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Compliance Operations Lead, Associate Director

7+ years
149,100.00 - 234,300.00
10 Nov. 27, 2024
Job Description
Job Type: Full Time Remote 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

The Clinical and Pharmacovigilance Quality (CPMQ) Process and Compliance Lead position at Takeda in Boston, MA, is a high-impact role for professionals dedicated to ensuring excellence in global quality processes and compliance. This position is central to fostering a quality-driven culture, implementing robust processes, and supporting continuous improvement within Takeda's clinical and pharmacovigilance teams.


Key Role Highlights

Objectives:

  • Embed and manage global R&D quality processes within CPMQ.
  • Proactively assess functional needs and lead process/system enhancements.
  • Drive change management, training, and process implementation.
  • Monitor the Quality Management System (QMS) health and address compliance risks.
  • Lead CPMQ initiatives for optimization and continuous improvement.
  • Serve as a subject matter expert in quality compliance and liaise with Global Quality teams.

Primary Responsibilities

  1. Process Development & Training:

    • Develop and implement functional processes and ensure alignment with regulatory and global requirements.
    • Create and deliver training solutions to support CPMQ processes and tools.
    • Manage the CPMQ training curriculum to ensure team readiness.
  2. Quality Management:

    • Lead the creation and interpretation of quality metrics and compliance data.
    • Oversee dashboards tracking QMS health and compliance metrics (e.g., audits, inspections, CAPAs).
    • Manage the CPMQ risk register and escalate risks appropriately.
  3. Continuous Improvement:

    • Implement lessons learned frameworks and share best practices across teams.
    • Drive transformation and business optimization projects.
  4. Regulatory Support:

    • Provide expertise for GCP and PV health authority inspections and audits.
    • Represent CPMQ in global quality initiatives, ensuring Takeda remains at the forefront of compliance.
  5. Cross-Functional Engagement:

    • Organize and manage Clinical and Pharmacovigilance Quality council meetings.
    • Collaborate with stakeholders to foster a culture of continuous improvement and quality excellence.

Candidate Profile

Education:

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

Experience:

  • 7+ years in the pharmaceutical industry, with 3+ years in GCP quality/compliance.
  • Proven track record in developing/implementing global audit programs and managing inspections.
  • Skilled in managing organizational compliance and implementing cross-functional initiatives.
  • Expertise in change management and quality system integration.

Skills:

  • Advanced knowledge of GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH).
  • Strong leadership, project management, and communication abilities.
  • Critical thinking and problem-solving expertise for global compliance challenges.
  • Fluency in English; additional languages are a plus.

Work Environment

This is an office-based position with occasional travel requirements, including international trips, for meetings and inspections.


Compensation and Benefits

  • Base Salary Range: $149,100 to $234,300, dependent on experience and qualifications.
  • Comprehensive benefits package, including medical, dental, vision insurance, 401(k) with company match, disability coverage, life insurance, and paid time off.
  • Opportunities for short-term and long-term incentives.

Diversity and Inclusion

Takeda is committed to fostering an inclusive environment and providing equal employment opportunities regardless of background or protected characteristics, in compliance with federal, state, and local laws.


If you're passionate about driving quality excellence and shaping the future of clinical and pharmacovigilance compliance, this role provides an ideal platform. Need assistance with your application or preparation?