Assoc Director, Validation

Assoc Director, Validation

United States - California - La Verne Manufacturing Operations & Supply Chain Regular

• Lead strategy and execution of complex sterile product qualification activities.
• Expertise in contamination control, cleaning validation and isolator systems.
• Adopt best practices for continuous qualification of sterile production facilities.
• Provides relevant CMC support for sterile products pre- and post-approval filings.
• Interface with Senior Leadership Team to provide a unified set of goals and objectives for the Validation team.
• Assist with onboarding of new technologies and provide oversight for new qualification programs.
• Work with Quality to adopt an effective quality management system and achieve the quality objectives.
• Provide leadership for Validation team and ensure growth and development of staff to meet changing business needs.
• Forecast external support requirements for continuous validation support, including implementation of new projects.
• Ensure continuing suitability and effectiveness of the quality management system and GMP compliance through participation in management review.
• Oversee the development and implementation of validation strategy for Gilead portfolio of products and/or across engineering and validation sub-functions.
• Collaborates cross-functionally and geographically with stakeholders to ensure that product distribution and validation processes are aligned to the needs of Gilead and its customers, ensuring that best practice, compliance and alignment with business needs.
• Works directly with international affiliates and distributors to ensure that regulatory inspections are managed in accordance with Gilead corporate guidelines and responses are submitted in accordance with regulatory requirements.
• Conducts and serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations related to distribution 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.

• Bachelor’s degree in engineering or physical/life sciences and at least 10 years of relevant experience (Chemical Engineering, Bioengineering, Chemistry, or Biochemistry).
• Knowledgeable of the principles of GxPs.
• Expertise in aseptic manufacturing principles, including production of complex injectable formulations, contamination control, cleaning validation and isolator technology.
• Deep understanding of Regulatory requirements for US, EU and developing markets for Validation function.
• 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.
• Demonstrate extensive knowledge of industry best practices and trends.
• Excellent verbal, written, and interpersonal communications skills are required.
• Requires successful experience and ability to manage staff, both FTEs and contractors.
• Injectable product experience (biologics or pharmaceutical) required.
• Deep knowledge and experience in process development/engineering, technical services or validation is required.
• Has successful experience managing technical staff.

• Master’s Degree in engineering or physical/life sciences and at least 8 years of relevant experience (Chemical Engineering, Bioengineering, Chemistry, or Biochemistry).

OR

• Ph.D. in engineering or physical/life sciences and at least 5 years of relevant experience (Chemical Engineering, Bioengineering, Chemistry, or Biochemistry)