This position has responsibility for Quality Assurance, and support of Quality Control, for external Oncology and Small Molecule manufacturing (contract manufacturing organizations, or CMO) and external testing (contract test labs, or CTL), inclusive of API, DP, packaging and labeling activities, located within the US/North American region.
The role holder will support the strategy and plans for the ESQL Quality organization to meet the Quality and OpU vision and objectives , assist in establishing priorities and building a regional patient-centered best in class organization, execute on Quality Improvement projects.
Accountable for the product quality performance at designated 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. Â
Supports and champions implementation of compliance strategies, quality plans and Commercial Quality Assurance programs for the management of Takeda outsourced material procurement, product manufacturing/packaging operations to assure the quality and compliance of Takeda and partner products.
Represent Takeda to make decisions on acceptability of quality programs and ongoing activities at the CMO.
Establish quality and compliance expectations for CMOs and CTLs; performing strategic systems reviews and coordinate 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
Works with ESQL team to support and/or lead audits of CMOs or CTLs, including development or 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 regulatory commitments, assessment and evaluation of risks, appropriate disposition of product, and correction or improvement of operations to minimize future risks.
Maintains awareness of relevant legislation and regulatory guidelines and assures that QA supplier management programs, systems and controls are reviewed and updated as needed to assure compliance. As necessary, confirms requirements and regulations of other Takeda markets in support ofÂ 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 labelingÂ operations.
Assist with regulatory inspections of Oncology, Small Molecule External Supply, other Takeda facilities or third party suppliers associated with the commercial product supply chain.Â 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(Breadth and depth of knowledge, application and complexity of technical knowledge)
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.Â Â
Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)
Ability to make risk based Â 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 organizational 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 organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving)
DOA limits to be defined in line with new TMAP
Responsible for Quality Councils information and resulting management actions
Responsible for supporting Market Action decisions impacting on market productsSupports area budget targets.
Interaction(The span and nature of one's engagement with others when performing one's job, internal and external relationships)
Interacts with stakeholders, regulators, industry peers and othe Takeda quality units.
Innovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
Experience, background, and skills in supportingÂ the development and implementation of an External Network Quality Strategy to deliver against the Quality Roadmap
An awareness Â of industry, scientific and regulatory trends, understands market conditions.
Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
Accountable for Quality performance at CMOs supporting a portfolio of Takeda products.
CMOs supporting X-% of global sales
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education / experience
Bachelor's Degree in Pharmacy, Chemistry, Biology or related discipline and Â miniumum of 8 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 â ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
Analytical Skills â ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
Teamwork â ability to establish professional relationships and rapport with internal and external peers and higher-level management
Proactiveness â ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
Regulatory Understanding â broadÂ based knowledge of domestic and general knowledge of international regulations associated with manufacturing and packaging
Fluent in written and spoken English
Core Competencies / Skills
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
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
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Internal Number: R0029357
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.