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Director/Senior Director, Quality Control

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

Job Description:

Director/Senior Director, Quality Control Company: HCPro, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Director/Senior Director, Quality Control

BM Director/Senior Director, Quality Control Director/SeniorDirector, Quality Control

Cambridge, MA

Requisition Number: QA20-903

At Blueprint Medicines, we are creating a blueprint for thefuture of healthcare. We are a leading company in the personalizedmedicine revolution by focusing on delivering new medicines thatare targeted to the genetic driver of disease. We do this byleveraging our one-of-a-kind drug discovery platform to discover,develop and work to bring highly-selective kinase inhibitors topatients globally. This prolific scientific platform has enabledBlueprint Medicines to build a pipeline of novel therapies thatspan three distinct areas of medicine; genomically defined cancers,rare diseases and cancer immunotherapy.

This position will oversee the QC function at BlueprintMedicines and support the development and implementation ofGMP/GLP/GCLP quality systems to ensure that Blueprint’s testing andcontrol strategy is in compliance with US and internationalregulations, laws, and guidelines that oversee the manufacturingand testing of investigational clinical trial materials. Reportingto VP of Quality, the Director of QC will provide oversight ofthird party GMP, GLP, and GCLP contract testing labs including butnot limited to technical transfer, method qualification andvalidation as well as routine GMP testing (in process, lot releaseand stability testing). The Director of QC will support theportfolio of clinical development and commercial programs to ensuretimely delivery of clinical and commercial supplies and willassemble, review and trend release, IPC, and stability data,generating reports as necessary to support specification and expirysetting. Analytical method support will include but will not belimited to continuous monitoring of method performance (e.g.,control charting, invalid rates, etc.), investigation/OOSmanagement, data integrity reviews, and authoring and/or review ofrelevant sections of IND/IMPD and NDA/MAA and APQR (i.e., IPC/rawmaterials testing and control, method validation, specifications,batch analysis, reference standard, and stability).

Responsibilities :

Ensure successful technical transfer, method validation androutine GMP, GLP, and GCLP testing in collaboration with AnalyticalDevelopment and external QC test labs,

Support the development and management of specifications forin-process, release and stability testing programs,

Ensure all GMP, GLP, and GCLP testing is conducted in accordancewith SOPs, compendia, approved methods, and the company’s andregulatory agencies’ policies and procedures,

Direct aspects of contract GMP testing labs including finishedproduct, in-process, raw material, and stability testing,

Support the development and management of QC systems and SOPs,such as LIMS, sample management, shipping, release testing andlaboratory investigations,

Oversee the stability program and manage product expiryassignments,

Ensure maintenance of reference standards,

Prepare, analyze and trend QC data, generating stability andother trending reports as necessary,

Support QC deviations, investigations, analytical methodperformance trending and work with external testing laboratories onroot cause analysis and investigation actions,

Participate in regulatory agency inspections, and assists inobservational resolutions, as needed,

Author appropriate sections of regulatory filings, including butnot limited to IND/IMPD and NDA/MAA, and perform data integrityreviews as necessary.

Qualifications:

A Bachelor’s Degree in Chemistry, Biochemistry or a relateddiscipline with at least 10 years of relevant industryexperience,

Experience validating methods and monitoring commercial methodperformance,

Experience in authoring method, specification, referencestandard, and stability sections of regulatory submissions,

Experience drafting protocols and technical reports and QCpolicies and procedures required,

Experience with statistical analysis of analytical data andstability studies preferred,

Ability and desire to work in a fast-paced, start-upenvironment,

Strong collaboration, team-building skills and communicationskills

Independently motivated and detail-oriented with goodproblem-solving ability,

Demonstrated effective time management skills

Sound judgment and commitment to ethical conduct

Must be willing to travel domestically and internationally up to25%

Capabilities :

Adaptability/Flexibility – The ability to adapt to workingeffectively within a variety of situations; adapts enthusiasticallyto organizational change and to changes in job demands.

Communication and Teamwork – Ability to effectively expressideas in written and oral context; to work co-operatively withothers; genuine desire to be a part of a team and contribute toorganizational and team goals.

Effective Planning – Embedding discipline and thoroughness inour approaches.

Perseverance – Pursues tasks with energy, drive and initiative,even in the face of adversity; comfortable in a results-driven,highly accountable environment where you can make an impact.

Problem Solving – Ability to understand a situation or problemby breaking it down into smaller pieces using a systematic approachand to identify patterns and connections between situations thatare not obviously related.

Relationship Building – Builds productive working relationshipsacross a diverse spectrum of people.

Organizational Skills – Ability to handle multipleresponsibilities simultaneously and still meet high quality andtimeliness standards under pressure.

All qualified applicants will receive consideration foremployment without regard to race, color, religion, sex, sexualorientation, gender identity, national origin, disability, orstatus as a protected veteran.

WHO WE ARE:

Blueprint Medicines’ mission is to dramatically improve thelives of patients with genomically defined diseases. Our singularfocus is to use our deep understanding of the genetic blueprint ofcancer and other diseases driven by the abnormal activation ofkinases to craft highly selective medicines aimed at eradicatingthese diseases.

We don’t think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, andnew ways of thinking.

We know that what each and every one of us does matters and thatour success depends on our ability to work together. We believe weare at our best as a company when our employees are thriving andfoster a culture that provides opportunities to grow and developprofessionally, while also having fun.

Job Information

Job ID: 54554370

Location:

Cambridge, Massachusetts, United States

Position Title: Director/Senior Director, Quality Control

Company Name: Blueprint Medicines

Job Function: Clinical,

Quality Control

Job Type: Full-Time

Job Duration: Indefinite

Min Education: BA/BS/Undergraduate

Min Experience: 7-10 Years

Required Travel: 10-25%

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Keywords: HCPro, Inc., Cambridge , Director/Senior Director, Quality Control, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Woonsocket , Director/Senior Director, Quality Control, Other , Woonsocket, Rhode Island

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