Sr Director of Biologics: Head of Technical, Characterization, and Validation for Biologics

Job Description

Senior Director of Biologics: Technical, Validation, and Knowledge Management

The Sr. Director role provides technical expertise and leadership for a team of professionals with specific focus on the creation and implementation of a process characterization and validation (PCPV) program, including the relevant processes and infrastructure that support the design, development, manufacture, and regulatory submission of biologics pharmaceutical products. Technical areas include process characterization and validation, commercialization operations, quality risk management, quality management systems, training, compliance, cGMP and regulatory documentation.

The Sr. Director enables and supports the team to deliver on a defined vision and influences others to achieve aligned results and objectives while working in a complex environment, operating across a broad network.

The Sr. Director will participate in organizational design activities and is responsible for coaching, developing, and engaging the team.

Qualifications

• Education: B.S. or B.A. degree (with preference for Life Science or Engineering focus)
• Experience: 15+ years of relevant leadership and validation experience in the pharmaceutical or biopharmaceutical industry
• Proven experience with developing and executing a process validation program and activities
• Sound knowledge of technical development activities, cGMP regulatory requirements, and industry trends/expectations
• Experience with strategic planning and demonstrated delivery of results
• Experience in late-stage regulatory submission preparation and regulatory filings
• Proven ability to communicate clearly and professionally both in writing and verbally with customers, peers, senior management, and health authorities
• Ability to travel up to 20%

Preferred Skills/ Knowledge

• Demonstrated track-record of coaching, directing, and motivating successful organization functions
• Demonstrated experience with change management, organization design, and leading an organizational transformation
• Strong leadership abilities to work cross functionally in a global environment and with diverse teams
• Demonstrated successful collaboration and relationship building skills
• Ability to think both strategically and tactically, with strong problem-solving skills
• Demonstrated expertise with influencing, and providing direction to meet business objectives
• Courage to take the lead in unique or unprecedented situations

Key Responsibilities

• Manage and administer all aspects of people processes related to the employee life cycle (selection, hiring and training of personnel, goal setting, providing feedback)
• Provide guidance and coaching to the team, while empowering them to make decisions.
• Develop an organization with a culture of trust and behaviors that align with company core values
• Promote an environment in which cultural aspirations are supported and employees can flourish
• Enhance Diversity and Inclusion efforts within the team/function
• Provide leadership and strategic vision for process validation activities during process development, throughout the initial product launch, and for post-approval activities
• Interface with technical development and the manufacturing organization to develop and implement process characterization and validation processes and best practices
• Serve as SPOC for biologics process validation issues that may arise from internal and external audits or inspections, support resolution of PV observations, and drive alignment with site validation and QA.
• Develop and implement a strategy for Knowledge Management, including business processes and tools to manage process knowledge and support continuous improvement
• Provide leadership and strategic vision to deliver results and enable compliance with a strong quality mindset, technical expertise, and pragmatic solutions
• Develop team objectives, as well as overall vision, long-range goals, and department budget
• Partner with various functions and technical SMEs to provide aligned vision and goals
• Proactively identify and implement pragmatic solutions to resolve complex risks/ issues
• Partner with customers, stakeholders, and senior management to deliver functional activities
• Identify, support, and participate in continuous improvement initiatives and opportunities, including ones that have multi-team and inter-organizational impact

Gilead Core Values
• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 careers@gilead.com for assistance.