Director, GCP Inspection Readiness & Management
Job Location:
Parsippany, NJ - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
AstheDirector GCP Inspection Readiness & Managementat Gilead you willmaintaina continuousenterprisewidestate of GCP inspection readiness across R&D clinical trials. TheDirector GCP Inspection Readiness & Managementserves as a lead sponsor representative and primarypointofcontactduring regulatory inspections and provides strategic leadership to evolve Gileads global inspection management capabilities.
This positionoperateswith significant autonomy and influence partneringcrossfunctionallyacross R&D Quality and external vendors to ensure inspection preparedness execution excellence and continuous improvement.
This position is based in Parsippany NJ.Relocation assistance is not available so local candidates are encouraged to apply.
Key Responsibilities & Outcomes
Enterprise GCP Inspection Leadership
LeadGCPinspectionreadinesspreparation conduct and closeout.
Coordinate unifiedtimely and compliant responses to inspector requests andfollowupactions.
Inspection Readiness Strategy & Governance
Develop andmaintainshortandlongrangeGCPinspection management strategies infrastructure and resource plans.
Establish standards and processes defininginspectionreadiness and integrate lessons learned into continuous readiness practices.
Conduct horizon scanning and integrate regulatory intelligence to proactively assess and mitigate inspection risks.
TMF/eTMF & Vendor Readiness Oversight
Own TMF/eTMF inspection readiness expectations and lead periodic health checks.
Leadriskbasedreadiness assessments and inspection drills for key clinical vendors (e.g. CROs labseCOA IRT).
PartnerwithR&D Quality stakeholdersto ensure sustained readiness.
Metrics Insights & Continuous Improvement
Definemaintain and analyze GCP inspection readiness KPIs (e.g. readiness scorecards TMF quality signals response timeliness CAPA cycle time).
Contributeinspectionmetrics and trend analysis into Quality Management Reviews.
Drive Veeva QMS record development for inspection findings action plans and commitmentfollowup.
Training Change Management &ProjectLeadership
Develop and deliverGCPinspectionspecifictraining playbooks and readiness frameworks.
Provide matrixed leadership to inspection teams and Subject Matter Experts.
Foster a culture of quality and inspection readiness across Gilead R&D and vendor partners.
Significant experienceadvisingbiopharma business functions on quality and compliance requirements evolving regulations risk minimization mitigation and continuous improvement.
Significant experiencein GCP inspection management in the biopharma industry including keyfrontroomand/orbackroominspection roles.
Demonstrated ability to managelargescale complex andtimesensitiveinitiatives.
Proven experience leadingcrossfunctionalprocess improvement initiatives with measurable outcomes.
Expert knowledge of GCP the drug development process and TMF/eTMF requirements.
Strong knowledge ofGxPQuality Management Systems policies and procedures.
Demonstrated leadership presence with the ability to influence without authority.
Strong analytical communication and organizational skills.
Ability to travel when.
BASIC QUALIFICATIONS
PharmD or PhD with 8 years of relevant experience; OR
MA/MS/MBA with 10 years of relevant experience; OR
BA/BS with 12 years of relevant experience.
PREFERRED QUALIFICATIONS
Experience working for or directly with a global health authority.
Experiencerepresentingorganizations in external consortiums trade associations or industry working groups.
Demonstrated success developing or scaling inspection management infrastructure in a global R&D environment.
Strong coaching and mentoring capabilities with experience developing quality or inspection leaders.
Experience contributing to resourcing and budget planning for quality or inspection management functions.
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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Director
About Company
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 ensu ... View more
