Exec Director, MSAT

Описание вакансии

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