Senior Manager, Process Training and Compliance

Company: Takeda Pharmaceutical
Location: Clifton
Posted on: November 13, 2021

Job Description:

By clicking the -Apply- button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title:Senior Manager- (Clinical Trials) Process Training and ComplianceTakedaTakeda 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 guided by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.Key Accountabilities:As the Sr. Manager, Process Training and Compliance you will report to the Director, GCP Process Excellence, Compliance and Inspection Strategy. You will manage study execution teams in GCP inspection readiness and inspection activities. Be the clinical trial delivery compliance function on Quality led inspection preparations, internal audits, quality events, and regulatory inspections Ensure clinical trial delivery compliance by managing GxP training compliance for supported areas including learning plan coordination and management. Ensure clinical trial delivery compliance by overseeing quality event/deviation process, CAPA development and effectiveness check tracking. You will maximize clinical trial delivery process efficiency and regulatory compliance by managing SOP/QMS document development for supported areas with relevant SMEs, senior leadership, partners, and Quality and driving their implementation. Increase compliance effectiveness by guiding implementation of global plans. You will provide direct change management support for clinical trial delivery projects.Responsibilities:

• Manage Inspection and Audits Capability
• Manage study execution teams in regulatory inspection readiness activities focused on clinical trial delivery process and functional area compliance in partnership with Quality
• Coordinate storyboard development focusing on high risk and high impact areas as part of inspection readiness activities.
• Create documentation, such as plans, timelines, progress reports, measuring compliance and quality communicating actions to partners
• Be a functional area compliance contact for Quality led internal audits and regulatory inspections
• Active participation on Quality Inspection meetings, ensuring completion of deliverables following agreed upon timelines
• Work with experts and Quality in preparation for audit and inspection implementation and follow-up
• Compliance and Deviation Management
• Support study execution teams on compliance to clinical trial delivery SOPs; manage non-compliance
• Identify and highlight risks within project(s) and escalate. Develop mitigation and escalation strategies for projects to address risks
• Manage CAPA, EC tracking for supported departments
• Manage non-compliance including deviation determination, documentation, working with Quality
• Maximize clinical trial delivery process efficiency and regulatory compliance by overseeing GxP training compliance for supported areas
• Coordinate and maintain training plans in Learning Management System (LMS) for supported areas
• Analyze and build high value training and communications programs with functional area goals and plans
• Manage customer communication in relation to GxP training and training compliance
• Provide training orientations to new employee on training curricula and systems
• Represent clinical trial delivery supported functions on company-wide/R&D-wide training projects
• Active participation on Quality training forums and process improvement activities
• QMS and Process Management; Process Improvement
• Manage Quality Management System (SOP) Development process for supported areas with relevant SMEs, partners, and Quality; ensure consistency in document portfolio within QMS
• Maximize clinical trial delivery process efficiency and regulatory compliance by leading process improvement activities and programs in global clinical trial delivery functions
• Be the clinical trial delivery SOP and Process expert for inspections and internal auditsEDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:
  • 8+ years' clinical research experience in pharmaceutical or biotechnology field
  • Solid knowledge of clinical trial management and GCP compliance processes
  • Experience in negotiations and collaborative team building with non- direct reports and other team members is required
  • Comprehensive knowledge of Regulatory requirements governing clinical trials and industry best practices
  • Bachelor's degree or equivalent in scientific field
  • Advanced knowledge of drug development and clinical trial processes, including related standards and documents.
  • Good knowledge of clinical development training management, methods, and toolsThis posting excludes CO Applicants.Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. You are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the department /Function for which they have applied.WHAT TAKEDA CAN OFFER YOU:
    • 401(k) with company match and Annual Retirement Contribution Plan
    • Tuition reimbursement Company match of charitable contributions
    • 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 ProgramsEEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Clifton , Senior Manager, Process Training and Compliance, Executive , Clifton, New Jersey