Sr Manager, Quality Assurance

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations. Join Gilead and help create possible, together.

Job Description

The role supports QA function's commitment to operating in accordance with cGMP and maintaining a quality system that ensures compliance with regulatory requirements.

We are looking for a QA professional to provide leadership and direction for Quality Systems, ensuring the effective operation and continuous improvement of the site Quality Management System within a highly regulated pharmaceutical manufacturing environment. Lead through clear expectations, robust Quality System oversight, effective use of quality data, people development and cross-functional collaboration. Promote a strong culture of quality, compliance, data integrity, accountability and continuous improvement

Key Responsibilities

• Quality Management Systems
• Provide leadership and oversight for Quality Systems activities, ensuring effective implementation and maintenance of the Quality Management System. Ensure activities are conducted in accordance with established SOPs, company and departmental policies and procedures, cGMP and applicable regulatory requirements.

• Quality System Performance & Management Review
• Establish effective oversight of Quality System performance through appropriate metrics, trending and review of quality data. Use Quality System information to assess effectiveness, identify emerging issues and opportunities for improvement, and support effective Quality Management Review and management decision-making.

• Compliance & Regulatory Standards
• Maintain current knowledge of relevant manufacturing standards, product regulations and global regulatory requirements. Provide Quality Systems leadership to support consistent application of regulatory and company requirements and promote a strong culture of compliance across the site.

Complaint and APQRs

Provide leadership and quality oversight for the Product Complaint and APQR Quality Systems, ensuring regulatory compliance, effective governance and continuous improvement. Maintain oversight of investigation quality, complaint and product-quality trends, APQR execution and identification of emerging or systemic risks. Ensure significant trends and cross-functional or cross-site issues are appropriately escalated through Quality governance and translated into meaningful corrective, preventive and continuous improvement actions.

• Data Integrity & Electronic Quality Systems
• Ensure Quality Management Systems are maintained in alignment with data integrity principles. Support the effective use of relevant electronic systems and software used in Quality Systems activities, including electronic document and learning management systems as applicable.

• Cross-functional Leadership
• Build strong working relationships with internal and external business partners. Collaborate across functions and the global network to exchange information, solve problems, coordinate actions and address compliance issues associated with the Quality Systems environment

• Inspection, PAI & Self Inspection Readiness
• Promote sustained inspection and audit readiness across Quality Systems by maintaining appropriate Quality System oversight and supporting compliant, accurate and controlled records and processes. Reinforce ownership of identified Quality System issues and support effective resolution and continuous improvement. GSIUC's Self Inspections and QA walkthroughs demonstrates the site's ongoing GMP audit environment, including review of documentation, procedures and laboratory activities.

• Continuous Improvement
• Champion continuous improvement across Quality Systems and the wider business. Use quality metrics, trends and cross-functional problem solving to identify opportunities to strengthen Quality System effectiveness, simplify ways of working and support sustainable improvements while maintaining compliance.

• People Leadership
• Lead, coach and develop Quality Systems personnel, translating Quality and business priorities into clear expectations and shared accountability. Build team capability through regular feedback and development support, empower individuals to take ownership, and foster open, respectful and effective collaboration.

Requirements:

Bachelor’s degree in science or related discipline required; advanced scientific or business degree preferred.

Significant experience in Quality within a regulated pharmaceutical or biopharmaceutical manufacturing environment.

Prior Quality leadership experience

Strong knowledge of Quality Management Systems, cGMP and relevant global regulatory requirements.

• •Strong understanding of data integrity principles and their application within Quality Management Systems.
• •Ability to use Quality System metrics, trends and data to evaluate system effectiveness and identify opportunities for improvement.

• •Strong problem-solving, risk-based decision-making and continuous-improvement capability.
• •Strong people leadership, coaching and team-development skills, with the ability to establish clear expectations and accountability.

Strong communication and stakeholder-management skills, with the ability to build effective relationships and collaborate across internal and external groups.

Ability to communicate Quality System and compliance matters clearly and support effective cross-functional decision-making.

Working knowledge of relevant electronic Quality Systems and software.

• •Ability to manage competing priorities and translate Quality and business requirements into clear team priorities.
• •Commitment to maintaining a strong culture of quality, compliance, data integrity, accountability and continuous improvement.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.