Eli Lilly

Site Compliance Leader

Eli Lilly • $123K — $180K *
Houston, TX 77084In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's, Master's, or PhD in Pharmacy, Science, Engineering, Quality, or a related field.
  • Minimum of 12 years of experience in quality assurance in biotech or pharmaceutical sectors.

Responsibilities

  • Establish and document processes for the Houston quality management system.
  • Monitor and report on the quality management system's effectiveness and needed improvements.
  • Raise awareness of regulatory and quality management system requirements across the organization.
  • Collaborate with central groups on corporate quality standards and initiatives.
  • Lead site initiatives for quality and compliance, ensuring local execution of global initiatives.
  • Create and manage the Site Quality Plan and Site Quality Manual.
  • Direct site-wide quality governance boards and ensure quality oversight for processes and materials.
  • Coordinate regulatory inspections and manage the site's readiness program.

Benefits

  • Eligible for a company bonus based on performance.
  • Comprehensive medical, dental, vision, and prescription drug benefits.
  • 401(k) and pension plan participation.
  • Flexible benefits including health and dependent care spending accounts.
  • Employee assistance programs and wellness support, including fitness benefits and social activities.
Full Job Description
The Site Compliance Leader plays a critical role in managing compliance to all regulatory requirements in line with Lilly Houston procedures, policies and guidelines for next generation biotech facilities. You will work closely with cross-functional teams by having oversight of central quality systems and processes. Provide quality and technical expertise within the quality department of Lilly Houston.

Key Responsibilities
• Ensure that processes needed for the Houston quality management system are established and documented.
• Monitor and report on the effectiveness of the quality management system and needed improvements.
• Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
• Liaise with and influence central groups on corporate quality standards and initiatives.
• Sponsors site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation; acts as connection for global initiatives related to quality and compliance for local implementation.
• Ensure creation and manage Site Quality Plan and Site Quality Manual and ensure adequate governance of key quality processes at the site (e.g., site quality lead team, management reviews of quality systems, etc.).
• Provide direction for the site-wide quality governance boards (e.g., site quality lead team, deviation review board, change control review board, etc.)
• Ensure adequate quality oversight for material and supplier management, incoming controls, complaints, etc.
• Lead and model behaviors foundational to strong quality culture.
• Coordinate and manage regulatory inspections and lead the site inspection readiness program.
• Acts as liaison with Regulatory for Site Licenses and declarations, Site Master file, and other Regulatory Compliance related documents.
Benchmark with external sources to understand industry trends and share with internal quality organizations.

Educational Qualifications and Experience Requirements
  • BSc, Hons BSc, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
  • Minimum of 12+ years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.


Additional Skills & Preferences
• Demonstrated capability to effectively prioritize tasks and responsibilities
• Ability to work independently
• Excellent communication skills, both written and verbal, allowing for clear and concise expression of ideas, instructions, and feedback.
• Effective decision-making
• Exceptional ability to build and maintain positive relationships with colleagues, clients, and stakeholders
• Fundamental knowledge of computer applications
• Strong problem-solving skills
• Experienced in creating clear and comprehensive procedures and training materials
• Proven ability to mentor and lead others, providing guidance, support, and motivation to help them achieve their goals.
Strong follow-up skills, ensuring that tasks and projects are completed on time and to the required standard. This involves tracking progress, addressing any issues that arise, and maintaining clear and consistent communication with all relevant parties.

Additional Skills & Requirements
  • Proficient in English.
  • Travel 20%.
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$123,000 - $180,400

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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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