rapport with internal and external peers and higher-level management.
• Proactiveness – ability to anticipate potential problems and taking the initiative to address these issues.
• Regulatory Understanding – general knowledge of regulations associated with manufacturing and packaging.
• Customer Service Orientation - ability to gain trust of leadership and leverage relationships to provide best possible financial plans.
• Fluent in written and spoken English.

Core Competencies / Skills

• Critical thinking
• Problem solving
• Digital and analytical skills
• Continuous improvement mindset
• Current on local and global regulations
• Business oriented with a good business understanding
• Strong communication skills engaging stakeholders

Leadership Behaviors

• Enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Drive for results, meeting customer expectations and able to influence relevant internal and external stakeholders.
• Proactive and self-motivated, with a hands on attitude and approach.
• Excellent intercultural communication, negotiation, and influencing.
• Open-mindedness towards change, and a desire to learn.
• Focusing on the few priorities and provide superior results.
• Elevating capabilities for now and the future.

WHAT TAKEDA CAN OFFER YOU

• Excellent conditions & benefits including generous holidays
• Genuine career progression and development
• Opportunity to work with a world class leader in the pharmaceutical sector

At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.

Empowering Our People to Shine

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