Associate Director, Clinical Quality Assurance

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

Job Description:

Associate Director, Clinical Quality Assurance Company: Acceleron Pharma

Location: Cambridge

Posted on: September 12, 2020

Job Description:

National Postdoctoral Association Career Center AssociateDirector, Clinical Quality Assurance

AP Associate Director, Clinical Quality Assurance Acceleron is abiopharmaceutical company dedicated to the discovery, development,and commercialization of therapeutics to treat serious and rarediseases. Acceleron’s leadership in the understanding of TGF-betasuperfamily biology and protein engineering generates innovativecompounds that engage the body's ability to regulate cellulargrowth and repair.

Acceleron focuses its commercialization, research, anddevelopment efforts in hematologic and pulmonary diseases. Inhematology, REBLOZYL® (luspatercept-aamt) is the first and onlyerythroid maturation agent approved in the United States and Europefor the treatment of anemia in certain blood disorders. REBLOZYL ispart of a global collaboration partnership with Bristol MyersSquibb. The Companies co-promote REBLOZYL in the United States andare also developing luspatercept for the treatment of anemia inpatient populations of MDS, beta-thalassemia, and myelofibrosis. Inpulmonary, Acceleron is developing sotatercept for the treatment ofpulmonary arterial hypertension, having recently reported positivetopline results of the Phase 2 PULSAR trial.

For more information, please visit www.acceleronpharma.com.Follow Acceleron on Social Media: @AcceleronPharma andLinkedIn.

What’s in it for you?

The Associate Director of Clinical Quality Assurance (QA) willbe responsible for providing QA support of clinical programs atAcceleron. This individual will be the subject matter expert inGood Clinical Practice (GCP), develop standards and partner withClinical Operations, Regulatory, Biostatistics, Safety, MedicalResearch, Non-Clinical Development, and other functions toestablish and document risk-based GCP processes and procedures. TheAD of Clinical QA will ensure compliance with applicableregulations with regards to sponsor oversight of Acceleron’sclinical programs.

What will you be doing?

Serve as the GCP QA Program Lead while working with internal &external stakeholders to ensure overall compliance with theprotocol, study documents, and global regulatory requirements.

Serve as the expert GCP consultant for issue management & issueescalation, with a focus on critical and major quality events.

Assist in resolving compliance issues at clinical sites,clinical vendors, and laboratories; and provide assessment of theimpact of any deficiencies.

Work with internal customers and develop and execute strategicaudit plans based the specific program needs

Support the development and/or review of audit agendas, auditreports, and CAPA’s for external audits.

Support the internal audit program as needed.

Participate in preparations for regulatory inspections, whichmay include reviewing Inspection Readiness Planning, MockInspections, and risk-based management of program inspectionquality events.

Support investigational new drug applications, ex-US clinicaltrial applications (CTA), and related correspondence from globalregulatory authorities

Create or improve processes to ensure compliance with GCPregulations

Review/Revise/Author standard operating procedures (SOPs) asneeded

Requirements

What are we looking for?

GCP QA professional with late-stage program managementexperience and a proven track record of demonstrating goodjudgement & decision-making experience.

Ability to concisely present quality events and criticality tointernal stakeholders.

Excellent interpersonal, verbal, and written communicationskills with the ability to diplomatically address qualityissues.

Well-prepared, competent, and confident when interacting withsenior management, regulatory authorities, and internal andexternal partners

Analyze complex situations / issues and effectively communicatesituations / issues, along with potential recommendations, tovarious functional groups.

Experience with developing & implementing GCP QA systems,processes, and procedures.

Ability to remain objective/autonomous in implementing theQuality Program, while at the same time taking ownership andproactively working with the rest of the team to achieve thedesired quality objectives

Broad understanding of international regulations and guidancedocuments, with a focus on FDA & EMA regulations

Strong working knowledge of GCP for drug/device covering allphases of clinical study program (Phase I to IV).

Conducted GCP audits and actively participated in regulatoryinspections.

Strong experience in IND and CTA filings; NDA/BLA/MAA experiencestrongly preferred

Bachelor’s degree in a scientific discipline is required. Anadvanced degree is preferred

Minimum of 10-12 years of relevant experience in abiotech/pharmaceutical setting with at least 5 years of GCP QualityAssurance experience

How will you grow with us?

This candidate will advance Acceleron’s innovative pipelinethrough proactively developing and influencing quality specificstandards. As the pipeline progresses, this candidate will increasetheir strategic planning skills to align pipeline progression tothe regulatory climate and global footprint.

*In compliance with federal law, all persons hired will berequired to verify identity and eligibility to work in the UnitedStates and complete the required employment eligibilityverification document form upon hire.

*Recruiters - please do not send unsolicited resumes to thisposting.

FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:

Location:

Cambridge, Massachusetts, United States

Position Title: Associate Director, Clinical QualityAssurance

Company Name: Acceleron Pharma

Job Function: Quality Assurance

Job Type: Full-Time

Job Duration: Indefinite

View your connections at Acceleron Pharma LinkedIn 15800 CrabbsBranch Way, Rockville, Maryland 20855 (301) 984-4800

Keywords: Acceleron Pharma, Cambridge , Associate Director, Clinical Quality Assurance, Other , Cambridge, Massachusetts

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