Director, QA Analytical Science and Technology

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 ensure the health and safety of our teams.

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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.

Director, QA Analytical Science and Technology

The successful candidate will possess a detailed understanding of Analytical QA in support of large molecule manufacturing as well as demonstrated success in organizational leadership and building high performing teams. The candidate must be highly motivated to contribute to the development of biologics targeting unmet medical need through the establishment and leadership of a team supporting multiple clinical and commercial programs. This role will have responsibility for supporting GMP activities at as multiple external contract testing sites, internal and external method establishment, product performance monitoring, existing methods and specifications, reference standard programs, QC impacting change controls, and analytical investigation oversight

Location: The candidate can sit out of our Foster City, CA, Oceanside, CA or Morris Plain, NJ site

Role and Responsibilities:

Leads a team in providing QA oversight to PDM Biologics Analytical Operation and contract test partners (i.e., CTLs and CMO Labs) in support of analytical testing activities across clinical and commercial programs for external manufacturing operations.

• Leads the review and approval of method validation and transfer related documentation and exception events; ability to coach and train team and cross-functional colleagues to ensure cGMP compliance to these specific areas.

• Manages daily QA team activities, guiding major planned changes and exceptions, method validation and transfer related documents, deviations, investigations, and provides support and training to staff members.

• Reviews and improves existing quality procedure workflows, identifies areas of improvement for efficiency and compliance, and leads implementation efforts in collaboration with cross-functional stakeholders.

• Serves as QA project lead, leads complex quality issues and events, represents QA on Materials Review Boards and escalations, and independently authors or approves concise quality investigation reports with appropriate corrective action and preventive actions (CAPA).

• Expert in laboratory controls and method validation per FDA/EU/ICH/USP guidelines, leads team in a wide variety of quality assurance activities, and provides support and training to staff members.

•Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits.

• Demonstrated ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.

Key Responsibilities

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements

• Reviews and approves controlled documents (e.g., SOPs, specifications, methods, change control, protocols, reports, investigations, deviations, CAPAs, etc.) to ensure defined quality objectives are met.

• Interfaces with operating entities and contract partners to address documentation and compliance issues.

• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).

• Reviews and audits method validation related data in CMC sections of NDA / global filings.

• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.

• Supports cGMP supplier audits and health authority inspections at contract partners and may interface with regulatory agencies during inspections

Knowledge, Experience and Skills:

• 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.
• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
• Prior people management experience.
• Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, Aseptic and API operations is beneficial.
• Biopharmaceutical or Pharmaceutical experience preferred.

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:

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 Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Summary

• Location: United States - New Jersey - Morris Plains; United States - California - Oceanside; United States - California - Foster City
• Type: Full time