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Manager, QA Compliance - Global Quality Agreements - III

Job Description

My name is Rohit  I’m a Recruiter with ACS Group, a leading information technology services and workforce solutions company, and I’m contacting you about an opportunity with one of our clients. ACS works closely with Fortune 1000 firms throughout the US and provides top talent for various staffing needs across industries.



Please review the Job Description provided below and if interested, please call me at 770-255-7921 OR reply to this email



Kindly send your current and updated CV in MS Word Format for evaluation, scrutiny, assessment and possible consideration


 


Below are the Details of Opportunity


-----------------------------------------------------


Position:-  :     Manager, QA Compliance - Global Quality Agreements - III


Location:-  Foster City, California 


Duration:-  +12 Months



Job Requirements

The Manager, QA Compliance will report to the Associate Director, QA Compliance - Global Quality Agreements within the Supplier Management and Audits department. This is a newly created position dedicated to support of the establishment, implementation and maintenance of the companys Global Quality Agreement Program initiatives. This position will have high visibility and will collaborate with essential key internal partners/stakeholders to ascertain Quality/business requirements to establish effective and timely Quality Agreements with various types of GMP suppliers/service providers, customers and strategic alliance/marketing partners.



Responsible for assisting with the implementation of the Global Quality Agreement Program initiatives (governance, oversight, processes and services) by collaborating cross-functionally and geographically with key stakeholders


Responsible for managing the Quality (Technical) Agreement (QAG) life-cycle process (processing requests, reviewing, drafting, negotiating, routing for approvals/signatures, archiving, amending/revising, conducting periodic reviews, and retiring) for Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), GMP Materials Suppliers, GMP Services Providers, as well as Marketing/Strategic Alliance Partners and Intra-Company GMP activities, in accordance with applicable GMP regulations and Gilead policies, procedures and practices. Perform risk assessment of proposed terms/quality provisions in QAGs and develop recommendations to minimize their potential risk to the business


Co-develop negotiation strategies with and ensure the completion of applicable reviews of QAGs by key stakeholders (Quality (Clinical/Commercial) personnel, Production/Operations, Outsourcing Management, Supply Chain Management, Business Operations Contract Compliance (BOCC), Alliance Management, Legal/Contracts and/or other applicable Subject Matter Experts), obtaining leadership approvals, as required, to ensure companys position is operationally correct and accurately reflected in the QAG. Ensures the QAG is in alignment and not conflicting with the primary, business agreement


Coordinates meetings with external parties (CMOs, CTLs, GMP Material Suppliers, GMP Services Providers) and internal stakeholders/SMEs and facilitates the review and negotiation of QAGs


Coordinate systems and procedures related to processing of QAGs; prepares/assembles the final QAG package for authorized approval signatures and publishing in global electronic QAG life-cycle management system / repository


Assists with the administration and maintenance of the Global QAG database/tracker to reflect real time data/status; assists with the generation and preparation of QAG/Program metrics / status reports and presentations to Senior Leadership


Responds to requests and inquiries related to QAGs (content/statuses, etc.) from internal stakeholders


Assist in the development and implementation of policies, standards, SOPs, work instruction/job aids for the management of QAGs and compliance monitoring thereof


Creates training materials and conducts training related to QAGs ,the Global QAG Program and its systems and tools


Collaborates with key stakeholders to develop standardized, fit-for-purpose QAG Templates; Manages the review, approval, issuance, revision and retirement of QAG Templates


Provides global QAG Program systems and processes support to SMA/QAG team and participates in system and process improvements and remediation (perform gap assessments and participate in development and execution of remediation strategies


Other duties as required or assigned by Manager to meet business needs


Essential Functions:



Assigns, monitors and reviews progress and accuracy of work for an individual, a group of employees, or a project.



Follows up on questions from assigned departments.



Leads by example to foster a commitment to quality in personnel, and a culture of quality within the organization.



Assists with maintaining standard of quality for compliance department operations.



