External Supply Quality Manager応募後で応募 求人ID R0036221 掲載日 06/15/2021 Location:Zurich, Switzerland
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a External Supply Quality Manager at our Zurich office.
Here, you will be a vital contributor to our inspiring, bold mission.
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:
This position has responsibility for Quality Assurance, and support of Quality Control, for external Oncology and Small Molecule Contract Manufacturing Organisations (CMOs), Suppliers, and Contract Testing Laboratories (CTLs) 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 CMOs/ Suppliers, to ensure compliance and quality risks are identified, communicated and mitigated, and are an integral part of business decisions consistent with relevant standards/ cGMP and Takeda Global Quality Standards. Responsible for the preparation, approval and maintenance of Quality Agreements with relevant CMOs/ Suppliers. Responsible for product quality performance through product and supplier Quality Risk Management, deviation/investigation review, change management, APQR evaluation, Key Performance Indicators (KPI) and other Quality processes and tools as required.
- Support and champion the implementation of compliance strategies, quality plans and Quality Assurance programmes for the management of Takeda outsourced product manufacturing/ packaging operations to assure the quality and compliance of Takeda and partner products.
- Represent Takeda to make decisions on acceptability of quality programmes and ongoing activities at the CMO/ Supplier.
- Responsible for complying with the requirements of the Quality Incident Management process for relevant CMO/ Supplier manufactured products. Prepares and issues notifications and prepares for Quality Alignment Meetings in collaboration with the ESQL and/or Site Quality Head, and other stakeholders.
- Establish quality and compliance expectations for CMOs/ Suppliers and support as needed CTLs; performing strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with relevant standards/ cGMP and Takeda Quality System expectations.
- As necessary work with specific Takeda LOCs to assure compliance with country-specific requirements/regulations for the manufacturing/ packaging of product for represented markets.
- Support and/or lead audits of CMOs/ Suppliers and CTLs, including preparation of audit reports and review of the acceptability of CMO/CTL corrective actions.
- Provide oversight in the assessment of changes or deviations for Takeda products, to assure compliance to market/ regulatory commitments, assessment and evaluation of risks, support appropriate disposition of product, and correction or improvement of operations to minimize future risks.
- Maintain awareness of relevant legislation and regulatory guidelines, and assure that QA supplier management programmes, systems and controls, are reviewed and updated as needed to assure compliance. As necessary, confirm 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 contract manufacturing, packaging and labelling operations.
- Assist with audits and inspections of Oncology & External Supply Small Molecule, other Takeda facilities, and third-party suppliers associated with commercial product supply. May represent Takeda during regulatory inspections, as needed
DIMENSIONS AND ASPECTS
- Knowledge and understanding of relevant pharmaceutical/ biopharmaceutical and device regulations in relevant markets.
- Knowledge and experience of pharmaceutical and/or biopharmaceutical manufacturing.
- Knowledge of LEAN and Continuous Improvement tools. Knowledge of Takeda strategy and business performance.
- Product and process knowledge.
- 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, 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 GMS, Procurement, ESOLs, Product Managers / Product Quality Leaders, Manufacturing Sciences.
- Decision-making and Autonomy (The capacity and authority to make organisational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
- DOA limits to be defined in line with new TMAP.
- Responsible for Quality Council information and resulting management actions.
- Responsible for supporting Market Action decisions impacting on market products.
- Supports area budget targets.
- Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
- Key Stakeholders include: GMS, Regulatory Affairs, Supply Chain, Commercial organizations, R&D teams, Procurement, Internal Manufacturing sites, Manufacturing Sciences, Quality Compliance & Systems
- Interacts with stakeholders, regulators, industry peers and the Takeda quality units.
- Support an environment of continuous improvement
- An awareness of industry, scientific and regulatory trends; understanding of market conditions.
- Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
- Responsible for Quality performance at CMOs supporting a portfolio of Takeda products.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education / Experience
- Minimum of 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, etc.
- Risk identification, evaluation and management.
- Continuous improvement.
- Enterprise thinking - finding innovative ways to serve patients build reputation and trust. Focus on the few priorities and provide superior results.
- Elevate capabilities for now and the future.
International travel as needed to support the business
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 Future to people around the world.
Empowering Our People to Shine