External Supply Quality Lead (ESQL), Small Molecule
Singen (Hohentwiel), Germany, Zurich, Switzerland
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External Supply Quality Lead (ESQL), Small MoleculeApply Now
This position has responsibility for Quality Assurance, and support of Quality Control, for external Oncology and Small Molecule manufacturing and analytical testing (Contract Manufacturing Organisations and Contract Test Laboratories), located within the European region, inclusive of Drug Product, packaging, and labelling activities.
The role holder will establish the strategy and plans for the External Supply Quality Sterile & Speciality Products organisation to meet the Quality and Operations Unit 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.
- Accountable for the product quality performance at designated Contract Manufacturing Organisations (CMOs), to ensure compliance and quality risks are identified, communicated and mitigated, and are an integral part of business decisions consistent with cGMP and Takeda Global Quality Standards.
- Accountable for supplier quality management practices to support the outsourced manufacturing and testing model in the region.
- Responsible for product quality performance through product and supplier Quality Risk Management, deviation/investigation review, change management, PQR evaluation, supplier auditing, Key performance Indicators (KPI), and other Quality processes and tools as required.
- 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.
- Supports and champions implementation of compliance strategies, quality plans and Commercial Quality Assurance programmes 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 represents Takeda to make decisions on acceptability of quality programmes and ongoing activities at the CMO.
- Establishes quality and compliance expectations for CMOs and Contract Test Laboratories (CTLs); performing strategic systems reviews and coordinating 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 Local Operating Companies (LOCs) to assure compliance with country-specific requirements/regulations for the packaging of product for represented markets
- Develops and maintains 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, determines their acceptability and agrees corrective action plans.
- Provides leadership and oversight in the assessment of 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 minimise future risks.
- Maintains awareness of relevant legislation and regulatory guidelines and assures that QA supplier management programmes, 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, packaging and labelling operations.
- Assists with 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.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Knowledge and understanding of relevant pharmaceutical, device and food regulations in relevant markets.
- Knowledge and experience of Pharmaceutical and Bio-Pharmaceutical Manufacturing.
- Knowledge of LEAN and Continuous Improvement tools.
- Knowledge of Takeda strategy and business performance.
- Ability to make difficult, risk based 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 build and develop diverse talent and elevate organisational performance, by partnering with stakeholders.
- Ability to operate within and across multiple regions, and cross functionally, works with GMS, Procurement, ESOLs, Product Managers / Product Quality Leaders, Manufacturing Sciences.
- Manages 1 to 5 direct reports.
Decision-making and Autonomy
- Responsible for Quality Councils information and resulting management actions.
- Responsible for supporting Market Action decisions impacting on market products Supports area budget targets.
- Key Stakeholders include: Global Quality Leadership Team, Global Manufacturing & Supply, Regulatory Affairs, Supply Chain, Commercial Organisations, R&D teams, Procurement, Internal Manufacturing sites, Manufacturing Sciences, Quality Compliance and Systems.
- 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.
- An awareness of industry, scientific and regulatory trends, understands market conditions.
- Accountable for Quality performance at CMOs supporting a broad portfolio of Takeda products.
- Product portfolio has high importance to patients and business goals.
- Significant CMOs supporting Takeda global sales.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education / experience:
- Bachelor’s Degree in Pharmacy, Chemistry, Biology or related discipline and minimum 10 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
- At least 2-4 years of direct people management experience is desired.
- Expertise in cGMPs, ICH and other pertinent regulations.
- Project Management expertise desired.
- 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 general knowledge of international regulations associated with manufacturing and packaging.
- Fluent in written and spoken English.
Core Competencies / Skills:
- Critical Thinking.
- Current on local and global regulations.
- 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.
- 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 R0011462