AGIOS PHARMACEUTICALS, INC.

Associate Director, Digital Quality and Data Integrity

A-22217-01285 H-1B 2023 Certified

Salary

$167,502

Visa Type

H-1B

Job Title

Associate Director, Digital Quality and Data Integrity

Employee's Citizenship

INDIA

Graduate School

UNIVERSITY OF FLORIDA

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22217-01285

Case Status Certified

Received Date 2022-08-12

Decision Date 2023-05-22

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name AGIOS PHARMACEUTICALS, INC.

Employer Address_Line 1 88 SIDNEY STREET

Employer Address_Line 2 -

Employer City CAMBRIDGE

State -

Employer State/ Province MASSACHUSETTS

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 2139

Employer Phone No. 6176498600

Employer Phone Extent No. -

Total Number of Employees 392

Employer Year of Commenced 2008

NAICS Code 325412

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Gabriela Smith

Employer Contact Address Line1 88 Sidney Street

Employer Contact Address Line2 -

Employer Contact City Cambridge

Employer Contact State/ Provice MASSACHUSETTS

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 2139

Employer Contact Phone 8572093398

Employer Contact Email gabriela.smith@agios.com

Attorney

11 fields

Agent/ Attorney Name Rebecca J Bernhard

Agent/ Attorney Firm Name Dorsey Whitney LLP

Agent/ Attorney Phone 6124926185

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 50 South Sixth Street

Agent/ Attorney Address Line 2 Suite 1500

Agent/ Attorney City Minneapolis

Agent/ Attorney State/ Province MINNESOTA

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code 55402

Agent/ Attorney Email mpls-iv@dorsey.com

Position Info

89 fields

Prevailing Wage Track Number P10021207482654

Prevailing Wage SOC Code 11-3021.00

Prevailing Wage SOC Title Computer and Information Systems Managers

Prevailing Wage Skill Level Level III

Prevailing Wage 167502

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-01-11

Prevailing Wage Expiration Date 2022-06-30

Wage Offer From 167502

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 88 Sidney Street

Worksite Address Line 2 -

Worksite City Cambridge

Worksite State MASSACHUSETTS

Worksite Postal Code 2139

Job Title Associate Director, Digital Quality and Data Integrity

Minimum Education Master's

Other Degree/ Diploma -

Major Field of Study Computer Science, Engineering, Chemistry, or closely related field

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

Accept Alternate Field of Study Y

Accept Alternate Major Computer Science, Engineering, Chemistry, or closely related field

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 36

Accept Alternate Job Title See H.14

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Position requires at least a Masters degree in Computer Science, Engineering, Chemistry, or closely related field. A qualified candidate must have at least 3 years 36 months of Quality AssuranceValidation Engineering experience in a GxP pharmaceutical environment. A qualified candidate must have at least 3 years 36 months of experience a working with quality systems and regulatory requirements, ensuring US FDA regulationsguidelinescompliance such as 21 CRF 11, 21 CRF 210, 21 CRF 211, 21 CRF 820, ISO 13485, ISO 14971, GAMP 5, ICH, SOX, EU Annex 11 testingcompliance are met, b ensuring compliance with Good Manufacturing Practice GMP and FDA regulations, c developing and reviewing Standard Operating Procedures SOPs for system use, d participating in the review and approval of GxP computer system related CAPAs and change controls, e generation of IQOQPQ protocols, and f implementing effective practices and ensuring quality throughout the validation lifecycle for systems. All experience may be gained concurrently. Employer will accept candidates with any suitable combination of education and experience as described in H4 to H10, above.

Combination Occupation N

Offered to Applied Foreign Worker Y

ForeignWorker Live on Premises N

Live in Domestic Service Worker N

Employment Contract -

Professional Occupation Y

College/ University Teacher N

Competitive Process -

Basic Recruitment Process -

Teacher Select Date -

Teacher Publish Journal Name -

Additional Recruitment Information -

Job Oder Start Date 2022-05-10

Job Oder End Date 2022-06-10

Sunday Edition Newspaper Y

First Newspaper Name Boston Globe

First Advertisement Start Date 2022-05-22

Second Newspaper Name Boston Globe

Second Advertisement Type Newspaper

Second Ad Start Date 2022-05-29

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2022-05-10

Employer Website to Date 2022-05-24

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-05-23

Job Search Website to Date 2022-05-30

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date -

Employee Referral Program to Date -

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-05-26

Local Ethnic Newspaper to Date 2022-05-26

Radio/TV Ad from Date -

Radio/TV Ad to Date -

Employer Received the Payment N

Payment Details -

Bargaining Representative Notified N/A

Posted Notice at Worksite Y

Layoff in Past Six Months N

US Worker Considered -

Country of Citizenship INDIA

Foreign Worker Birth Country INDIA

Class of Admission H-1B

Employee Info

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major CHEMICAL ENGINEERING

Year of Compelted Education 2011

Foreign Worker Istitution of Eduation UNIVERSITY OF FLORIDA

Foreign Worker Education Instution Address Line 1 222 CRISER HALL

Foreign Worker Education Institution Address Line 2 BOX 114000

Foreign Worker Education Institution City GAINESVILLE

Foreign Worker Educatution Institution State FL

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 32611

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N/A

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name Rebecca Bernhard

Preparer Title Attorney

Preparer Email mpls-iv@dorsey.com

Employer Information Declaration Name Gaby Smith

Employer Declaration Title Sr. HR Specialist