Associate- Director Quality - Site Expansion US, Indianapolis IN

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$118,500 - $173,800

Organization Overview:
The Associate Director of Quality Assurance will manage quality oversight for systems, equipment, utilities, facilities, processes, and resource evaluation within the IDAP Expansion Team. Responsibilities include providing input on quality and data requirements, coordinating resources, and staying updated on new technologies. The role involves setting strategies and objectives to ensure compliance with cGMPs, global standards, and site quality requirements. The Associate Director will lead a team of quality engineers, technicians, or associates, serve as the key contact for inspections, and maintain inspection readiness

Key Objectives/Deliverables:

People:

• Actively expand knowledge of technology, applicable regulations through external trainings, reading magazines, among others.

• Coaches, mentors, and enables knowledge transfer to direct reports, identified associates, peers, and leaders.

• Manage resource loading of IDAP technical resources across various projects within team scope, and support additional sites projects as capacity allows.

Quality System: Ensure compliance with cGMPs and quality corporate policies with special attention to the following:

• Validation / Qualification: Participate in defining strategies and policies of validation / qualifications requirements.  In addition, to ensure the implementation and execution with the established commitments for ensuring compliance with good manufacturing practices (GMP) or GxP.

• Change Control: Evaluate and approve the impact of proposed changes in the light of validated processes, regulations, and regulatory commitments.

• Deviations: Evaluate, assess, and approve the impact of deviations in the light of validated processes and regulations to ensure that the quality of the product is not affected.  Ensuring the effective of corrective actions associated with action plans cover the root cause of the situation to eliminate them and has been evaluated with a holistic approach.

• Standard Operation Procedure (SOPs): Ensure that appropriate procedures are available to cover all activities related to Good Manufacturing Practices (GMPs / GxPs).  Ensure staff affected have been properly trained in the content of the SOPs.

• Documentation: If required, write, publish and present regulatory changes and technical reports.  Ensure compliance with records retention requirements and properly maintain them.

• Quality Plan: Ensure action plans meet requirements, drive continual improvement, and meet with the date established.

Organization:

• Maintain the independence of the quality assurance issues and quality decisions, including management of QA resources.

• Manage or assist with the department budget, participate in organizational planning, and development of business plan for area of responsibility.

• Aid in human resource development, planning, and performance management for direct reports.

Functional Responsibilities:

• Lead and actively participate in Quality lead team, applicable functional lead teams, and global / network governance meetings.

• Participate actively in the implementation of safety, quality, and lean initiatives.

• Understand processes under current responsibility ensuring knowledge of critical parameters, risk assessments, and area performance.

• Advance and align data integrity, technology enhancements, system upgrades, and process flows with global and network expectations.

• Drive the required performance established from stakeholders, suppliers, peers, and direct reports.

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.

Management of Controlled Substances, if applicable:

• Comply with all established requirements to receive and maintain authorization to handle controlled substances.

  • Successfully complete the background check process.

  • Complete the training assigned to your learning plan within the established due dates.

  • Report drug diversion.

    • Any employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer, as established in the Code of Federal Regulations
      CFR 1301.91.

• Report illicit activities by employees:

• You are responsible under state, federal and local law, and Lilly policy to report to your supervision and Global Security any irregular or unauthorized employee activities involving controlled substances / drugs (e.g., unauthorized or illicit possession, manufacture, use, distribution, theft, diversion, or destructions), as established in the Code of Federal Regulations 21 CFR 1301.92

Basic Requirements:

• Education: Bachelor’s Degree in Engineering, or related field.

• Experience: 5+ years of demonstrated relevant experience in a pharmaceutical / medical device industry.

• Skills:

  • Knowledge with 21 CFR Part 210, 211, and 820 and other major regulations that govern pharmaceutical and medical device manufacturing and packaging.

  • Experience with deviation management, change control management, and production practices for dry product and device assembly packaging.

  • Proficiency with computer systems including Microsoft Office products.

  • Demonstrate strong oral and written communication and interpersonal skills.

  • Demonstrated ability to find solutions and alternatives through teamwork embracing diversity, equity, and inclusion resulting in positive business outcomes.

  • Experience with being a mentor, coach, and/or giving and receiving feedback.

Additional Skills/Preferences:

• Previous supervisory/leadership experience

• Device assembly or Packaging Experience

• Experience in project management or certified six sigma green or black belts is a plus

Additional Information:

• Travel may be > 10%.

• On-site support is required and follows the work from home global manufacturing and quality policies.

• Overtime and responding operational or site support outside of core business hours and days is required.

• Applicant will work in various areas within the IDAP Plant.  Some allergens are present in IDAP.  Mobility requirements and exposure to allergens should be considered when applying for this position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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