Director, Commercial Analytical Operations — Biologics Quality Control

Job Description

Director, Commercial Analytical Operations — Biologics Quality Control

KEY RESPONSIBILITIES:

The Director Commercial Analytical Operations is vital for the success of Commercial Biologics QC, providing strategic leadership and overseeing daily operations. Responsibilities include leading the cGMP QC team that manages the release testing and stability program supporting Gilead’s commercial biologics drug substances and drug products. The role is accountable for refining QC procedures across Gilead’s biologics manufacturing network, ensuring compliance with global cGMP and Gilead’s Quality Management System. The Director collaborates with cross-functional teams, fosters a culture of continuous improvement, and offers mentorship to the QC team for timely project completion and regulatory compliance.

FOCUS AREAS

You Will:

• Oversee the development and implementation of end-to-end Quality Control strategy for Gilead’s portfolio of biologics products.
• Have ultimate responsibility for staff development, and contribute to budgeting, cost control, and strategic planning of the Biologics Quality Control department. Provide leadership and guidance to direct reports and project team members to develop strong leaders at Gilead.
• Lead, motivate, and develop the team, routinely making decisions to ensure project timelines are met.
• Ensure that Quality Control Systems and practices are developed and implemented across all international affiliates, contract manufacturing sites and contract laboratories for commercial biologics.
• Demonstrate a clear understanding of biological product testing methods and assays for effective troubleshooting, and remediation of atypical results. Act as an escalation point for complex/high impact quality control issues/decisions.
• Identify, select, manage, and evaluate CMOs/CTLs, consultants etc. to control quality in support of achieving PDM’s strategic objectives. Establish clear expectations, metrics and KPIs, as appropriate to monitor QC operations and analytical method performance.
• Be accountable for reviewing data and troubleshooting analytical testing within the Biologics portfolio across external network partners.
• Contribute to Annual Product Quality Reviews, Regulatory Filings, and responses to Information Requests from Regulatory Agencies.
• Interface with Regulatory agencies as required representing Gilead to authorities and regulatory inspectorates in matters relating to QC operations and stability studies.
• Lead or serve as a key project team member on large cross functional projects, often with high visibility to senior management within the organization or with international impact.
• Provide a long-term view to senior QC Leadership based on personal knowledge of the competitive environment.
• Lead standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Control Systems

REQUIREMENTS

You have:

• Experience over a broad set of Quality Control sub-functions with extensive knowledge of industry best practices and trends.
• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness.
• Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.
• Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.
• Demonstrated experience and ability to manage and lead staff, with strong hiring and staff development skills, and the ability to motivate and engage individuals.
• Demonstrated the ability to influence process and outcomes across functions.

QUALIFICATIONS:

• Ph.D. with 8+ years experience OR M.S. with 10+ years experience OR B.S. with 12+ years industrial 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 Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting trends in industry.
• Prior senior leadership experience required.
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
• Strong organizational and planning skills.
• Shows excellent verbal and written communication skills and collaborative interpersonal skills.

Gilead Core Values

Integrity (Doing What’s Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)