CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Associate Director of Quality Operations

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

Job Description:

Associate Director of Quality Operations Company: Spectum Pharmaceuticals Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Associate Director of Quality Operations

Tracking Code 675-470 Job Description Summary:

The Associate Director of Quality Operations is responsible forproviding quality oversight to all manufacturing operations insupport of clinical development and commercial products, includingbut not limited to, Drug substance, Process Intermediates, and DrugProduct(s). This role requires extensive interaction with ClinicalOperations, Pharmaceutical Operations, Program and CMC projectmanagement, Regulatory Affairs, Supply Chain, and CMOs.

Responsibilities:

Provide quality oversight to all manufacturing operations insupport of clinical development and commercial products. Ensure allmanufacturing activities in support of Drug substance, ProcessIntermediates, and Drug Product(s), are conducted in accordancewith internal company standards and in compliance with qualityagreements.

Administering policies and standard operating procedures (SOPs)relating to the Quality Operations function. Identifyingopportunities for improvements.

Real time batch record review and resolution of associateddeviations prior to product disposition.

Quality oversight of Deviations and Change Controls at the CMOsites.

Developing and implementing appropriate quality training for theteam.

Provide all required documentation and support for the AnnualProduct Reviews

Review of CMC sections for regulatory submissions to ensureaccuracy and completeness. Participate in activities to assist withregulatory submissions, control strategy development and CMCstrategy.

Quality review and approval of Technology transfer protocols andfinal reports.

Preparation for regulatory inspections at the CMO sites.

Define, develop and implement short-term and long-termstrategies, goals, objectives and tactics relating to the QualityOperations function and the quality management system

Review and recommend appropriate corrective action to ensureconsistency with the Quality Operations function and the qualitymanagement system

Represent Quality Operations function and related processes inconnection with internal or external audits, inspections, andassist with quality-related information related to (but not limitedto) client assessments, RFPs, contracts and other documentation

Maintain current knowledge base of regulations, corporatepolicies and standards to ensure that the Quality Operationsfunction remain in compliance with applicable regulatory andcorporate standards/requirements and current with industry trendsand best practices

Identify risks and assumptions in plans, anticipate problems andplan for contingencies. Remove obstacles to move work forwardand/or to get efforts back on track.

Skills, Education and Experience:

Bachelor's Degree is required (Biological sciences, Engineeringor related degree); advanced degree is a plus

Minimum of 8 years related experience in thePharmaceutical/Biopharmaceutical/Biotechnology industry.

Ideally a minimum of 5 years of experience in leading a Qualityfunction, preferably at the senior manager level.

Proven ability to effectively develop, communicate, and gainsupport for execution plans with team members from otherfunctions.

Leadership and management skills to grow and manage a highperforming Quality organization.

Demonstrated skills in project management and working withvendors and contractors

Strong background in FDA, ISO, EMA, GMP and ICH requirementsideally for ATMPs.

Familiar with regulatory submissions, ideally for products whichwere ultimately approved for commercial distribution, andregulatory inspections.

Excellent judgment and creative problem-solving skills,including negotiation and conflict resolution skills, excellentinterpersonal skills, organizational skills, written and oralcommunication skills

Ability to work in a fast paced and dynamic environment thatwill require management of several competing priorities whiledriving all projects forward and meeting program/projectdeliverables

Energetic, flexible, collaborative and proactive; a leader whocan positively and productively impact initiatives.

Availability:

Must be available to work in the evenings and weekends, asrequired.

Position Location and/or Territory and Travel

Position is located in Irvine, CA or Cambridge, MA

Position may require up to 30 % travel and occasional localtravel

Spectrum Pharmaceuticals is an equal opportunity employer. Weevaluate qualified applicants without regard to race, color.Religion, sex, national origin, disability, veteran status, andother protected characteristics.

Job Location Cambridge, MA, United States Position TypeFull-Time/Regular

Keywords: Spectum Pharmaceuticals Inc., Cambridge , Associate Director of Quality Operations, Other , Cambridge, Massachusetts

Didn't find what you're looking for? Search again! Other Other Jobs

Amazon Workforce Staffing: Warehouse Team Member - Overnight Shifts Available

Description: Seasonal Part-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25/hr or more, plus benefits and a 1000 bonus Limited Time OpportunityLocation:Milford, MAJob opportunities vary (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Full-Time Amazon Package Sorter With Sign-On Bonus

Description: Seasonal Full-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25/hr or more, plus benefits and a 1,000 sign-on bonus. Limited Time OpportunityLocation:Milford, MAJob opportunities (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Finance Director - PBM

Description: FEI Career Center is part of the FEI Affinity Programs Solutions Portfolio, a collection of essential business solutions for finance professionals. Learn more about FEI Affinity Programs Solutions. (more...)

