This position has responsibility for Quality Assurance Operations and support of Quality Control, for the Oncology, Small Molecule and Biologic external manufacturing at contract manufacturing organizations (CMO) and external testing (contract test labs, or CTL), inclusive of Drug Product (DP), packaging and labeling activities, located within the US/North American region.
The role holder will establish the strategy and plans for the ESQL Quality organization to meet the Quality and OpU vision and objectives , establish priorities, build a regional patient-centered best in class organization, develop diverse talent and elevate organizational performance, execute on Quality Improvement projects and where appropriate, manage the finances of the team.
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. Ensure an environment of continuous improvement.
Accountable for robust supplier quality management practices to support the outsourced manufacturing and testing model in the respective Â regions. Influence supplier Quality practices to ensure product quality performance.
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.
Define and champion 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.
Independently and directly 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 cGMPâs and Takeda Quality System expectations.
As necessary, works with specific Takeda LOCs to assure compliance with country-specific requirements/regulations for the represented markets
Develop and maintain a broad network of relationships within Takedaâs global environment. Represents Takeda and senior management at corporate and regional meetings and, asÂ necessary, with Regulatory Agencies, industry groups and business partners.
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 leadership and oversight in the assessment of critical 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 provides interpretation of regulations, 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 sites.
Assist with FDA or other HA regulatory inspections of Â the Oncology, Small Molecule and Biologic External Supply OpU, 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
Knowledge and understanding of relevant pharmaceutical, device and food regulations in relevant markets.
Broad knowledge and experience of Pharmaceutical and Bio-Pharmaceutical Manufacturing (in particular small molecules and Oncology products)
Knowledge and demonstration of LEAN and Continuous Improvement tools.
Knowledge of Takeda strategy and business performance and using that information to anticipate long range planning for productsÂ
Ability to make difficult, 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 build a customer & patient-centered best in class organization, develop diverse talent and 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
DOA limits to be defined in line with new TMAP
Responsible for Quality Councils information and resulting management actions
Responsible for communicating and taking Market Action decisions impacting on market products
Budget accountability for the Regional Quality OncESSM ESQL lane
Interacts with stakeholders, regulators, industry peers and othe Takeda quality units.
Unique contribution of thought, experience, background, and skills in supportingÂ the development and implementation of an External Network Quality Strategy to deliver against the Quality Roadmap
A firm grasp of industry, scientific and regulatory trends, understands market conditions, and develops strategies to evolve Takedaâs regulatory profile to become the model for the industry.
Accountable for Quality performance at strategic CMOâs supporting Takedaâs core business, and managing high complexity supply chains.
Significant patient and business impact.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education / experience
Bachelors/Masters 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.
10+ years of increasing management responsibility combined with strong technical operations background.
At least 8 years of people management experience desired.
Broad understanding of global Health Authorities requirements in the GMP and GDP regulated area; detailed knowledge of US and EU GMP, ICH, and other relevant 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.
Leadership â ability to effectively lead and motivate a team of direct reports,provide a unifying vision, build on strengths, and address areas for improvement.
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 international regulations associated with manufacturing and packaging
Fluent in written and spoken English
Excellent intercultural communication, negotiation, and practical problem solving skills.
Cross functional and matrix management. Preferred experience in large, multi-national, matrixed organisations.
Core Competencies / Skills
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
Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
Creating the environment that inspires and enables people
Focuing on the few priorities and provide superior results
Elevating capabilities for now and the future
Internal Number: R0029221
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.