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Associate Director – External QA Biologics Development Lead
Confirmed live in the last 24 hours
Locations
Oceanside, CA, USA • Morristown, NJ, USA • San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Communications
Mergers & Acquisitions (M&A)
Quality Assurance (QA)
Requirements
  • 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
  • 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
Responsibilities
  • 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
  • Direct efficient expert network with site Quality and business functions
  • Represent Biologics Quality on Due Diligence initiatives
Desired Qualifications
  • Experience in Biotech
Gilead Sciences

10,001+ employees

Critical disease biopharmaceutical development
Company Overview
Gilead’s mission is to discover, develop and deliver innovative therapeutics for people with life-threatening diseases. The company is committed to creating a healthier world for everyone through their research, development of forward medicines, and clinical trials.
Benefits
  • Paid family time off and paid parental time off
  • Generous 401(k) contribution matching
  • Comprehensive medical plans that cover both physical and mental healthcare
  • Global Wellbeing Reimbursement
  • Time Off
  • Global Volunteer Day
  • Giving Together Program
  • Employee Support Programs
  • Flexible Work Options
Company Core Values
  • Integrity: Doing What’s Right
  • Inclusion: Encouraging Diversity
  • Teamwork: Working Together
  • Accountability: Taking Personal Responsibility
  • Excellence: Being Your Best