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.
Specific Education & Experience Requirements:
- 8+ years of relevant industry experience and a BS.
- 6+ years of relevant industry experience and a MS.
- 2+ years of relevant industry experience and a PhD
- Knowledge and experience in quality control in a highly regulated manufacturing environment
Preferred:
- Prior people management experience is preferred.
- Biopharmaceutical or Pharmaceutical experience is a plus.
People Leader Accountabilities:
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
