Associate / Director, Quality Systems and Compliance

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

Job Description:

Associate / Director, Quality Systems and Compliance Company: HCPro, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Associate / Director, Quality Systems and Compliance

Associate / Director, Quality Systems and ComplianceDescription

The Role:

Reporting to the Head Quality, International Organization, theAD/D of Quality Systems and Compliance will be responsible forimplementing world class quality system processes and operations toensure Moderna exceeds the highest level of compliance whilemonitoring the health of the Quality Management System (QMS) forcontinuous improvement in support of the internationalorganization. This leadership role located in Basel, Switzerlandwill assist in building a culture of quality at the site andprovide strong leadership and strategic direction of Moderna s QMSto support contract testing and manufacturing facilities andoverall international operations for Moderna clinical andcommercial products. The AD/D of Quality Systems and Compliancewill oversee supplier quality audits, third party and healthauthority inspections, internal audit program, document control,records management and training for the international organization.The incumbent will be an integral partner to Moderna s innovativetechnology platform as we continue to integrate automation anddigital technology into everything we do.

Here s What You ll Do:

Implement Moderna s overall Quality Management System (QMS) andquality manual, policies and procedures for the internationalorganization and ensure continuous improvement while keeping itcurrent with emerging and changing international regulations,guidance documents and current industry best practices andexpectations.

Provide cross functional quality leadership and act as a GXPcompliance subject matter expert on technical matters involvingproduct examination, testing and disposition, qualityinvestigations, validation, data integrity, and in business mattersinvolving facility and laboratory operations.

Work collaboratively with the digital team on the GXP integrateddigital landscape to support all e-systems, the utilization of datato accelerate and inform process and system performance and valuestream roadmaps for long range planning.

Evaluate business goals, identify improvement opportunities andapply scientific methods, statistics and problem-solving techniquesto improve and sustain product quality and process effectiveness inthe overall QMS lifecycle.

Oversee the performance of Moderna s QMS by leading Managementreview meetings and monitor the state of control and overallquality of Moderna s drug substances and drug products.

Manage the performance and effectiveness of the quality systemprograms such as risk management, change management, discrepancyand CAPA management, training, documentation and recordsmanagement, and data integrity.

Manage the internal audit and supplier audit programs and thirdparty/regulatory inspection programs for the internationalorganization.

This role requires approximately 40% international travel.

Here s What You ll Bring to the Table:

Bachelor degree, preferably in Sciences or Engineering withapplied Quality industry experience of 10-15 years.

Working knowledge of relevant EU and global regulations and ICH,ISPE, ASTM standards/guidelines and experience in hosting andfacilitating successful regulatory inspections.

Experience in computerized systems, automation, operations andmanufacturing and testing within biotechnology industry.

A proven track record of success in implementing and maintainingquality systems and e-systems in a biopharma organization.

Excellent interpersonal skills using a team-oriented approach toproject management and problem solving for complex issue resolutionin a scientifically sound and understandable way.

Outstanding communication skills (verbal and written) to allemployee levels, executive leadership and external partners,suppliers, third parties, and industry organizations.

Ability to conceptualize, analyze, plan and manage multipleprojects in a fast-paced environment.

Ability to be agile and effectively collaborate in a dynamic,cross-functional matrix environment.

A leader who is self-reflective and leads by example and drivesthe organization s performance with an attitude of continuousimprovement by being open to feedback and self-improvement.

Ability to navigate through ambiguity and rapid growth and adaptto change.

Track record of leading, coaching, and mentoringhigh-functioning and collaborative teams.

A digital first and curious mindset that allows you toconstantly learn and challenge the status quo.

About Moderna :

Moderna is advancing messenger RNA (mRNA) science to create anew class of transformative medicines for patients. mRNA medicinesare designed to direct the body s cells to produce intracellular,membrane or secreted proteins that can have a therapeutic orpreventive benefit and have the potential to address a broadspectrum of diseases. The Company s platform builds on continuousadvances in basic and applied mRNA science, delivery technology andmanufacturing, providing Moderna the capability to pursue inparallel a robust pipeline of new development candidates. Modernais developing therapeutics and vaccines for infectious diseases,immuno-oncology, rare diseases, cardiovascular diseases, andautoimmune and inflammatory diseases, independently and withstrategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently hasstrategic alliances for development programs with AstraZeneca, Plc.and Merck, Inc., as well as the Defense Advanced Research ProjectsAgency (DARPA), an agency of the U.S. Department of Defense, theBiomedical Advanced Research and Development Authority (BARDA), adivision of the Office of the Assistant Secretary for Preparednessand Response (ASPR) within the U.S. Department of Health and HumanServices (HHS) and the Coalition for Epidemic PreparednessInnovations (CEPI). Moderna has been ranked in the top ten ofScience s list of top biopharma industry employers for the pastfive years. To learn more, visit www.modernatx.com .

Our Mission:

Deliver on the promise of mRNA science to create a newgeneration of transformative medicines for patients.

Moderna is a smoke-free, alcohol-free and drug-free workenvironment.

#LI-AE1R2705

Job Information

Job ID: 54331855

Location:

Basel, United States

Position Title: Associate / Director, Quality Systems andCompliance

Company Name: Moderna Therapeutics

Job Function: Informatics,

IS/IT,

Quality Assurance

Please refer to the company's website or job descriptions tolearn more about them.

Sr. /Research Associate, Process Development

Norwood, United States

Cambridge, United States

Director, Clinical Development, Infectious Diseases (MD)

100 Winners Circle, Suite 300 Brentwood, Tennessee 37027 (978)624-4594

Keywords: HCPro, Inc., Cambridge , Associate / Director, Quality Systems and Compliance, Other , Cambridge, Massachusetts

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

Amazon Workforce Staffing: Warehouse Team Member

Description: Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation Fall River, MAJob opportunities vary by location. We update postings

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

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

Description: Seasonal Full-time

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Seasonal Full-Time Seasonal Warehouse Operator - $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 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 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

Amazon Workforce Staffing: Seasonal Part-Time Amazon Warehouse Operator - $1000 Sign-On Bonus

Description: Seasonal Part-time

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Order Picker/Packer - Immediate Hire (Fall River)

Description: Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation Fall River, MAJob opportunities vary by location. We update postings

Company: Amazon Workforce Staffing

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, Quality Systems and Compliance, Other , Cambridge, Massachusetts