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13 days old

Investigation Management Lead

Kelly Services
Lexington, MA 02421
Kelly is hiring a **Investigation Management Lead** for one of our pharmaceutical clients.


+ 1 year duration to start

+ $50-$66/hr

+ Remote


Investigation Management Lead

*This is a Quality/Investigations based role as a strong SME in the area of GxP investigations*


**OBJECTIVES/PURPOSE**

Accountable for leading significant site/regional investigations, driving to determine root cause, product impact, CAPA and timely investigation closure.

Supporting the Investigation Capability Building Must Win Battle including development of increased investigation capabilities across sites/regions network


**SCOPE**

Ensures effective investigation management for significant Quality events; Interacts with a broad range of internal stakeholders to ensure complex events/investigation are efficiently managed, escalated if required and progressed to closure in a timely manner

Develops and rolls out investigation training to build sustainable investigation capabilities across the Takeda site/regions


**ACCOUNTABILITIES**

Accountable for driving significant site/regional investigation to root cause, determination of product impact, scope definition, CAPA & CAPA effectiveness

Accountable for developing and delivering a comprehensive training program to build sustainable cross functional investigation capabilities across sites/regions

Responsible for support site remediation where significant compliance deficiencies are identified.


**DIMENSIONS AND ASPECTS**

Knowledge and understanding of Biologics, Plasma and Small Molecule manufacturing therapeutic areas as well as scientific advances and modalities for treating diseases.

Deep knowledge and understanding of international heath authorities compliance requirements


**Leadership**

Ability to lead significant investigations, drive to root cause, product impact, CAPA and timely investigation closure.

Ability to lead and engage in complex investigations and propose sound, scientific and compliant resolutions

Ability to support increased organisational investigational capability across sites, regions and OpUs as required.


**Decision-making and Autonomy**

A member of the Knowledge Management team contributing to the execution of strategic plans for the function and development of annual goals

Responsible for supporting the increased investigation capabilities across sites/regions and OpUs.


**Interaction**

Key interactions across all manufacturing and Quality regional and operating unit teams

Key interactions with Supply & Business Excellence to support increased investigation capabilities across the sites/regions/OpU

Key Interactions with the OpU and Region Compliance Leads & extended Global Compliance & Systems team.

Key interactions with the incident management team to ensure timely escalation of significant events/incident and regulatory reporting if required


**Innovation**

A firm grasp of industry, scientific and regulatory trends, understands market conditions, and leverages innovation to evolve Takedas profile to become the model for the industry


**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:**


**Education / experience**

Scientific degree (BSc, MSc)

10+ years of experience in the pharmaceutical industry working within the Quality organization

Experience working in an international environment

Knowledge and experience of BioPharmaceutical Manufacturing and the management of complex investigations

Deep knowledge and understanding of international heath authorities compliance requirements

Fluent in written and spoken English


**Core Competencies / Skills**

Critical Thinking

Current on local and global regulations

Digital and analytical skills

Problem solving methodologies, e.g. fishbone, DMAIC

Strong communication skills engaging stakeholders: site, business, network, company, regulators

Risk identification, evaluation and management

Continuous improvement


**Leadership Behaviors**

Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust

Creating the environment that inspires and enables people

Focusing on the few priorities and provide superior results

Elevating site/regional/OpU investigation capabilities for now and the future


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-09-06 Expires: 2021-10-07

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Investigation Management Lead

Kelly Services
Lexington, MA 02421

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