Associate Director, Clinical Quality Compliance

Vor 4 Tagen

Zürich, Zürich, Schweiz Takeda Vollzeit

Description

Job Title : Associate Director, Clinical Quality Compliance

Location : Cambridge, MA

About the role:

As the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. You will maintain a state of control by implementing monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is and aligned with applicable regulations. You will report to and act as a strategic expert to the Head of GCP Quality Compliance in developing GCP Compliance strategies, in managing the operational activities of and building capabilities within the GCP Compliance function and in ensuring agreement on the CPMQ vision.

How You Will Contribute:

Partner with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating improvement that is in consideration of Takeda's values and priorities.

Lead the clinical trial delivery system inspection readiness program, including the implementation of a strategy. Engage with relevant responsibilities and partners to ensure inspection readiness, driving accountability and transparency. Function include Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal. Provide insights to latest requirements, operational and compliance metrics and storyboards, identify quality and compliance inspection risks, and provide tactical directions in the mitigation. Host GCP inspections, and provides strategic direction to relevant responsibilities and Subject Matter Experts (SME). Ensure a communication plan is in place, that enables knowledge sharing of insights and risks. Communicate the progress of inspections daily, summarizing the inspection activities and potential observations and mitigation activities. And timely escalates to management. Lead the inspection response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant partners, at the right levels and submitted on time. Provide input to response to ensure the impact is thoroughly assessed, appropriate cause is identified, and, measurable, achievable, time-bound CAPAs are developed. Oversee the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigates and escalates any risks. Ensure appropriate effectiveness checks are developed for relevant inspection CAPAs. Provide input to the effectiveness check plans, and reviews and approve outcome. Be a Subject Matter Expert (SME) on the Clinical Quality Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control. Represent Clinical Quality Compliance in these topics in inspections. Support and provide relevant guidance to other other non-GCP specific inspections (e.g., GVP, GMP). Lead complex quality investigations improving the clinical trial delivery systems. Provide Quality Leadership for other quality investigations ensuring the right partners are engaged in impact assessment, root cause analysis and CAPA development. Develop lessons learned from on regulatory inspections, and quality investigations. Promote knowledge management. Lead improvements projects that ensure a compliant quality systems in the clinical trial delivery quality systems. Approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered. Escalates issues of potentially critical non-compliance and lack of urgency in remediation to senior management. Analyze results, quality issues and investigation to identify applicable trends and to promote a state of compliance. Develop and monitor relevant metrics and Main Performance/Quality Indicators (KPI/KQI). Mitigates, communicates, and escalates any risks flagged by the metrics/KQIs, ensuring actions are commensurate to the risk and timely. Drive the development and execute the strategy to understand the health of the clinical trial delivery quality system (i.e. risk register, KPIs). Contribute to any relevant quality and compliance governance in Takeda, including the and the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements and successes.

What you bring to Takeda:

BSc in a scientific or allied health/medical field (or equivalent degree).

Minimum of 10 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 5 years of experience in GCP Quality/Compliance. Experience with pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH. Experience must include successful implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level. Experience managing complex organizational compliance issues and in implementing organization-wide compliance projects.

Important Considerations:

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:

May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection. 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,. 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.

#GMSGQ #ZR1 #LI-MA1

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:

$149,100.00 - $234,300.00

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 attained, 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-termincentives. 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

Locations

Boston, MAZurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

  • Clinical Research Associate Position

    Vor 5 Tagen

    Zürich, Zürich, Schweiz Syneos Health, Inc. Vollzeit

    We are seeking a skilled Clinical Research Associate to join our team in Switzerland. As a key member of our FSP, you will be responsible for monitoring and site management activities for Phase I-IV clinical research projects.Your primary focus will be on assessing the progress of clinical projects at assigned investigative/physician sites, ensuring...

  • Clinical Research Associate

    Vor 2 Tagen

    Zürich, Zürich, Schweiz Syneos Health, Inc. Vollzeit

    Syneos Health, Inc. is a leading biopharmaceutical solutions organization accelerating customer success. We develop and deliver innovative therapies to patients worldwide, ensuring high-quality clinical research practices in all our projects.Job Description:The Clinical Research Associate (CRA) will be responsible for monitoring and site management...

  • Pharmaceutical Project Coordinator

    Vor 2 Tagen

    Zürich, Zürich, Schweiz Syneos Health, Inc. Vollzeit

    Join Syneos Health, Inc. as a Clinical Research Associate and contribute to the development and delivery of innovative therapies. This role involves monitoring and site management activities for Phase I-IV clinical research projects.Responsibilities:Monitor and manage clinical research sitesEnsure regulatory compliance and quality standardsCollaborate with...

  • Clinical Research Associate Professional

    Vor 3 Tagen

    Zürich, Zürich, Schweiz Syneos Health Vollzeit

    **Job Overview**Syneos Health, a leading biopharmaceutical solutions organization, seeks a highly skilled Clinical Research Associate to join our team. As a key member of our FSP client-dedicated team in Switzerland, you will be responsible for performing monitoring and site management activities for Phase I-IV clinical research...

  • Associate Director of Growth Initiatives

    Vor 2 Tagen

    Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    About the PositionWe are looking for a Senior Manager of Business Development to join our Strategic Resourcing Division (SRS) in Switzerland. As Associate Director of Business Development, you will focus on resourcing consultancy services and FSP Solutions.Your contributions will be instrumental to the company's ongoing success as we continue to...

  • Global Clinical Research Manager

    Vor 2 Tagen

    Zürich, Zürich, Schweiz Syneos Health, Inc. Vollzeit

    Syneos Health, Inc. seeks a skilled Clinical Research Associate to join our team. As a CRA, you will be responsible for performing monitoring and site management activities for global clients.Job Summary:This role involves working closely with project teams and site personnel to ensure timely completion of clinical trials.Key Responsibilities:Monitoring and...

  • Associate Director

    Vor 2 Tagen

    Zürich, Zürich, Schweiz Aequor Consulting GmbH Vollzeit

    Aequor Consulting GmbH is a leading consulting firm specializing in treasury technology and risk management. We are seeking an Associate Director - Treasury Solutions to join our team.About the RoleIn this role, you will lead complex, transformational initiatives in global treasury management, working closely with clients to advise on key treasury, risk...

  • Clinical Operations Specialist

    Vor 3 Tagen

    Zürich, Zürich, Schweiz Zs Associates Vollzeit

    ZS Associates partners with clients to design and deliver solutions to help them tackle a broad range of business challenges.Our teams work on multiple projects simultaneously, leveraging advanced data analytics and problem-solving techniques.Our recommendations and solutions are based on rigorous research and analysis underpinned by deep expertise and...

  • Regulatory Compliance Director

    Vor 2 Tagen

    Zürich, Zürich, Schweiz gategroup Vollzeit

    We are looking for a highly skilled Regulatory Compliance Director to oversee the Environmental, Health and Safety program for the unit. The ideal candidate will have a background in EHS and demonstrated career progression, with a minimum of 5 years of professional experience in the field.The Regulatory Compliance Director will be responsible for developing,...

  • Associate Director

    vor 1 Woche

    Zürich, Zürich, Schweiz Takeda Vollzeit

    Description Associate Director - Global Medical Excellence Lead PURPOSE: Partner with Takeda business units to drive strategic and operational alignment of Medical Excellence programs that are aligned with overall corporate goals and objectives. Ensure successful development and execution of training designed to build functional skills and...

  • Director of Quality and Compliance

    Vor 2 Tagen

    Zürich, Zürich, Schweiz ANYbotics Vollzeit

    Key ResponsibilitiesThe ideal candidate will have a proven track record in implementation and operation of ISO 9001 or other relevant quality management frameworks. They will possess strong communication skills, excellent stakeholder management, and experience in auditing processes and materials.As a leader, they will be responsible for setting up and...

