Senior Director, Quality Control Analytical Sciences
Abata TherapeuticsSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries
Requirements
- Ability to multitask/prioritize
- Excellent written and oral communication skills
- Decision making ability
- Interpersonal skills
- Ability to anticipate potential problems and develop/implement solutions
- Leadership role in quality systems implementation and influencing improved/streamlined quality systems
Responsibilities
- Oversight and execution of product testing, including Chemical and/or Micro tests for raw materials, in-process samples, semi-finished and finished products, physical and functional testing of Drug/Device combination products, and visual/physical testing of packaging components
- Ensuring an adequate quality system for material and product testing, including instructions/procedures, qualified testing equipment/instruments, and trained personnel
- Resourcing the quality control unit and continuous professional development of the quality control team as a member of the site management team
- Serving as Site/Plant agent to manage compliance to all cGMP, procedures, policies, and guidelines, and supporting development of the business plan
- Maintaining a safe work environment, leading safety initiatives, working safely, and supporting HSE Corporate and Site Goals
- Participating in Human Resource Development, Human Resource Planning, and Performance Management for direct reports; participating on the plant lead team and Parenteral Quality Lead Team
- Serving as a conduit for Corporate communications and exhibiting critical business decision making
- Creating and managing Site Quality Plan; recruiting new talent; ensuring technical and compliance consistency across plants; coordinating and managing regulatory inspections
- Communicating with and integrating support groups outside the plant
- Recruiting/retaining effective diverse staff, supervising, coaching, aiding development, performance management, and ensuring a fair/equitable work environment
- Providing technical support and expertise for site and Corporate on analytical topics
- Defining and maintaining inspection readiness activities; interacting with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility issues
- Networking internally/externally to understand best practices, share knowledge, participate in tactical/strategic business planning, and ensure customer needs are met
- Networking with other sites on new systems development and best practices for analytical processes
- Developing plan for capital purchases
- Approving/rejecting starting materials, packaging materials, intermediates, bulk, and finished products
- Ensuring all necessary testing is carried out and associated records evaluated
- Approving specifications, sampling instructions, test methods, and other Quality Control procedures
- Approving and monitoring contract analysts
- Ensuring qualification and maintenance of testing equipment/instruments
Skills
cGMP
Quality Control
Chemical Testing
Microbiological Testing
Laboratory Management
Equipment Qualification
Personnel Training
GMP Compliance
Safety Initiatives
HSE
Eli Lilly and Company
Develops and delivers prescription medicines globally
About Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.
Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees