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Biologics & Plasma Complaints & Data Analytics Manager

Lexington, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

At Takeda, your data skills will change lives. As the Manager of Data Analytics, you will have the opportunity to improve our plants and functions operations and allow you to work with interesting and demanding data. Choose where you want to work across our Global Manufacturing & Supply Network around the world and enjoy the dynamic spirit of the Takeda Global Manufacturing and Supply Chain team.

Are you eager to be a part of an innovative environment that makes a difference in patients’ lives? Then join our new, dynamic and highly motivated Data Analytics team today - we are looking forward to receiving your application.

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Success

What makes a successful Global Data Scientist? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Team Player
  • Analytical
  • Curious
  • Digital
  • Communicator

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Life at Takeda

  • Christos Michos

    Senior Manager of Data Analytics, Zurich, Switzerland

    Christos Michos
    “Conveying the message of Digital in a succinct, subtle and precise way gives me a deep sense of satisfaction.”
  • Wolfgang Eck

    Senior Director & Plant Manager, Oranienburg, Germany

    Wolfgang Eck
    “We are challenging our people and our processes to an extent we have not done before.”
  • Susan Tillman

    Global Head of Innovation, Zurich, Switzerland

    Susan Tillman
    “Join us on our digital mission: Plants becoming integrated, automated and based on analytics - Supply Chain being transformed and made more efficient by analytics and new technologies.”

Opportunity

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

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Biologics & Plasma Complaints & Data Analytics Manager

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Job ID SR0039325 Date posted 11/06/2019 Location Lexington, Massachusetts

OBJECTIVES/PURPOSE

Responsible for writing and approving product quality complaints and managing the data analytics and trending assocated with the complaint handling program at Takeda per corporate procedure and regulatory standards including goal setting in-line with corporate strategy and priorities and the GQ road map.

The scope of responsibility encompasses timely management of the complaint processes to comply with corporate procedures, EU and FDA regulations, ISO13485 and other regulatory requirements as applicable. Escalate and participate in resolution of potential product deficiencies for all applicable Takeda products originating from a market complaint. Liaise with Internal Stakeholders, Call Centres and service providers to ensure they support Takedas corporate policies and guidance while aligning with all of the necessary regulations and standards. Serve as the Quality liaison between individuals and business units within or outside the organization regarding matters related to product complaint activities, including risk management, regulatory inspections and complaint handling processes for all applicable products. Identify and drive continuous improvement to ensure a lean and compliant process. Generate complaint metric performance data and act with the wider team to take actions to meet required targets. Act as SME for complaint sections of Annual Product Quality Reviews (APQR’s).

ACCOUNTABILITIES

  • Initiating, writing and managing the complaint investigation to completion.
  • Managing the data analytics and trending associated with the complaint handling program.
  • Serve as point of contact for commercial & clinical product complaints and post market product vigilant monitoring processes
  • Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and/or provide oversight for complaint handling process.
  • Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
  • Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
  • Interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc and the regional organisation. Interface with external stakeholders such as  CMO, Call Centers and vendors/contractors on product complaint issues.
  • Assure that all product complaints are investigated to the appropriate level within the required timeline.
  • Critically review and approve complaint investigations and send customer response letter.
  • Represent Takeda as the Subject Matter Expert (SME) for the product complaints process during Internal, External and Regulatory Body Inspections.
  • Drive continuous Improvement to ensure a lean and compliant process

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Minimum of a Bachelor's degree with a minimum of 7 years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing.
  • Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
  • Experience in Data Analytics and Metric Management.
  • Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
  • Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
  • Good understanding of the manufacture of combination products and the linkage to customer complaints.
  • Strong attention to detail, good organizational skills and well-structured.
  • Has a systematic way of working, prioritizing tasks based on risk or criticality - seeking effective solutions within the complexity that surrounds product complaints.
  • Excellent troubleshooting and problem-solving skills.
  • Skill in writing investigation summaries and complaint responses.
  • Independent, organized and able to schedule work without supervision to meet schedule deadlines.
  • Ability to work independently as well be an effective team member and leader.
  • Approachable and possess the ability to forge solid working relationships with colleagues across all functions, its partners and contractors.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0039325

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