External Supply Quality Manager, Oncology Products, European Region応募 後で応募 求人ID R0011689 掲載日 08/29/2019 Location:Wicklow, Ireland
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 External Supply Quality Manager is responsible for the Quality oversight of a portfolio of Contract Manufactures and associated products. The position requires interaction with numerous functions within the Oncology & External Supply Small Molecule (OncESSM) Operating Unit, and other External Supply regions, with Takeda manufacturing sites, Takeda Local Operating Companies (LOCs), and external partners.
- Responsible 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.
- 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. Supports an environment of continuous improvement.
- 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.
- Represents Takeda to make decisions on acceptability of quality programmes and ongoing activities at CMOs.
- 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 LOCs to assure compliance with country-specific requirements/regulations for the packaging of product for represented markets
- Supports and/or leads audits of CMOs or CTLs.
- Provides 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 audits and inspections of Oncology & External Supply Small Molecule, other Takeda facilities, and 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 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 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 Operatiosn Leads, Product Managers / Product Quality Leaders, Manufacturing Sciences.
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: GMS, Regulatory Affairs, Supply Chain, Commercial organisations, R&D teams, Procurement, Internal Manufacturing sites, Manufacturing Sciences, Quality Compliance & Systems.
- Interacts with stakeholders, regulators, industry peers and other Takeda quality units.
- 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.
- Responsible for Quality performance at CMOs supporting a portfolio of Takeda products.
- Product portfolio has high importance to patients and business goals.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education / Experience:
- Bachelor’s Degree in Pharmacy, Chemistry, Biology or related discipline and minimum of 5 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
- Experience of 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.
- 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.
- Focusing on the few priorities and provide superior results.
- Elevating capabilities for now and the future.