Sr. Director - QC Labs IPM

Eli Lilly and Company • Us, IN

12d

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Position Brand Description: The Senior Director - QC Labs IPM is responsible for the oversight and execution of the 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 product and visual and physical testing of packaging components. Responsible for ensuring there is an adequate quality system in place for material and product testing, including instructions and procedures to execute the testing, that testing equipment and instruments are qualified, and personnel trained. As member of site management team, they are responsible for the adequate resourcing of the quality control unit and the continuous professional development of the quality control team. This position requires the ability to multitask / prioritize, excellent written and oral communication skills, decision making ability, interpersonal skills, as well as the ability to anticipate potential problems then develop / implement solutions. This role will serve as a Site / Plant agent to manage compliance to all cGMP, procedures, policies, and guidelines, and support development of the business plan. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals. Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports; participate on the plant lead team and Parenteral Quality Lead Team. Serve as a conduit for corporate communications; exhibit critical business decision making bringing about successful results. Create and manage Site Quality Plan; recruit new talent, technical and compliance consistency across plants; coordinate and manage regulatory inspections. Communicate to and strive for integration of support groups outside of the plant. Recruit / retain effective diverse staff, supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment. Leadership role in the implementation of quality systems. Influence development of improved and streamlined quality systems. Provide technical support and expertise for site and Corporate on analytical topics. Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility issues. Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure customer needs are met Network with other sites regarding new systems development and best practices for analytical processes Develop plan for capital purchases Although authorized members of the Quality control unit can perform the activities listed in this section, this role maintains ultimate responsibility for the following: To approve or reject, as they see fit, starting materials, packaging materials, intermediate, bulk, and finished products. To ensure that all necessary testing is carried out and the associated records evaluated. To approve specifications, sampling instructions, test methods, and other Quality Control procedures. To approve and monitor any contract analysts. To ensure the qualification and maintenance of their department, premises, and equipment. To ensure that the appropriate validations are done. To ensure that the required initial and continuing training of their department personnel is carried out and adapted according to need. To ensure adequate design, effective implementation, monitoring, and maintenance of the quality management system. These may include, subject to any national regulations The authorization of written procedures and other documents, including amendments. The monitoring and control of the manufacturing environment. Plant hygiene. Process validation. Training. The approval and monitoring of suppliers of materials. The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities. The designation and monitoring of storage conditions for materials and products. The retention of records. The monitoring of compliance with the requirements of Good Manufacturing Practice. The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality. Participation in management reviews of process performance, product quality, and of the quality management system and advocating continual improvement Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.

Requirements

• Bachelors of Science degree in Chemistry, Microbiology, or related science field.
• 10+ years of experience in pharmaceutical industry with previous supervisory experience.
• High-quality skills to include ability to prioritize, written and oral communication, critical decision making, interpersonal / people, computer applications, problem solving, mentoring / leadership
• Self-motivation, lead the way for ensuring a fair and equitable work environment; clear understanding of all cGMPs, policies, procedures, and guidelines
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals

Nice To Haves

• Experience in Production, Quality Control, Quality Assurance, Technical Services, Regulatory, or Administration is desirable.
• Previous analytical and/or micro experience.
• Experience interacting with regulatory agencies.
• In-depth understanding of chemistry and/or microbiology principles relating to pharmaceutical products.
• Deep understanding of compliance requirements and regulatory expectations relating to material and product testing.

Responsibilities

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports; participate on the plant lead team and Parenteral Quality Lead Team.
• Serve as a conduit for corporate communications; exhibit critical business decision making bringing about successful results.
• Create and manage Site Quality Plan; recruit new talent, technical and compliance consistency across plants; coordinate and manage regulatory inspections.
• Communicate to and strive for integration of support groups outside of the plant.
• Recruit / retain effective diverse staff, supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment.
• Leadership role in the implementation of quality systems.
• Influence development of improved and streamlined quality systems.
• Provide technical support and expertise for site and Corporate on analytical topics.
• Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility issues.
• Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure customer needs are met
• Network with other sites regarding new systems development and best practices for analytical processes
• Develop plan for capital purchases
• To approve or reject, as they see fit, starting materials, packaging materials, intermediate, bulk, and finished products.
• To ensure that all necessary testing is carried out and the associated records evaluated.
• To approve specifications, sampling instructions, test methods, and other Quality Control procedures.
• To approve and monitor any contract analysts.
• To ensure the qualification and maintenance of their department, premises, and equipment.
• To ensure that the appropriate validations are done.
• To ensure that the required initial and continuing training of their department personnel is carried out and adapted according to need.
• To ensure adequate design, effective implementation, monitoring, and maintenance of the quality management system.
• The authorization of written procedures and other documents, including amendments.
• The monitoring and control of the manufacturing environment.
• Plant hygiene.
• Process validation.
• Training.
• The approval and monitoring of suppliers of materials.
• The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities.
• The designation and monitoring of storage conditions for materials and products.
• The retention of records.
• The monitoring of compliance with the requirements of Good Manufacturing Practice.
• The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
• Participation in management reviews of process performance, product quality, and of the quality management system and advocating continual improvement
• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.

Benefits

• eligible for a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees