interview process may be conducted virtually and some roles will be
asked to temporarily work from home. Over the coming weeks and months,
we will be implementing a phased approach to bringing employees back
to site to ensure the health and safety of our teams.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Job Description
Would you like to play a crucial role in developing life-saving
therapies? Are you excited to use your scientific insight to partner
with internal teams, and external partners as we strive to cure unmet
medical needs?
We are looking for a Quality and Compliance Sr. Manager who is ready
to dive-in to support our clinical development and post-marketing
safety programs. As a Quality and Compliance Sr. Manager, you will
support global GCP & GVP compliance activities that include the
Internal Process and Vendor Audit Programs and Inspection Management
activities. You will work closely with internal functional
stakeholders, study management teams and external stakeholders.
This role is suited to candidates who possess a strong proactive
quality mindset, strategic thinking ability and project management
skills. Utilizing expert GCP/PV knowledge, you will be a trusted
business partner effectively communicating and collaborating with
internal and external stakeholders and the R&D Quality and
Compliance Management Team.
You will be a part of an expert and supportive team that fosters
constructive collaboration in support of our clinical development and
post marketing programs.
Primary Responsibilities
*
Support execution of the global activities for Gilead?s global
GCP/GVP Internal Process and Vendor Audit Programs.
*
Perform risk assessment and develop audit strategy for assigned areas
*
Support and/or lead GVP routine and complex audits for Gilead
Affiliate offices, distributors, external partners, and vendors
*
Support and/or lead GCP Internal Process audits.
*
Support and/or lead GCP Vendor Audits
*
Liaises with internal Gilead business functions in compliance
activities
*
Support/lead inspection readiness preparation, and/or directly support
regulatory agency inspection as needed.
*
Support review of operating procedures (e.g. SOPs) and perform other
activities in support of an integrated cross-functional quality
management system (QMS).
*
Effective compliance reporting to senior management and relevant
quality governance forums.
*
Report and investigate compliance issues
*
Support CAPA development and perform effectiveness checks of CAPAs
*
Represent Quality & Compliance in cross functional working groups &
initiatives
*
Fosters a commitment to quality in individuals and a culture of
quality within the organization.
*
Provides expert, timely and risk-based guidance in line with
regulations & business needs
*
Direct contract auditors and others who oversee activities performed
by contract auditors.
Sr. Manager: Qualifications
*
BA or BS and 8+ years of relevant experience (6+ years of relevant
experience with an MS).
*
GCP audit and compliance experience required.
*
Bio-pharma sponsor experience required.
*
PV audit experience strongly preferred.
*
Inspection management experience preferred.
*
Strong verbal and written communication skills and interpersonal
skills.
*
Experience with audit management/CAPA management programs strongly
preferred.
*
Excellent organization skills and project management.
*
Able to work equally well as part of a team or independently
About Gilead R&D Quality and Compliance
Gilead R&D Quality and Compliance is a phenomenal place to develop
your skills and expertise. Our strong pipeline of therapies will
provide you opportunities to be challenged and stretched while
supported and developed by our diverse and expert team.
We are a committed team of highly skilled Quality and Compliance
professionals dedicated to helping deliver life-saving therapies for
unmet needs. We bring our passion for science, discovery, and creative
thinking into everything we do.
We are an inclusive and diverse community, who are supported by strong
leaders that are committed to giving each of us a voice while
achieving our mission. Our collaborative and supportive structure will
help you develop your skills, experience, and your career.
Are you ready to explore how you can play a vital role on the team and
help deliver life-saving therapies to patients around the world?
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and
affiliates (collectively "Gilead" or the "Company") to recruit select
and employ the most qualified persons available for positions
throughout the Company. ?Except if otherwise provided by applicable
law, all ?employment actions relating to issues such as compensation,
benefits, transfers, layoffs, returns from layoffs, company-sponsored
training, education assistance, social and recreational programs are
administered on a non-discriminatory basis (i.e. without regard to
protected characteristics or prohibited grounds, which may include an
individual?s gender, race, color, national origin, ancestry,
religion, creed, physical or mental disability, marital status, sexual
orientation, medical condition, veteran status, and age, unless such
protection is prohibited by federal, state, municipal, provincial,
local or other applicable laws). ?Gilead also prohibits
discrimination based on any other characteristics protected by
applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
_THIS EMPLOYER IS A CORPORATE MEMBER OF MYGWORK, THE BUSINESS
COMMUNITY FOR LGBTQ+ PROFESSIONALS, GRADUATES, INCLUSIVE EMPLOYERS &
ANYONE WHO BELIEVES IN WORKPLACE EQUALITY._
Gilead Sciences is continuing to hire for all open roles. Our
interview process may be conducted virtually and some roles will be
asked to temporarily work from home. Over the coming weeks and months,
we will be implementing a phased approach to bringing employees back
to site to ensure the health and safety of our teams.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Job Description
Would you like to play a crucial role in developing life-saving
therapies? Are you excited to use your scientific insight to partner
with internal teams, and external partners as we strive to cure unmet
medical needs?
We are looking for a Quality and Compliance Sr. Manager who is ready
to dive-in to support our clinical development and post-marketing
safety programs. As a Quality and Compliance Sr. Manager, you will
support global GCP & GVP compliance activities that include the
Internal Process and Vendor Audit Programs and Inspection Management
activities. You will work closely with internal functional
stakeholders, study management teams and external stakeholders.
This role is suited to candidates who possess a strong proactive
quality mindset, strategic thinking ability and project management
skills. Utilizing expert GCP/PV knowledge, you will be a trusted
business partner effectively communicating and collaborating with
internal and external stakeholders and the R&D Quality and
Compliance Management Team.
You will be a part of an expert and supportive team that fosters
constructive collaboration in support of our clinical development and
post marketing programs.
Primary Responsibilities
*
Support execution of the global activities for Gilead?s global
GCP/GVP Internal Process and Vendor Audit Programs.
*
Perform risk assessment and develop audit strategy for assigned areas
*
Support and/or lead GVP routine and complex audits for Gilead
Affiliate offices, distributors, external partners, and vendors
*
Support and/or lead GCP Internal Process audits.
*
Support and/or lead GCP Vendor Audits
*
Liaises with internal Gilead business functions in compliance
activities
*
Support/lead inspection readiness preparation, and/or directly support
regulatory agency inspection as needed.
*
Support review of operating procedures (e.g. SOPs) and perform other
activities in support of an integrated cross-functional quality
management system (QMS).
*
Effective compliance reporting to senior management and relevant
quality governance forums.
*
Report and investigate compliance issues
*
Support CAPA development and perform effectiveness checks of CAPAs
*
Represent Quality & Compliance in cross functional working groups &
initiatives
*
Fosters a commitment to quality in individuals and a culture of
quality within the organization.
*
Provides expert, timely and risk-based guidance in line with
regulations & business needs
*
Direct contract auditors and others who oversee activities performed
by contract auditors.
Sr. Manager: Qualifications
*
BA or BS and 8+ years of relevant experience (6+ years of relevant
experience with an MS).
*
GCP audit and compliance experience required.
*
Bio-pharma sponsor experience required.
*
PV audit experience strongly preferred.
*
Inspection management experience preferred.
*
Strong verbal and written communication skills and interpersonal
skills.
*
Experience with audit management/CAPA management programs strongly
preferred.
*
Excellent organization skills and project management.
*
Able to work equally well as part of a team or independently
About Gilead R&D Quality and Compliance
Gilead R&D Quality and Compliance is a phenomenal place to develop
your skills and expertise. Our strong pipeline of therapies will
provide you opportunities to be challenged and stretched while
supported and developed by our diverse and expert team.
We are a committed team of highly skilled Quality and Compliance
professionals dedicated to helping deliver life-saving therapies for
unmet needs. We bring our passion for science, discovery, and creative
thinking into everything we do.
We are an inclusive and diverse community, who are supported by strong
leaders that are committed to giving each of us a voice while
achieving our mission. Our collaborative and supportive structure will
help you develop your skills, experience, and your career.
Are you ready to explore how you can play a vital role on the team and
help deliver life-saving therapies to patients around the world?
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and
affiliates (collectively "Gilead" or the "Company") to recruit select
and employ the most qualified persons available for positions
throughout the Company. ?Except if otherwise provided by applicable
law, all ?employment actions relating to issues such as compensation,
benefits, transfers, layoffs, returns from layoffs, company-sponsored
training, education assistance, social and recreational programs are
administered on a non-discriminatory basis (i.e. without regard to
protected characteristics or prohibited grounds, which may include an
individual?s gender, race, color, national origin, ancestry,
religion, creed, physical or mental disability, marital status, sexual
orientation, medical condition, veteran status, and age, unless such
protection is prohibited by federal, state, municipal, provincial,
local or other applicable laws). ?Gilead also prohibits
discrimination based on any other characteristics protected by
applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
_THIS EMPLOYER IS A CORPORATE MEMBER OF MYGWORK, THE BUSINESS
COMMUNITY FOR LGBTQ+ PROFESSIONALS, GRADUATES, INCLUSIVE EMPLOYERS &
ANYONE WHO BELIEVES IN WORKPLACE EQUALITY._
We need : English (Good)
Type: Permanent
Payment:
Category: Others
