Senior Manager, Quality Control

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 fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. 

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.  

As the Senior Manager, Quality Control at Gilead you will manage the Quality Control Chemistry or Microbiology 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.

Responsibilities:​

• Manages QC personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.

• Oversees overall day-to-day operation of laboratories.

• Attends specific project related team meetings and address items pertaining to project as assigned by direct manager.

• Writes and/or implements changes to controlled documents (e.g., SOPs, Software Specifications, Methods, etc.) as needed.

• Follows technology changes, recommends new technologies, purchase and implement if appropriate.

• Leads and coordinates defined projects/initiatives and investigations - works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.

• Exercises good judgment within general defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining analytical results.

• Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors; considerable judgment is required in resolving problems and making routine recommendations.

• Provides broad-based QC Chemistry or Microbiology expertise and counsel to and on behalf of the organization.

• Provides leadership, management, training and career coaching for QC staff.

• Provides data review, process trending, and procedural updates and provide technical support for qualification protocol writing.

• 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.

• Directs team activities, adhering to schedule, budget and resource requirements.

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.

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