Manager, GCP Compliance and Inspection Strategy - REMOTE
Company: Takeda Pharmaceuticals
Location: Santa Fe
Posted on: January 27, 2023
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 Takedas Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionREMOTE
OPPORTUNITYOBJECTIVES /PURPOSE:
- 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 quality
event/deviation process, CAPA development, and effectiveness check
tracking
- Champion change for clinical trial delivery
projectsACCOUNTABILITIES:Inspection/ 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 with the team, 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
team members
- Be the functional area compliance contact for Quality led
internal audits and regulatory inspections
- Active participation on Quality Inspection meetings, ensuring
timely completion of deliverables following agreed upon
timelines
- Work with subject matter experts and Quality in preparation for
audit and inspection implementation and follow-upCompliance and
Deviation Management
- Manage quality investigations with teams to determine root
cause and overall impact
- Support study execution teams on compliance to clinical trial
delivery SOPs; manage non-compliance
- Identify and highlight risks within project(s) and escalate.
Implement mitigation and escalation strategies for projects to
address risks
- Manage CAPA, EC tracking for supported
- Manage non-compliance including deviation determination,
documentation, collaborating with QualityEDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS :
- 4+ years clinical research experience in pharmaceutical or
biotechnology field
- Solid knowledge of clinical trial management and GCP compliance
processes
- Experience with negotiations and collaborative team building
with non- direct reports and other partners is required
- Solid knowledge of regulatory requirements governing clinical
trials and industry best practices
- Minimum Bachelor's degree, MS or equivalent in scientific
field
- Solid knowledge of drug development and clinical trial
processes, including related standards and documents.Base Salary
Range: $130-150K, based on candidate professional experience level.
Employees may also be eligible for Short Term and Long-Term
Incentive benefits as well. Employees are eligible to participate
in Medical, Dental, Vision, Life Insurance, 401(k), Charitable
Contribution Match, Holidays, Personal Days & Vacation, Tuition
Reimbursement Program and Paid Volunteer Time Off.EEO
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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time#LI-Remote
Keywords: Takeda Pharmaceuticals, Santa Fe , Manager, GCP Compliance and Inspection Strategy - REMOTE, Executive , Santa Fe, New Mexico
Didn't find what you're looking for? Search again!
Loading more jobs...