Talent.com
Compliance Operations Lead, Associate Director (Hybrid)

Compliance Operations Lead, Associate Director (Hybrid)

Takeda PharmaceuticalsBoston, MA, US
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Job Description

Objectives :

  • Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ
  • Partner with teams across CPMQ to proactively assess the needs for functional processes and system enhancements
  • Lead the development of internal functional processes and training and ensure alignment with global processes and regulatory requirements and expectations.
  • Drive the implementation and change management of processes and systems across CPMQ
  • Create mechanism to monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans
  • Engage with CPMQ teams to foster a culture of learning and continuous improvement
  • Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities.
  • Provide expert advice and support to the CPMQ team on quality compliance activities.
  • Partner with Global Quality, R&D Quality teams and contribute to enterprise-wide solutions.

Accountabilities :

  • Leads and create simplified End to End functional processes and tools to enable execution of CPMQ activities, ensuring alignment with global processes and regulatory requirements.
  • Create and deliver training solutions to support the learning and implementation of functional processes and systems
  • Create and implement change management plans for new and revised CPMQ processes and systems.
  • Manage the CPMQ training curriculum and ensure training is assigned to the appropriate CPMQ team.
  • Lead and embed the process for collating, trending and interpretation of quality data for actionable insights including the identification of systematic quality compliance risks and implementation of robust mitigation plans
  • Ensure maintenance of the dashboards to monitor the health of the QMS and proactively monitor and share across CPMQ the compliance metrics for CPMQ activities e.g. audit, inspection, QE, CAPA.
  • Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key priority topics and presentations are captured and effectively communicated.
  • Ensure that risks captured on the CPMQ risk register are evaluated and escalated to the Quality council and RDQ LT as applicable
  • Drive the implementation of the lessons learnt framework across CPMQ
  • Provide expert guidance to the CPMQ team on quality compliance activities.
  • Provide guidance and support to GCP, PV Health Authority inspections including logistics.
  • Present insights to the health of the QMS to CPMQ and to our stakeholders.
  • Represent CPMQ in Global Quality / R&D Quality process and system improvement initiatives.
  • Engage, share and embed best practices into learning opportunities across CPMQ teams and evaluate need for new / revised processes, tools and training solutions.
  • Act as Steward of the QMS within CPMQ (e.g. Quality Events, Serious Breach, Change Control, Risk Register, Regulatory Intelligence, Gap Assessment, Audits, Inspections, CAPA, SOP management, training assignment etc)
  • Education, Behavioural Competencies and Skills :

  • BSc in a scientific or allied health / medical field (or equivalent degree).
  • Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality / Compliance.
  • Advanced knowledge of pharmaceutical development, medical affairs and GCP / GVP regulations including FDA, EU, MHRA, PMDA and ICH.
  • Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting / leading regulatory inspections, investigations and remediation activities on a global level.
  • Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
  • Skilled in managing global, cross-functional projects.
  • Successful management of business transformation / change management initiatives e.g. quality system integration, outsourcing strategy etc
  • Excellent communication skills to convey message. Exceptional active listening skills to understand the needs and concerns of others, which is crucial for finding win-win solutions.
  • Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions.
  • Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.
  • Fluency in written and spoken English, additional language skills a plus.
  • Physical Demands :

  • Routine demands of an office-based environment
  • Travel Requirements :

    Willingness to travel to various meetings, including overnight trips. Some international travel may be required.

    Takeda Compensation and Benefits Summary :

    We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

    For Location : Boston, MA

    U.S. Base Salary Range : $153,600.00 - $241,340.00

    The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and / or long-term incentive s. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

    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.

    Locations

    Boston, MA

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time

    Job Exempt : Yes

    It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

    serp_jobs.job_alerts.create_a_job

    Director Compliance • Boston, MA, US

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Director, Compliance

    Director, Compliance

    Soteria Reinsurance Ltd.Boston, MA, United States
    serp_jobs.job_card.full_time
    Job Description : ## • •The Role • •As a Director within the Fidelity Enterprise Services Compliance team, you will serve as a trusted business partner promoting a culture of commitment to compliance, r...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Portfolio Compliance Director

    Portfolio Compliance Director

    Loomis, Sayles & CompanyBoston, MA, United States
    serp_jobs.job_card.full_time
    Loomis Sayles is a performance-driven active asset management company that seeks to identify exceptional investment opportunities on behalf of institutional and retail clients worldwide.We believe ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Labor Compliance

    Director, Labor Compliance

    NexampBoston, MA, US
    serp_jobs.job_card.full_time
    Do you want to be a part of the clean energy movement? Are you passionate about improving our environment for this generation and those to follow? Are you ready to take on new challenges and collab...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director Compliance Business Partner Pain Field Force Central (Remote / Hybrid)

    Associate Director Compliance Business Partner Pain Field Force Central (Remote / Hybrid)

