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Gilead

QC Team Lead

For Current Gilead Employees and Contractors:

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

Job Description

About Gilead

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.

The QC Team Lead will be responsible for the following:

  • Lead a team of QC Analysts, including overseeing training, holding 1:1 meetings with all direct reports, and spending at least two hours per day on the laboratory floor with the analysts
  • Ensure analysts understand and are accountable for department performance initiatives
  • Schedule Raw Material laboratory testing to meet deadlines
  • Issue Analytical Reports and Certificates of Analysis
  • Own CAPAs pertaining to QC, review non-tests and issue quarterly non-test report; report events to QC management as appropriate 
  • Ensure analysts have all the supplies necessary to perform testing; run MDI board and meetings 
  • Write and implement SOPs, Methods, Protocols, and Reports 
  • Maintain safe working conditions
  • Attend cross-departmental meetings as necessary   
  • Clear, concise verbal and written communication
  • Ability to troubleshoot various laboratory instruments
  • Ability to persevere through and commit to difficult or tedious tasks
  • Quick and flexible to changing priorities 
  • Be trustworthy and fair – build and maintain trust with both employees and colleagues
  • Exhibit a passion for excellence in the Quality Control Laboratory 

Essential Duties and Job Functions:

  • Leads assigned group of staff in the QC department.
  • Acts as advisor and technical resource to more junior staff.
  • This is an advanced position requiring significant expertise/specialization in QC instrumentation, which may support either QC Chemistry or Microbiology as part of day to day responsibilities.
  • Supervises more junior staff, including organizing and prioritizing daily tasks, and performing training.
  • Oversees the daily activities of team, ensuring that Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements are followed.
  • Organizes, plans and schedules section operations to minimize delays, while complying with all cGMP and safety regulations.
  • Responsible for implementing new instrumentation and procedures into the compliance environment.
  • Reviews the work of more junior staff for accuracy and consistency.
  • Prepares and submits equipment/instrument validation reports for review and approval.
  • Implements compliant systems relating to new instrumentation and computerized systems.
  • Arranges for equipment service, calibration, and repair.
  • Responsible for developing technical solutions for semi routine to moderately complex projects and issues related to QC instrumentation and the instrumentation qualification process.
  • Proposes, implements, and qualifies new instrumentation and equipment to improve processes and/or ensure compliance with GMP’s and other regulatory requirements.
  • Provides QC technical expertise and counsel.
  • Writes and executes protocols and reports.
  • Troubleshoots instrumentation and test methods.
  • Evaluates equipment for purchase and performs installations and qualifications of the new instruments.
  • May lead or coordinate QC and cross-functional projects.

Knowledge, Experience and Skills:

  • 6+ years of relevant experience and a BS or BA.
  • 4+ years of relevant experience and a MS.
  • Prior experience in pharmaceutical industry is strongly preferred.
  • Supervisory experience is strongly preferred
  • Working knowledge of GMPs, GLPs, pharmacopoeial, and regulatory requirements for instrumentation, equipment and testing pertaining to the pharmaceutical industry is required.
  • Project Management and prioritization skills.
  • Audit and Investigation Skills, Report Writing Skills.
  • Strong verbal, technical writing and interpersonal skills are required.
  • Proficiency in Microsoft Office applications.
  • Advanced excel skills for Metric reporting.
  • Proficient in quality control systems, quality management systems, process and procedures for instrument qualification.


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.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ 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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