Assists in regulatory agency inspections.



Interacts and influences peers to ensure successful project completion.



Maintains current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility.



Provides guidance on interpretation and application of specified QA compliance regulations.



Assists in the evaluation and implementation of standard operating procedures and systems needed to comply with requirements. Knowledge, Experience & Skills: Essential:



Demonstrates excellent organization skills and ability to work on a number of projects to tight timelines.


Demonstrates excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance.


Demonstrates excellent verbal, written, and interpersonal skills.


Capable of taking a leadership role in updating and preparing the company for minor changes in regulations.


Specific Education & Experience Requirements: 8+ years of relevant experience in the pharmaceutical industry and a BS or BA. 6+ years of relevant experience and a MS



Desirable:



Demonstrates expertise with quality agreements for both domestic and international GMP regulations and/or extensive contracting (contract drafting/negotiating) experience in the pharmaceutical/biopharmaceutical industry


Demonstrates excellent influencing, negotiation, and technical / business writing skills


Excellent project management skills / experience


Demonstrates the ability to incorporate sound Risk Management fundamentals in the establishment of quality agreement content


Demonstrates excellent technical/business/legal writing skills; must have strong document or contract management skills (word processing/formatting)


Excellent working knowledge of computer systems/applications; i.e. Microsoft Word, Excel, Pivot tables, Visio, Gantt Charts, and PowerPoint


In-depth experience with electronic document control management or electronic contract life-cycle management systems (e.g.: Documentum, Veeva Quality Docs, Apttus, Ariba, or other electronic document control/contract life-cycle management systems)


Strategic and technical knowledge for managing global quality agreement processes for various types of service providers


Supplier management or audit management experience

Job Snapshot

Location US-CA-Foster City
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type
Apply

Company Overview

American Cybersystems, Inc. (ACS Group)

ACS Group provides services to Fortune 1000 companies across various industry verticals. With a proven track record of managing project demands while improving the efficiency, productivity and profitability of new and existing projects through process improvement, ACS Group is consistently recognized for identifying and implementing strategic solutions that create and preserve long-term business value. Learn More

Contact Information

US-CA-Foster City
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Snapshot
American Cybersystems, Inc. (ACS Group)
Company:
US-CA-Foster City
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Store Type:

Job Description

My name is Rohit  I’m a Recruiter with ACS Group, a leading information technology services and workforce solutions company, and I’m contacting you about an opportunity with one of our clients. ACS works closely with Fortune 1000 firms throughout the US and provides top talent for various staffing needs across industries.



Please review the Job Description provided below and if interested, please call me at 770-255-7921 OR reply to this email



Kindly send your current and updated CV in MS Word Format for evaluation, scrutiny, assessment and possible consideration


 


Below are the Details of Opportunity


-----------------------------------------------------


Position:-  :     Manager, QA Compliance - Global Quality Agreements - III


Location:-  Foster City, California 


Duration:-  +12 Months



Job Requirements

The Manager, QA Compliance will report to the Associate Director, QA Compliance - Global Quality Agreements within the Supplier Management and Audits department. This is a newly created position dedicated to support of the establishment, implementation and maintenance of the companys Global Quality Agreement Program initiatives. This position will have high visibility and will collaborate with essential key internal partners/stakeholders to ascertain Quality/business requirements to establish effective and timely Quality Agreements with various types of GMP suppliers/service providers, customers and strategic alliance/marketing partners.