    VertexBoston, MA, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Associate Director, Compliance Business Partner Us Pain Field Force.Vertex is a transformative biotechnology company that creates new possibilities in medicine to transform diseases and improve peo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director, Compliance Business Partner

    Associate Director, Compliance Business Partner

    Galderma Pharma S.ABoston, MA, United States
    serp_jobs.job_card.full_time
    Associate Director, Compliance Business Partner page is loaded## Associate Director, Compliance Business Partnerlocations : Bostonposted on : Posted Todayjob requisition id : JR015505Galderma is...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Corporate Compliance, North America

    Director, Corporate Compliance, North America

    WerfenBedford, MA, United States
    serp_jobs.job_card.full_time
    Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States.Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specia...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director, Regulatory Compliance

    Associate Director, Regulatory Compliance

    Alnylam PharmaceuticalsCambridge, MA, United States
    serp_jobs.job_card.full_time
    The Associate Director, Regulatory Compliance will help develop and drive department-wide global regulatory compliance strategies, with input from key program, Regulatory, Quality and CMC stakehold...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director Compliance Business Partner Pain Field Force West (Remote)

    Associate Director Compliance Business Partner Pain Field Force West (Remote)

    Vertex PharmaceuticalsBoston, MA, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Associate Director Compliance Business Partner Pain Field Force West (Remote) page is loaded## Associate Director Compliance Business Partner Pain Field Force West (Remote)locations : Boston, MAti...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director, PSPV Compliance & Analyticsl

    Associate Director, PSPV Compliance & Analyticsl

    eTeamCambridge, MA, US
    serp_jobs.job_card.full_time
    Associate Director, PSPV Compliance & Analytics.Location : Remote (Cambridge, MA).Objective / Purpose : Describe at the highest level the team where this job sits and how this role will contribute to...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Compliance Director

    Compliance Director

    Codman Square Health CenterBoston, MA, US
    serp_jobs.job_card.full_time
    Reporting to the Chief Operating Officer this position is responsible for developing and coordinating compliance programs that monitor operational and programmatic compliance.This position for the ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Compliance ((Must reside in Massachusetts))

    Director, Compliance ((Must reside in Massachusetts))

    Molina HealthcareBoston, MA, US
    serp_jobs.job_card.full_time
    Focus on the core content of the job post, removing all extra metadata, navigation mentions, and redundant headers.Keep the content beautiful and condensed, removing any extra spacing, website cook...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director Compliance Business Partner Pain Field Force Central (Remote / Hybrid)

    Associate Director Compliance Business Partner Pain Field Force Central (Remote / Hybrid)

    Vertex PharmaceuticalsBoston, MA, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Associate Director Compliance Business Partner Pain Field Force Central (Remote / Hybrid) page is loaded## Associate Director Compliance Business Partner Pain Field Force Central (Remote / Hybrid)locat...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director, Compliance Business Partner

    Associate Director, Compliance Business Partner

    GaldermaBoston, MA, US
    serp_jobs.job_card.full_time
    Associate Director, Compliance Business Partner.Reporting to the US Head of Ethics and Compliance, the Associate Director, Compliance Business Partner will play a critical role in managing and enha...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Compliance Technology & Operations

    Director, Compliance Technology & Operations

    Manulife Insurance MalaysiaBoston, MA, United States
    serp_jobs.job_card.full_time
    Nous utilisons des • •pour fournir des statistiques qui nous aident à vous offrir la meilleure expérience sur note site.Vous y trouverez des renseignements sur les témoins, ou vous pouvez les désac...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Compliance Governance and Oversight - Fidelity Digital Assets

    Director, Compliance Governance and Oversight - Fidelity Digital Assets

    Fidelity Investments Inc.Boston, MA, United States
    serp_jobs.job_card.full_time
    As a member of the Fidelity Digital Assets, LLC ("FDA") Compliance team, this role will serve as an informed and trusted business partner, who promotes an environment of ethical conduct and dedicat...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director Compliance Business Partner Pain Field Force West (Remote)

    Associate Director Compliance Business Partner Pain Field Force West (Remote)

    VertexBoston, MA, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Associate Director, Compliance Business Partner Us Pain Field Force.Vertex is a transformative biotechnology company that creates new possibilities in medicine to transform diseases and improve peo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Governance Risk and Compliance Associate Director

    Governance Risk and Compliance Associate Director

    DTCCBoston, MA, US
    serp_jobs.job_card.full_time
    Focus on the core content of the job post, removing all extra metadata, navigation, and redundant headers.Keep the formatting beautiful and high signal to noise ratio.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    AVP, Compliance Technology & Operations

    AVP, Compliance Technology & Operations

    ManulifeBoston, MA, US
    serp_jobs.job_card.full_time
    AVP Compliance Program Integration.Manulife is seeking a strategic and results-driven AVP to join the Compliance Technology & Operations (CT&O) function. Within CT&O, the AVP will lead the Complianc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days