Company: CVS Caremark

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Seasonal Reduced-Time Amazon Warehouse Worker With Bonus Potential And Be

Description: Seasonal Part-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25/hr or more, plus benefits and a 1000 bonus Limited Time OpportunityLocation:Milford, MAJob opportunities vary (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Full-Time Amazon Package Sorter With Sign-On Bonus

Description: Seasonal Full-time

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Principal Consultant - US

Description: Infosys is seeking a skilled Business Process Consultant who will be accountable for the technical quality of the solution oversees development and support efforts. This position will be responsible (more...)

Company: infosys

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Seasonal Full-Time Warehouse Team Member - $1000 Sign-On Bonus

Description: Seasonal Full-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25/hr or more, plus benefits and a 1,000 sign-on bonus. Limited Time OpportunityLocation:Milford, MAJob opportunities (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Amazon Warehouse Assistant (Full-Time) - Day and Night Shifts Available - Up to$1000 sign on Bonus +

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Seasonal Full-Time Warehouse Worker - $1000 Sign-On Bonus

Description: Seasonal Full-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25/hr or more, plus benefits and a 1,000 sign-on bonus. Limited Time OpportunityLocation:Milford, MAJob opportunities (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Warehouser - Earn $15.25/hr or more, plus benefits and a $1,000 sign-on bonus

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

Company or Job Title Location (City, State) Powered by Company reviews , salary info, and interview questions for thousands of jobs .

Keywords: Amazon Workforce Staffing, Cambridge , Associate Director of Quality Operations, Other , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Principal Electrical Engineer
Description: Company: Raytheon Intelligence amp Space Location: Burlington Posted on: September 12, 2020 Job Description: Are you ready safer world What does it take to make the world a safer place It takes (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Principal Scientist
Description: Company: Sanofi Inc. Location: Cambridge Posted on: September 12, 2020 Job Description: At Sanofi, a global health care and pharmaceutical company,modeling and simulation approaches support strategy (more...)
Company: Sanofi Inc.
Location: Woonsocket
Posted on: 09/21/2020

Senior Manager, Application Development - Health Services
Description: Senior Manager, Application Development - Health Services Company: CVS Health Location: Woonsocket Posted on: September 16, 2020 Job Description: Senior Manager, Application Development - Health (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020


Marketing Safety Study Lead
Description: Company: Takeda Pharmaceuticals International GmbH Location: Cambridge Posted on: September 12, 2020 Job Description: The health and safety of our employees and candidates is veryimportant to us. (more...)
Company: Takeda Pharmaceuticals International GmbH
Location: Woonsocket
Posted on: 09/21/2020

Principal Scientist
Description: Senior Manager/Associate Director, Marketing - Rare Disease Company: UCB S.A. Location: Cambridge Posted on: September 16, 2020 Job Description: Keywords: UCB S.A., Cambridge , Senior Manager/Associate (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Senior Manager, Application Development - Health Services
Description: Company: Five Star Senior Living Location: Newton Posted on: September 13, 2020 Job Description: National Director of Dietary Services At Five Star Senior LivingApply Now Location Information Five (more...)
Company: Five Star Senior Living
Location: Woonsocket
Posted on: 09/21/2020

Principal Scientist
Description: Company: Spectraforce Technologies Inc Location: Cambridge Posted on: September 16, 2020 Job Description: Job Description What we do SPECTRAFORCE is an award winning global staffing, IT servicesand (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Principal Research Associate/Scientist
Description: Company: Lever Location: Cambridge Posted on: September 16, 2020 Job Description: Why Join Us Be a hero for our rare disease patients Ultragenyxis a commercial-stage biopharmaceutical company (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Director of Real Estate - Leasing & Surplus Property
Description: Director of Real Estate - Leasing amp Surplus Property Company: Burlington Stores Location: Burlington Posted on: September 12, 2020 Job Description: Search for City, State, Country, Zip Code (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Warehouse Team Member Full-Time with $500 Sign-on Bonus! - up to $18.25/hr
Description: Seasonal Part-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 500 bonus Limited-Time Opportunity Location: Milford, MA Job opportunities (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds