Cambridge, MA, United States
Senior Manager External Supply Quality
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as at our Cambridge Location.
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.
This position has responsibility for
Quality Assurance, and support of Quality Control (as applicable), 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
Support the establishment of the strategy
Plans for the ESQL Quality organization
Meet the Quality and OpU vision and objectives,
Assist in establishing priorities,
Building a regional patient-centered best in class organization,
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.
Accountable for supplier quality management practices to support the outsourced manufacturing and testing model in the respective regions
Executes 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 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.
Communicate 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 representatives to assure compliance with country-specific requirements/regulations for the packaging of product for represented markets
Support and maintain a broad network of relationships within Takeda’s global environment. Represents Takeda and senior management at corporate and regional meetings, as 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 and 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.
Maintain 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 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 labeling operations.
Assist with FDA or other 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.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
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 analyze 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 – 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
Creating the environment that inspires and enables people
Focusing on the few priorities and provide results
Elevating capabilities for now and the future
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.