The posting
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 Sr Manager of QC will report to the Head of QC and will be a key member of the QC leadership team.
QC Operations: Set direction and coordinate QC priorities for the testing and release of raw materials, primary and secondary packaging components, and finished product. Align team delivery with business needs and ensure work is performed in accordance with approved methods, specifications and applicable requirements.
Quality and Compliance: Champion quality and compliance across the team. Establish clear expectations and oversight to ensure laboratory activities and documentation meet cGMP, data integrity, regulatory and applicable pharmacopoeial requirements.
Investigations and CAPA: Lead the team’s response to out-of-specification (OOS) and out-of-trend (OOT) results, deviations, atypical results and laboratory investigations. Provide technical oversight and direction for root-cause analysis, impact assessment and corrective and preventive action (CAPA) support.
Technical Leadership: Provide technical direction and guide sound decision-making in analytical data review, troubleshooting and laboratory problem-solving. Ensure appropriate oversight of analytical methods, instrumentation and controlled laboratory systems.
People Leadership: Lead, coach and develop QC personnel, translating priorities into clear expectations and shared accountability. Build team capability through regular feedback and development support. Empower team members to take ownership and foster open, respectful dialogue and effective collaboration.
Cross-functional Leadership: Represent QC and build alignment with internal and external groups on method transfers, new technologies and equipment. Influence cross-functional decisions by communicating QC priorities and technical information clearly to senior management and external stakeholders, as applicable.
External and Supplier Support: Provide QC leadership in partnerships with external suppliers or quality representatives. Build alignment on the resolution of quality-related issues.
Inspection Readiness: Lead a proactive, inspection-ready laboratory culture with a strong focus on data integrity. Direct the identification of compliance risks, trends and systemic issues through inspection-readiness walkabouts and establish accountability for tracking and addressing appropriate actions.
Continuous Improvement: Champion continuous improvement and operational excellence. Lead the team in identifying and implementing improvements to laboratory processes, efficiency and ways of working while maintaining compliance.
Knowledge: Excellent communication and strong interpersonal skills are required. Must be able to participate in highly effective teams. Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills. In depth working knowledge of GMPs, pharmacopoeia, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required. Proven leadership ability and problem-solving skills. In depth knowledge of current industry trends and conventions is required. Must have excellent analytical and computer skills.
Specific Education & Experience Requirements: Extensive experience and a BS/MS. Knowledge and experience in quality control in a highly regulated manufacturing environment is a plus. Prior people management experience is preferred. Biopharmaceutical or Pharmaceutical experience is a plus.
Specific Job Responsibilities: Manages the Quality Control Chemistry laboratory operation, ensuring laboratory processes provide high quality analytical support for manufacturing, maintenance, engineering and validation operations while ensuring compliance of protocols, GMPs, and safety regulations. Provides broad-based QC Chemistry expertise and counsel to and on behalf of the organization. Provides leadership, management, and training and career coaching for QC staff. Responsible for the management, guidance and training of QC Team Leaders, Chemists, Microbiologists and Technicians. Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers. Participates in regulatory audits as required.
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.
