Exec Director, MSAT

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s 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 we’re 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
 

Job Responsibilities

• Provide leadership related to best Practices pertaining to tech transfer and validation

• Interface with Senior Leadership Team to provide a unified set of goals and objectives for the dept.

• Assist with onboarding of new technologies and provide oversight for new qualification programs.

• Ensure growth and development of staff to meet changing business needs.

• Conducts and serves as a lead/coordinator of investigations and corrective and preventative action

(CAPA) recommendations related to tech services and validation activities.

• Interfaces with Regulatory agencies as required representing Gilead to authorities and regulatory

inspectorates in matters relating to GMP.

• Leads standardization and harmonization of Standard Operating Procedures, leveraging existing

Gilead Quality Systems.

• Ensure coordination and synchronization between the two groups (tech transfer and validation) for the benefit of new product introduction or projects

1/ Tech Services

• Lead strategic and tactical operations of a team across the Technical Services Department. Ultimate responsibility for staff development, budgeting and cost control, and strategic planning of a Technical Services department.
• Provides direction and assistance on resolution of complex issues, and potential problems related to multiple drug forms.
• Accountable for developing action plans for future implementation of systems to meet long-term objectives.
• Acts as an escalation point for complex/high impact technical services issues/decisions.
• May lead cross-functional PDM teams for a program with responsibility for the planning and execution of program strategy through all stages of development.
• For commercial manufacturing, leads commercial projects with responsibility and accountability for commercial process performance, CPV, optimization, and investigations.
• Directs the planning and execution of process development while considering process efficiency, scalability, safety, regulatory factors, and cost of goods.
• May act as an advisor to senior management on process development and corporate research and development direction.

• Determines organizational objectives and interprets company policies to meet company goals.
• Reviews and approves capital expenditure.
•  Ensures that all departments operate in accordance with department SOPs which meet regulatory and GMP standards.
• Liaises with Pharmaceutical Manufacturing and Pharmaceutical Development teams across Gilead on the technical transfer of new products across identified sites.
• May serve as liaison between the company and various governmental agencies.
• Assists in any investigation within the company including but not limited to the handling of deviations, complaints, Out of Specification Investigations, Material Review Boards, associated investigations, finished product trending, and change control.

2/ Validation

• Oversee the development and implementation of commissioning and validation strategy for Gilead portfolio of products and/or across engineering and validation sub-functions.
• Manages the strategic and tactical operations of the validation department.
• Ultimate responsibility for staff development, budgeting and cost control, and strategic planning of the validation department.
• Oversees the development and implementation of validation strategy for Gilead portfolio of products and/or across validation sub-functions.
• Establishes and publishes Key Performance Indicators to track GMP, GDP compliance across operations.
• Works with senior and executive management, develops plans and strategic direction for the validation function
• Collaborates cross-functionally with stakeholders to ensure that product validation processes are aligned to the needs of Gilead and its customers, ensuring that best practice, compliance and alignment with business needs.

Knowledge & Skills

• Demonstrates extensive knowledge of industry best practices and trends.
• Is able to develop and improve complex concepts, techniques, standards and new applications. Is able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.
• Is able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Demonstrates exceptional verbal, written, and interpersonal communication skills.
• Has proven experience and ability to manage staff.
• Demonstrates deep knowledge and experience in technical services as well as industry best practices and trends
• Must have in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.

Education & Experience

• Education & Experience

• 16+ years of experience in the pharmaceutical industry and a BS or BA OR 14+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
• Prior people management and leadership experience.
• Deep knowledge and experience in validation and tech transfer in highly regulated manufacturing environments is preferred.
• Experience with Biologics Products and Sterile manufacturing.
• Biopharmaceutical or Pharmaceutical experience required.
• Must be willing to be based out of the La Verne, CA site

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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