Takeda Pharmaceuticals Associate Director- Compliance and Quality Business Systems in Lexington, Massachusetts
About the role:
Ensure compliance to Global Quality Management GxP systems.
An OESSM OpU Qualilty Business subject matter expert (SME) and contact for SAP(ECC and MDG) and intertwining systems.
Lead, Implement and approve change or enhancements for OESSM for such systems. Provide guidance to areas across the OpU.
You will ensure OESSM is supported regarding Main Users and Master Data governance.
You will guide digital innovation.
How you will contribute:
Provide oversight as important IT Quality SME for OESSM.
SAP (ECC and MDG) -key / Superuser and contact for OESSM SAP to Global SAP process.
Manage OESSM specific Users and User Community to gather and evaluate enhancements
Governance of and support of SAP onboarding through management of training and certification of SAP role requests.
OESSM Quality SME to facilitate global business and project teams for IT system implementations.
Provide oversight in the assessment of change or enhancements for IT changes, through the evaluation of risk to ensure compliance to regulatory commitment and Data Integrity within an aligned Quality Management system.
Manage implementation of Global Business and IT strategy for the OpU.
Maintain a harmonized Master Data Governance process.
Use process and product knowledge to manage digital innovations within OESSM QMS systems including SAP, to improve efficiency and digital IT improvement
Participate in and support OncESSM audits/ Regulatory Inspections and ensure its readiness around the process aspect.
Technical/Functional (Line) Expertise
Knowledge of relevant regulations (FDA, EMA,SFDA) ensuring partnerships across the network
Understanding of global and local Quality and Regulatory concepts and requirements (e.g. ICH, EUGMP, associated Annex , Compendia)
Understanding of relevant technologies, LEAN and digital solutions is a must (Track Wise, Qlik/ Power BI, SAP)
Knowledge of Takeda strategy and our performance.
Directing change and driving change by influence
Ability operate within multiple regions engaging with internal, external and global partners
Act globally and engaging to support regional activities
Decision-making and Autonomy
Escalates issues to the line manager
Communicate and resolves conflicts
Work with staff, peers, global teams, and management to achieve our goals.
Understand and use Takeda digitalization systems / electronic solutions
Support an environment of continuous improvement and digital innovations to achieve the Takeda Quality Roadmap
You will report to the OpU, but engages regionally and globally to guide progress and sustainable performance of One QMS and its Business Systems (for both global and local products).
What you bring to Takeda:
Education / Experience
Minimum of Bachelor's Degree in Science/ Engineering/Quality related discipline.
Minimum of 8 years experience in the pharmaceutical industry and QA environment and management in an electronic system.
In-depth knowledge of SAP/ECC, ERP IT system, especially QM module and its related Master data.
Knowledge of cGMPs, ICH and other relevant regulations
Project Management expertise.
Thoughtfully analyze data to make important decisions regarding potential risks associated with product quality or regulatory violations.
Teamwork – internal and external peers and higher-level management.
Proactiveness – foresee any 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.
Required skills / Skills
Current on local and global regulations.
Digital and analytical skills on Quality Systems and support applications
Engage partners site, business, network, company, regulators.
Risk identification, evaluation and management.
Enterprise thinking - finding creative ways to serve patients build reputation and trust.
Focus on the few priorities and provide results.
Improve capabilities for now and the future.
International Travel may be required (< 10%)
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and company match of charitable contributions
Family Planning Support
Professional training opportunities
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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