Manager, Compliance and Quality Systems

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Job Title: Manager, Compliance and Quality Systems (US Region)

Reports to: Quality Compliance & Systems Lead

Location: Lexington, MA (Hybrid)

About the role:

• Focus on Compliance, and the Quality Systems requirements specific to the Operating Unit/Region

• You will establish Quality Compliance governance, and processes and improve overall operating unit capability.

• This includes oversight and sustainability of the Global Quality Management System and adherence to supplemental local regulatory requirements within the Operating Unit.

• You will support the implementation and execution of strategic electronic systems.

How you will contribute:

• Quality Management System (QMS) - feedback/ implementation and gap assessment of Standards / Procedures ensuring seamless integration of Quality Systems.

• Evaluation of Metrics and Performance Reporting as part of Quality Management Reviews / Councils – Organize and analyze Key Performance Indicator (KPI) data and identify trends to offer solutions.

• Inspection Readiness / Internal Audits and Inspections – Provide support to inspections/audits by means of being SME for the responsibilities and being lead or the co-lead backroom team.

• Documentation and Training –Develop training material for local procedures relevant to the processes assigned to manage. Accountable for the effectiveness of local training programs.

• Change Control Processes and Excursion Management – Local Business Process Owner / Trackwise Subject Matter Expert (SME). Investigate system failures and ensures successful resolution. Conduct training. Apply systems knowledge to offer practical solutions to minimize compliance risk.

• Annual Product Quality Review – Accountable for the coordination and timely delivery of Quality Records data to support APQRs reports. Support OESSM US APQR coordinators in the preparation of reports.

• Technical/Functional (Line) Expertise: Knowledge, and experience of Bio-Pharmaceutical Research, Development, and Manufacturing. Understanding of relevant regulations (FDA, EMA, SFDA) promoting partnerships across the network. Understanding of global and local Quality and Regulatory concepts and requirements (e.g. ICH, EUGMP, Annex 1, Compendia)Understanding of relevant technologies and digital solutions is a must (Trackwise, Documentation/Training platforms (e.g. VEEVA)), Understanding of Local Operating Companies (LOC's).

• Leadership: Effective at directing change and driving change by influence. Ability to operate cross-functionally. Act locally, engaging to support global activities, Enterprise thinking, finding creative ways to serve patients build reputation and trust. Elevating capabilities for now and the future.

• Decision-making and Autonomy: Make Quality Risk-Based decisions. Support Op. Unit/Regional Quality governance (Quality Councils / Management reviews). Responsible for active and timely Incident notifications and associated escalation activities.

• Interaction: Key interactions with Manufacturing and Quality regional and operating unit leaders/teams. Key interactions with CMO's, CPO's, and CTL's. Key interactions with Health Authorities. Support BOH inspection responses and timely completion of related commitments and CAPA.

• Innovation: An awareness of industry, scientific, and regional trends, and an understanding of market conditions. Understand, and use Takeda digitalization systems / electronic solutions.

• Complexity: You will report locally to the Op. Unit, but engages regionally and globally to lead progress and sustainable performance of the One QMS (for both global and local products).

What you bring to Takeda:

Essential Skills:

• Bachelor's Degree

• 7+ years of QA/QC experience in the pharmaceutical industry

• Experience in cGMPs, ICH, and other important regulations

• Digital and analytical skills in Quality Systems and support applications (Trackwise, Documentation and Training platforms (e.g. VEEVA), and MS Office)

• Fluent in written and spoken English

• Travel between Lexington and Cambridge, MA sites

Competency Skills:

• Communication: Communicate ideas, and data both verbally and in writing

• Analytical Skills: Thoughtfully analyze data to make important decisions regarding potential risks associated with product quality or regulatory violations.

• Teamwork: Establish professional relationships with internal and external peers and higher-level management

• Shows Initiative and Proactiveness: Anticipate problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.

• Regulatory Understanding: Broad knowledge of domestic and general knowledge of international regulations associated with manufacturing and packaging

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 a company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

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.

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 to inspire and empowers 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.

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#LI-Hybrid

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EEO Statement

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.