Responsible for assisting with the implementation of the Global Quality Agreement Program initiatives (governance, oversight, processes and services) by collaborating cross-functionally and geographically with key stakeholders


Responsible for managing the Quality (Technical) Agreement (QAG) life-cycle process (processing requests, reviewing, drafting, negotiating, routing for approvals/signatures, archiving, amending/revising, conducting periodic reviews, and retiring) for Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), GMP Materials Suppliers, GMP Services Providers, as well as Marketing/Strategic Alliance Partners and Intra-Company GMP activities, in accordance with applicable GMP regulations and Gilead policies, procedures and practices. Perform risk assessment of proposed terms/quality provisions in QAGs and develop recommendations to minimize their potential risk to the business


Co-develop negotiation strategies with and ensure the completion of applicable reviews of QAGs by key stakeholders (Quality (Clinical/Commercial) personnel, Production/Operations, Outsourcing Management, Supply Chain Management, Business Operations Contract Compliance (BOCC), Alliance Management, Legal/Contracts and/or other applicable Subject Matter Experts), obtaining leadership approvals, as required, to ensure companys position is operationally correct and accurately reflected in the QAG. Ensures the QAG is in alignment and not conflicting with the primary, business agreement


Coordinates meetings with external parties (CMOs, CTLs, GMP Material Suppliers, GMP Services Providers) and internal stakeholders/SMEs and facilitates the review and negotiation of QAGs


Coordinate systems and procedures related to processing of QAGs; prepares/assembles the final QAG package for authorized approval signatures and publishing in global electronic QAG life-cycle management system / repository


Assists with the administration and maintenance of the Global QAG database/tracker to reflect real time data/status; assists with the generation and preparation of QAG/Program metrics / status reports and presentations to Senior Leadership


Responds to requests and inquiries related to QAGs (content/statuses, etc.) from internal stakeholders


Assist in the development and implementation of policies, standards, SOPs, work instruction/job aids for the management of QAGs and compliance monitoring thereof


Creates training materials and conducts training related to QAGs ,the Global QAG Program and its systems and tools


Collaborates with key stakeholders to develop standardized, fit-for-purpose QAG Templates; Manages the review, approval, issuance, revision and retirement of QAG Templates


Provides global QAG Program systems and processes support to SMA/QAG team and participates in system and process improvements and remediation (perform gap assessments and participate in development and execution of remediation strategies


Other duties as required or assigned by Manager to meet business needs


Essential Functions:



Assigns, monitors and reviews progress and accuracy of work for an individual, a group of employees, or a project.



Follows up on questions from assigned departments.



Leads by example to foster a commitment to quality in personnel, and a culture of quality within the organization.



Assists with maintaining standard of quality for compliance department operations.



Assists in regulatory agency inspections.



Interacts and influences peers to ensure successful project completion.



Maintains current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility.



Provides guidance on interpretation and application of specified QA compliance regulations.



Assists in the evaluation and implementation of standard operating procedures and systems needed to comply with requirements. Knowledge, Experience & Skills: Essential:



Demonstrates excellent organization skills and ability to work on a number of projects to tight timelines.


Demonstrates excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance.


Demonstrates excellent verbal, written, and interpersonal skills.


Capable of taking a leadership role in updating and preparing the company for minor changes in regulations.


Specific Education & Experience Requirements: 8+ years of relevant experience in the pharmaceutical industry and a BS or BA. 6+ years of relevant experience and a MS



Desirable:



Demonstrates expertise with quality agreements for both domestic and international GMP regulations and/or extensive contracting (contract drafting/negotiating) experience in the pharmaceutical/biopharmaceutical industry


Demonstrates excellent influencing, negotiation, and technical / business writing skills


Excellent project management skills / experience


Demonstrates the ability to incorporate sound Risk Management fundamentals in the establishment of quality agreement content


Demonstrates excellent technical/business/legal writing skills; must have strong document or contract management skills (word processing/formatting)


Excellent working knowledge of computer systems/applications; i.e. Microsoft Word, Excel, Pivot tables, Visio, Gantt Charts, and PowerPoint


In-depth experience with electronic document control management or electronic contract life-cycle management systems (e.g.: Documentum, Veeva Quality Docs, Apttus, Ariba, or other electronic document control/contract life-cycle management systems)


Strategic and technical knowledge for managing global quality agreement processes for various types of service providers


Supplier management or audit management experience

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