Associate Director, Gcp Compliance

8+ years

149,100.00 - 234,300.00

Remote

10 Dec. 31, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, GCP Compliance

Location: Remote (Massachusetts)
Company: Takeda
Job ID: R0138690
Date Posted: November 13, 2024

Job Overview:

Takeda is looking for an Associate Director, GCP Compliance to join their team remotely, reporting to the Director, GCP Compliance. This role will play a key part in overseeing compliance management related to clinical trials, ensuring adherence to Good Clinical Practice (GCP), and driving proactive risk-based compliance assessments. The ideal candidate will have a strong background in clinical trial delivery and compliance, with a focus on quality assurance, audit management, and risk mitigation.

Key Responsibilities:

Compliance Management:
- Oversee quality events/deviations including root cause analysis, CAPA development, and implementation.
- Facilitate internal audits for clinical trial functions, including managing audit responses and CAPA development.
- Advise study teams on compliance issues and collaborate with Quality Assurance to ensure proper audit scopes.
Compliance Assessments:
- Proactively identify risks within processes or therapeutic areas and develop assessments to address compliance.
- Advise functional areas on mitigation and escalation strategies to address risks and issues.
- Lead assessments related to GCP Quality Plans, CAPAs, and adherence to compliance goals.
GCP Compliance Metrics and Reporting:
- Build relationships with clinical trial delivery functions to track performance metrics related to GCP compliance.
- Develop and track KPIs, metrics, and dashboards for process quality and compliance.
Team Leadership and Development:
- Train, coach, and mentor team members to foster a culture of innovation and continuous improvement.
- Serve as a role model for Takeda’s values and promote a positive and productive work environment.

Qualifications:

Education:
- Bachelor's Degree (Life Sciences preferred).
Experience:
- 8+ years in the pharmaceutical industry or clinical research organization, with at least 6 years in compliance or clinical study management.
- Experience leading projects and collaborating with cross-functional teams.
- Global or international experience is required, with a strong ability to work across locations.
Skills:
- Strong strategic thinking and planning capabilities.
- Experience in clinical development with direct exposure to novel approaches in clinical trials.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
- Excellent communication and collaboration skills.

Compensation and Benefits:

U.S. Base Salary Range:
$149,100 - $234,300 per year, depending on experience.
Benefits:
- Eligible for short-term and long-term incentives.
- Medical, dental, and vision insurance.
- 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, and holidays.
- Up to 120 hours of paid vacation and up to 80 hours of sick time per year.

Diversity and Inclusion:

Takeda is committed to building a diverse workforce and providing equal employment opportunities to all employees. We celebrate diversity and ensure that all individuals have an opportunity to succeed, regardless of their background or identity.

Join Takeda and contribute to our mission of providing better health and a brighter future for people around the world.

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Associate Director, Gcp Compliance

Job Description

Job Title: Associate Director, GCP Compliance

Job Overview:

Key Responsibilities:

Qualifications:

Compensation and Benefits:

Diversity and Inclusion:

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