Assoc Director, R&D Quality
Assoc Director, R&D Quality
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$ 182070 - 235620
1 Vacancy
Job Description
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
Gilead R&D Quality 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 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
As the Associate Director R&D Quality you will be responsible for the following:
- Area of responsibility may be limited to Clinical Compliance Laboratory Compliance or Electronic Systems Compliance.
- Fosters a commitment to quality in individuals and a culture of quality within the organization.
- Work is performed with little to no immediate supervision. Evaluates new tools as fit for purpose.
- Coordinates and reviews the work of others.
- Manages and/or leads various types of audits or projects involving multiple sites or therapeutic areas.
- Directs others in the oversight of activities performed by contract auditors.
- Establishes relationships and agreements with contract auditors.
- Evaluates departmental and business area SOPs for fit for purpose and in compliance with regulatory requirements.
- Ensures adherence to departmental across sites.
- Leads intra- or interdepartmental teams of an operational nature such as: preparing the Company for minor changes in regulations continuous improvement initiatives.
- Purpose is for input and obtaining information for dissemination intra- or interdepartmentally.
- Assists in readiness for and regulatory agency inspections. Assists in the coordination of responses to any regulatory agency findings.
- Developing and presenting training using standard modules and training on special topics.
- Ensures appropriate content of training modules.
- Initiate operational change where required and communicate change in a positive manner.
- Considers a number of factors in planning anticipate work and prioritize work to meet tight timelines.
- Direct others in prioritizing their work.
- Define systems or processes to consistently ensure the high standards required in Compliance.
- Checks perspective of others and adapts communication approach accordingly.
- Builds positive support for position outside of formal meetings.
- Determines most efficient and appropriate method of communication in a variety of situations.
- Understands impact of decisions and actions on business and consults with appropriate colleagues and management as applicable.
- Promotes and maintains productive working relationships.
- Mentors others in establishing good working relationships.
- Addresses sensitive issues in an objective manner.
- Must have a thorough knowledge of regulatory requirements for assigned territories.
- Is recognized as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource.
- Understands current global and regional trends in regulatory compliance.
Basic Qualifications:
- 10 Years with BS/BA
- OR
- 8 Years with MS/MA or MBA
Preferred Qualifications:
- Experience leading GVP audits in the biopharma or related industry.
- Relevant work experience consists of working in a pharmaceutical quality control quality assurance or compliance environment.
- Strong critical and strategic thinking skill and risk-based mindset.
- Ability to travel minimum of 30%.
People leader accountabilities
- Create inclusion - knowing the business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.
- Develop talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow develop and realize their purpose.
- Empower teams - connect the team to the organization by aligning goals purpose and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
For additional benefits information visit:
For jobs in the United States:
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
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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
Employment Type
Full-Time
