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Associate Director, Software Engineering

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

Job Description:

Associate Director, Software Engineering Company: Takeda Pharmaceuticals North America, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Associate Director, Partnership Quality Lead Company: Takeda

Location: Cambridge

Posted on: July 14, 2020

Job Description:

By clicking the Apply button, I understand that myemploymentapplication process with Takeda will commence and that Iagree withTakedas Privacy Notice, Privacy Policy and Terms ofUse.JobDescriptionAre you looking for a patient-focused companythat willinspire you and support your career? If so, be empoweredto takecharge of your future at Takeda. Join us as an Asc DirPartnershipQuality Lead in our Cambridge office.

Here, everyone matters and you will be a vital contributor toourinspiring, bold mission. As an Asc Dir Partnership QualityLeadworking on the R&D Quality team, you will be empoweredtocoordinate the execution of the overall Internal SupplerAuditstrategy and R&D QA & Compliance (QA&C)Operationalobjectives, and a typical day will include:

Primary responsibilities of this position are to:

--- Provide professional expertise and strong leadership inapplicable guidance and regulations, proactivelyidentifyingpotential areas of non-compliance and risk for assignedareas.

--- Execute Internal Supplier Audit strategy at the direction ofthe Head of Internal & Supplier Audits

--- Serve as a QA & Compliance Liaison for Preferred ProvidersGovernance Councils or internal committees, as assigned

--- Provide Compliance & Management Support for identifiedissues arising with supported R&D Business areas, and for otherQA &Compliance project initiatives

--- Provide support for QA & Compliance Regulatory AgencyInspections

Responsibilities

Audit Coordination

Liaise and network with internal and external businesspartnersto implement ISA strategy

Lead the planning, execution and close out of assignedISAaudits

Lead ISA driven CAPAs, effectiveness checks, andissueescalation, as assigned

Designated auditor/co-auditor for assigned ISA audits

Lead ISA facilitated meetings.

Participate in QA&C project initiatives (SystemDevelopmentand COE driven)

QA&C Liaison for Preferred Provider(s)

Liaise and network with internal and external businesspartnersto provide guidance and support pertaining tocompliance/qualityoversight initiatives

Prepare and lead or support governance councilmeetings

Facilitate issue escalation and oversight of remediationasappropriate

Manage preferred provider partnership as assigned

Internal Supplier & Audits and QA & Compliance Support

Liaise and network with internal and external businesspartnersto implement ISA and QA&C initiatives

Lead and/or support the planning, execution and close outofassigned ISA and QA&C initiatives

Provide compliance guidance and support for R&Dasappropriate

Provide support to management as requested

Regulatory Agency Support

Support, as needed, the preparation,conductfollow-up/responding, and lessons learned to GXPinspections

Education and Experience Requirements

--- Bachelors degree in a life science or equivalent experience;Graduate degree in a scientific discipline or program managementaplus

--- Minimum of 8 years of pharmaceutical experience, includinginternational experience

--- Ideal candidate will have broad experience in productdevelopment, regulatory compliance, supplier management,GxPauditing and at least 3 years of direct or matrixmanagementexperience.

Key Skills, Abilities, and Competencies

--- Extensive knowledge and/or awareness of local andinternational regulations. Maintains awareness of newlypublishedregulations.

--- Strong understanding of the: drug development processes,clinical development operations, vendor outsourcing andprocurementprocesses, regulatory affairs, GXP and internalprocessauditing

--- Collaborative team player who has the ability to think andact quickly and identify creative solutions to complex problems

--- Robust technical writing skills. Ability to write briefingdocuments, quality positions, audit reports and SOPs.

--- Strong attention to detail with the ability to articulatequality related risks and potential impact.

--- Leadership skills, and ability to inspire colleagues

--- Ability to take a big-picture approach to decision-makingwhile taking account of the broad interests of Shire.

--- Strong project management and decision-making skills

--- A self-starter, who motivates, has tact and diplomacy and isable to define and prioritize tasks within a project

--- Excellent communication and interpersonal skills.

--- Demonstrates ability to manage global staff/activities

--- Ability to foster and balance a culture of compliance withina culture of innovation

--- Strategic thinking

--- Ability to influence without authority, in a matrixenvironment

--- Proficient knowledge of MS Word, Excel, PowerPoint &Outlook; working knowledge of Access, Trackwise a plus.

Complexity and Problem Solving

--- Exerts influence in the development of overall objectivesand long-range goals of the organization.

--- Acts as an advisor to meet schedules or resolve technical oroperational problems

--- Directly participates in establishing and administeringcentralized functional projects

--- Works on complex problems requiring analysis of situationsor data and in-depth analysis of factors

--- Exercises judgment within broadly defined practices andpolicies in selecting methods, techniques and evaluationcriteriafor obtaining results.

Internal and External Contacts

--- Interacts across R&D QA & Compliance and R&DBusiness Partners

Other Job Requirements

--- Domestic and international travel may be required perbusiness need.

--- Must have a global mindset.

WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual RetirementContributionPlan

Company match of charitable contributions

Health & Wellness programs including onsite flu shots andhealthscreenings

Generous time off for vacation and the option topurchaseadditional vacation days

Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-LR1LocationsCambridge, MAWorkerTypeEmployeeWorkerSub-TypeRegularTime TypeFull time

Keywords: Takeda, Cambridge , Associate Director, PartnershipQuality Lead, Executive , Cambridge, Massachusetts

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Keywords: Takeda Pharmaceuticals North America, Inc., Cambridge , Associate Director, Software Engineering, Other , Cambridge, Massachusetts

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