  • Senior Clinical Development Manager

    Vor 2 Tagen

    Zürich, Zürich, Schweiz headcount | recruitment driven by scientists Vollzeit

    Senior Clinical Development ManagerOur MissionWe strive to make a significant impact in the biotech industry by delivering innovative vaccines that address unmet medical needs. We believe in fostering a collaborative environment that encourages teamwork and open communication.Key ResponsibilitiesThe ideal candidate will lead the clinical team, develop...

  • Compliance and Quality Manager

    Vor 5 Tagen

    Zürich, Zürich, Schweiz Experis Switzerland Vollzeit

    About the Role:The Trading Entity Compliance QA Associate will be responsible for ensuring that all regulatory requirements are met. This includes supporting the establishment of procedures and processes, executing self-inspections, and ensuring approval of suppliers and customers.Responsibilities:Ensure all requirements to maintain the Establishment License...

  • Compliance and Quality Lead

    Vor 2 Tagen

    Zürich, Zürich, Schweiz EPM Scientific - Phaidon International Vollzeit

    EPM Scientific - Phaidon International prioritizes quality and compliance in the development and manufacturing of medical devices.We are seeking a highly skilled Compliance and Quality Lead to oversee our quality management systems and ensure regulatory compliance.Responsibilities:Maintain and implement quality systems (ISO 13485, FDA, EU MDR).Conduct audits...

  • R&D Clinical Quality Expert

    Vor 3 Tagen

    Zürich, Zürich, Schweiz Zs Associates Vollzeit

    ZS Associates offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth, and professional development.We are committed to giving our employees a flexible and connected way of working.The Business Development Lead will establish or maintain ongoing client relationships with key business...

  • Equity Associate Director

    vor 1 Tag

    Zürich, Zürich, Schweiz ACL Partners Vollzeit

    A seasoned professional is sought by ACL Partners to fill the position of Equity Associate Director. As part of a high-performing team, the selected candidate will be responsible for spearheading investment initiatives and driving growth across diverse industries in Europe.Key Accountabilities:Leads financial analysis and modeling efforts to inform...

  • Regulatory Compliance Officer

    Vor 3 Tagen

    Zürich, Zürich, Schweiz ITech Consult AG Vollzeit

    Regulatory Compliance Specialist:ITech Consult AG is seeking a highly skilled Regulatory Compliance Specialist to join our team. This key role will be responsible for ensuring compliance with regulatory requirements and industry standards throughout the project lifecycle.Main Responsibilities:Develop and implement regulatory compliance strategies to ensure...

  • Clinical Operations Specialist

    Vor 3 Tagen

    Zürich, Zürich, Schweiz Planet Pharma Vollzeit

    About the RoleWe are seeking an experienced Clinical Trial Manager to join our team at Planet Pharma. In this role, you will be responsible for the day-to-day operations of clinical trials and the clinical trial implementation in Europe and globally.Ensure the successful execution of clinical study projects by contributing to project planning, site...

  • Clinical Research Project Manager

    Vor 3 Tagen

    Zürich, Zürich, Schweiz ITech Consult AG Vollzeit

    Job Description:We are seeking a Clinical Research Project Manager to join our team at ITech Consult AG. This key role will be responsible for managing the overall delivery of clinical research projects, ensuring timely completion and exceeding customer expectations.Main Responsibilities:Manage multiple projects simultaneously, prioritizing tasks and...

  • Compliance Officer

    Vor 6 Tagen

    Zürich, Zürich, Schweiz Randstad Vollzeit

    About the RoleAs a Compliance Officer - Quality Management, you will be responsible for ensuring that our laboratory services meet the highest standards of quality and compliance. This will involve managing the document control system, developing and implementing quality policies and procedures, and training staff on quality management systems. You will also...