Head of Quality Control - Oncology and External Supply Small Molecule, European Region
Singen (Hohentwiel), Germany, Zurich, Switzerland
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Head of Quality Control - Oncology and External Supply Small Molecule, European RegionApply Now
- Responsible for establishing the strategic compliance direction and management of analytical release/stability activities. Activities include but are not limited to data review, tracking and trending, authoring of stability protocols and reports, supporting regulatory submissions, managing contract service providers and coordinating study executions, performing and/or providing audit support.
- The role holder will establish the strategy and plans for the Quality Control team to meet the Quality and Operating Units vision and objectives, establish priorities, build a regional patient-centred best in class organisation, develop diverse talent and elevate organisational performance, execute on Quality Improvement projects and where appropriate, manage the finances of the team.
- Independently and directly represent Takeda to make decisions on acceptability of Third Party Testing Laboratories (CTL) quality programmes, and ongoing activities.
- Support the assessment of methods, specifications, stability protocols, development reports, analytical validations, analytical transfers, statistical packages, expiry extensions, analytical reports and the assessment of critical analytical changes or deviations, as needed to assure compliance to Takeda standards, regulatory requirements and GMPs.
- Responsible to ensure all Takeda annual stability testing requirements are met, and compliance is maintained, while minimising cost impact.
- Responsible for associated Quality Control budget supporting the Oncology & External Supply Small Molecule (OncESSM) Takeda commercial stability programme, providing detailed forecasts and assessments of spend.
- Supports the laboratory investigations and assesses risks for non-conforming product or operations, develops appropriate action plans, including system correction or improvement of operations to minimise future risks for commercial products.
- Subject Matter Expert (SME) in current and emerging regulatory requirements and industry best practices.
- Subject Matter Expert supporting External Supply Quality Lead (ESQL) teams on testing strategies for new or existing products to ensure GMP and Takeda expectations are met. Ensures the establishment of remediation plans if needed to improve analytical testing strategies.
- Participates in the development and implementation of Global Procedures and Standards.
- Leads or supports audits efforts as needed, to support business and compliance objectives.
- Additional duties as assigned, and as needed to support other key areas such as Quality Assurance, Quality Control, Quality Systems and Quality Compliance
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Broad knowledge and understanding of relevant pharmaceutical, device and food legislation in Europe and relevant markets.
- Broad knowledge and experience of Pharmaceutical and Bio-Pharmaceutical Manufacturing (in particular small molecules and Oncology products).
- Knowledge and understanding of global and local Quality and Regulatory concepts and requirements (e.g. ICH, EUGMP, Annex 1, Compendia, etc.).
- Knowledge of LEAN and Continuous Improvement tools.
- Knowledge of Takeda strategy and business performance and using that information to anticipate long range planning for products.
- Ability to make difficult, but robust and rationalised Quality decisions impacting products and services within scope, enabling Takeda to deliver on its commitment to put patients first and build trust with society.
- Ability to elevate organisational performance through mentoring and coaching, and by partnering with stakeholders.
- Ability to build a customer & patient-centred best in class organisation, develop diverse talent and elevate organisational performance, by partnering with stakeholders.
- Ability to operate within and across multiple regions, and cross functionally, works with Global Manufacturing & Supply, Procurement, External Supply Operations Leads, Product Managers / Product Quality Leaders, Manufacturing Sciences.
- Manages up to 5 direct reports.
Decision-making and Autonomy
- Ability to make complex decisions that impact supply from Contract Manufacturers/ Suppliers.
- An active member of OncESSM Quality Europe Team, accountable for Quality Council information.
- Budget accountability for the Regional Quality OncESSM Quality Control lane.
- Establish strong relationships with stakeholders including ESQL, Contract Manufacturing Organisations (CMOs) and Takeda Local Operating Companies. This position interacts with External Supply Quality Lead (ESQL), External Site Leads, Supply Planning, Artwork and other internal stakeholders, as well as Europe based Contract Manufacturers/ Suppliers.
- Interacts with stakeholders, regulators, industry peers and other Takeda quality units.
- Unique contribution of thought, experience, background, and skills in supporting the development and implementation of an External Network Quality Strategy to deliver against the Quality Roadmap.
- Ability to drive organisational change and continuous improvement.
- 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.
- Accountable for analytical activities at strategic CMOs or CTLs for Takeda’s Oncology and Small Molecule commercial products.
- Significant patient and business impact.
- Strong analytical skills to accurately assess impact of proposed changes to existing processes, and to determine if and when quality improvements are needed.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education / 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.
- Preferably 2+ years’ experience in preparing Chemistry, Manufacturing and Control (CMC) documentation related to pharmaceutical analysis.
- At least 6 years of people management experience desired.
- Broad understanding of Global Health Authorities requirements in the GMP and GDP regulated area; detailed knowledge of GMP, ICH, and other relevant regulations.
- Knowledgeable in the application of compendia requirements and procedures to testing of pharmaceutical products.
- Fluent in English language oral/written communication skills.
- Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
- Analytical Skills – ability to thoughtfully analyse 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 of direct reports, 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.
- Familiarity with SAP, GMP Enterprise Systems, MS Word and MS Excel.
- Excellent intercultural communication, negotiation, and practical problem solving skills.
- Cross functional management. Preferred experience in large, multi-national, matrixed organisations.
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 and management.
- Continuous improvement.
- 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.
Job ID R0011464