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Clinical Quality Assurance Project Lead

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: ASSOCIATION OF CONTINGENCY

Location: Cambridge

Posted on: September 14, 2020

Job Description:

Network and Systems Professionals Association (NaSPA) ClinicalQuality Assurance Project Lead (AD)

T Clinical Quality Assurance Project Lead (AD) Clinical QualityAssurance Project Lead (Associate Director), Cambridge, MA

Are you looking for a patient-focused company that will inspireyou and support your career? If so, be empowered to take charge ofyour future at Takeda. Join us as a Clinical Quality AssuranceProject Lead/ Asc Dir in our Cambridge office.

Here, everyone matters and you will be a vital contributor toour inspiring, bold mission. As an Associate Director working onthe R&D Quality Assurance team, you will be empowered to leadClinical Quality Assurance (CQA) activities for assigned clinicaldevelopment programs, and a typical day will include:

OBJECTIVES:

Responsible for the management of audits, quality issues andinvestigations, and inspections. This position requires a depth ofunderstanding and significant experience in GCP and compliance,leadership, communication skills, and business acumen to conductresponsibilities independently.

Provide professional expertise and guidance on Good ClinicalPractice (GCP) and applicable regulations to clinical developmentteams to proactively identify compliance issues/risks and recommendmitigations

Liaise with various Takeda R&D functions and externalparties including contract auditors and investigator sites topromote a high level of quality and consistency across and withinprograms; develop the risk-based audit and compliance strategy forassigned programs; assist project teams in implementing correctiveand preventive actions; and enable teams to be inspection ready, insupport of a culture of sustainable compliance.

Independently manage domestic and international audits of sites,documents, databases, vendors or internal systems in compliancewith GCP and Takeda policies and procedures; assess impact of auditfindings on subject safety, data integrity, and businessoperations. Audits conducted require advanced auditing skills andmay involve technically complex assignments, including audits ofhigh-risk studies/vendors

ACCOUNTABILITIES:

Provide expertise in GCP compliance interpretation,consultation, training, and recommendations to assigned highpriority development program teams

Assume complex assignments on issues or studies where there isno precedent

Mentor and provide support to Manager level CQA personnel, asneeded

Develop and implement program-specific risk-based audit andcompliance strategy and manage audits of sites, documents,databases, vendors or internal systems in compliance with GCP andTakeda policies and procedures. Audits require advanced auditingskills and involve technically complex assignments. Assess impactof audit findings and other identified compliance risks to subjectsafety, data integrity, and business operations and escalatecompliance risks to CQA management. Ensure audit reports andcorrective actions are developed and completed within timelinesmandated in internal procedures

Lead investigations into significant quality issues, scientificmisconduct and serious breach of GCP; facilitate identification ofroot cause and development of appropriate corrective and preventiveactions; track actions and confirm effectiveness; ensure reportingof potential or confirmed violations to regulatory authorities.

Lead GCP health authority inspections; lead clinical developmentteams in preparation for announced inspections and provide GCPcompliance technical support during inspections of investigatorsites and Takeda. Facilitate appropriate and timely inspectionresponses and follow-up actions

Analyze, report, and present metrics for assigned programs todevelopment teams R&D, and Quality management; recommend anyrequired actions and monitor implementation.

Collaborate with Quality Compliance and Systems team to identifyand mitigate GCP quality and compliance issues with potentialimpact across multiple programs, Takeda sites, or functionalgroups.

Escalate systemic and/or critical problems and recommendappropriate solutions to senior management for immediate andlong-term resolution

Participate in due diligence activities and process improvementinitiatives as requested by management

May act as supervisor for temporary contractors

Requirements

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

BA/BS degree required; advanced degree preferred.

Minimum of 10 years of experience in the pharmaceutical,biotechnology or related health care industry.

Minimum 7 years of GCP-related Quality Assurance or relevantclinical trial experience.

Extensive knowledge and/or awareness of ICH GCP and applicableglobal regulations and guidance for clinical development

Advanced knowledge in the conduct and reporting of audits andthe translation of findings into corrective actions plans thatmitigate risks to the company, to safety and data integrity.

Collaborative team player with a positive attitude and abilityto think and act quickly to identify creative solutions to complexproblems

Strong technical writing skills; able to write qualitypositions, audit reports, and procedures.

Excellent communication skills with ability to negotiate andinfluence without authority in a matrix environment

Strong judgment, project management and decision-making skills;able to manage multiple projects and demanding timelines

Superior attention to detail and ability to analyse complexdata

LICENSES/CERTIFICATIONS:

GCP Quality Assurance registration/certification preferred

PHYSICAL DEMANDS:

Routine demands of an office-based environment

TRAVEL REQUIREMENTS:

Willingness to travel to various meetings and/or audits,including overnight trips. Some international travel may berequired.

Requires approximately 30% travel.

WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual Retirement ContributionPlan

Company match of charitable contributions

Health & Wellness programs including onsite flu shots and healthscreenings

Generous time off for vacation and the option to purchaseadditional vacation days

Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com

Job Information

Job ID: 54177674

Location:

Cambridge, Massachusetts, United States

Position Title: Clinical Quality Assurance Project Lead (AD)

Company Name: Takeda

Job Function: Quality Assurance

Job Type: Full-Time

Job Duration: Indefinite

Min Education: BA/BS/Undergraduate

Min Experience: 5-7 Years

Required Travel: 10-25%

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Clinical Quality Assurance Project Lead (AD)

Keywords: ASSOCIATION OF CONTINGENCY, Waltham , Clinical Quality Assurance Project Lead, Other , Cambridge, Massachusetts

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