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Associate Director, External QA Biologics Development Lead

Employer
Gilead Sciences, Inc.
Location
Morris Plains, NJ
Start date
Nov 30, 2022

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Discipline
Quality, Quality Assurance, Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

Associate Director, External QA Biologics Development Lead
United States - New Jersey - Morris PlainsUnited States - California - OceansideUnited States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description


Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Associate Director, Ext QA Biologics Development Lead

The Associate Director, Ext QA Biologics Development Lead is responsible for prospecting and converting prospects to leads regarding quality aspects. This role will work very closely with the Business Development and Pharmaceutical Biologics Development to build a strong understanding of the biotech prospects from a quality perspective. Typical business development work includes technology selection, technology characterization, risk management compliance, collaboration with external vendors and CMOs, appropriate interpretation of development work to ensure programs are adequately assessed and quality risk are defined and/or mitigated.

Role and Responsibilities:

The primary responsibility of this role is to:
  • Participate on Due Diligence activities as Biologics Quality representative on cross functional Due Diligence teams assessing new business opportunities, including, but not limited to, new Partner Collaborations and Acquisitions.
  • Conduct due diligence site visits and initial GMP audits as part of a broader team, identifying quality risks and assessing potential cost of quality.
  • Assist with integration of new acquisitions and onboarding of new partner collaborations, including assessment of Regulatory and Audit commitments,
  • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards, CMO oversight, and procedures when necessary
  • Hold key expert quality and technical knowledge for assigned products within the biotechnology product portfolio.
  • Represent Biologics Quality functions to enable informed decision making for assigned products.
  • Support adherence of product development, manufacturing, and logistics operations with applicable regulatory agencies
  • Assist with Regulatory Submissions


Essential Duties and Job Functions:
  • Direct efficient expert network with site Quality and business functions.
  • Represent Biologics Quality on Due Diligence initiatives.
  • Share key knowledge for business decisions.
  • Partner as product key expert with e.g., Regulatory, Development Operations, Supply Chain Management (SCM), Marketing, Commercial, Affiliates, Technical Services, etc., for Biotech Products.
  • Follow up on remediation activities.
  • Lead Quality Integration teams, working across various Quality and Business functions.
  • Partner as Biotech product key expert within PDM Quality to enable informed decisions related to e.g., issue management, change management.


This role can be based out of our Morris Plains, NJ, Oceanside, CA, or Foster City, CA site.

Knowledge, Experience and Skills:
  • Biotech Product expertise or an equivalent combination of education and experience.
  • Expert in conducting/leading GMP audits of CXOs.
  • Quality Assurance experience and knowledge of biotechnology processing and testing.
  • Demonstrated experience leading cross-functional teams and influencing through indirect leadership to build collaboration and drive resolution.
  • An in-depth knowledge of pharmaceutical analytical technologies, including sterile manufacturing and packaging, and distribution including all governmental and agency regulations.
  • Broad cGMP experience and knowledge, Quality Assurance (QA)/Quality Control (QC) and regulatory compliance (U.S. and other international agencies).
  • Business process management and stakeholder management skills.
  • A working knowledge of statistics and computerization (electronic documentation) of QA Data.
  • Ability to communicate effectively with people at all levels in the organization, from other departments and divisions, as well as regulatory agencies.
  • Navigate matrix organizations and support multiple business processes.
  • Strong leadership and interpersonal skills, excellent communication, presentation and influencing skills, change management experience and skills, very good partnering and networking skills, ability to build on diversity and inclusion.


Basic Qualifications:
  • 10+ years of relevant experience and a bachelor's degree in science or related fields. OR 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
  • Product expertise or an equivalent combination of education and experience.
  • Quality Assurance experience and knowledge of biotechnology processing and testing.
  • Demonstrated experience leading cross-functional teams and influencing through indirect leadership to build collaboration and drive resolution.
  • Experienced GMP Auditor.
  • An in-depth knowledge of pharmaceutical analytical technologies, including sterile manufacturing and packaging, and distribution including all governmental and agency regulations.
  • Expertise and knowledge in Good Manufacturing Practices (GMP) facilities and equipment design concepts to review projects for compliance impact.
  • Broad cGMP experience and knowledge, Quality Assurance (QA)/Quality Control (QC) and regulatory compliance (U.S. and other international agencies).
  • Business process management and stakeholder management skills.
  • A working knowledge of statistics and computerization (electronic documentation) of QA Data.
  • Ability to communicate effectively with people at all levels in the organization, from other departments and divisions, as well as regulatory agencies.
  • Navigate matrix organizations and support multiple business processes.
  • Strong leadership and interpersonal skills, excellent communication, presentation and influencing skills, change management experience and skills, very good partnering and networking skills, ability to build on diversity and inclusion.


Preferred Qualifications:
  • Experience in Biotech


If this is not the right move for you now but remain interested in a career at Gilead Sciences, please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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For jobs in the United States:


As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic 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 laws. In 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the 'Know 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 log onto your Internal Career Site to apply for this job.






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Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Find Us
Website
Location
333 Lakeside Drive
Foster City
California
94404
US
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