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Sr Director, Validation Pharmaceutical Manufacturing

Job Description The qualified candidate: Provides leadership and guidance to direct reports and project team members in an effort to develop strong leaders at Gilead. Accountable for developing action plans for the future implementation of systems to meet long-term objectives. Makes key decisions and formulates policies that impact strategic objectives of the department. Initiates collaboration across Gilead to solve business problems and create competitive advantage. Acts as an escalation point for complex/high impact quality issues/decisions. Provides a long-term view to senior validation Leadership based on personal knowledge of the competitive environment. Develops key performance metrics that measure impact and effectiveness of the function. Develops software and business requirements for systems that support validation. Job Responsibilities: 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. Serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations. 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. Knowledge, Experience, and Skills: 12-15 years of relevant experience and bachelor's degree in science or related field. Prior people management experience. An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable. Deep knowledge and experience in validation in highly regulated manufacturing environments is preferred. Biopharmaceutical or Pharmaceutical experiencepreferred. Must have in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally. Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness. Able to exercise judgment and independently determine and take appropriate action where precedent may not exist. Demonstrates extensive knowledge of industry best practices and trends. Excellent verbal, written, and interpersonal communication skills are required. Requires experience and ability to manage staff. #LI-JS1 R0005329
Salary Range: NA
Minimum Qualification
11 - 15 years

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