Sr. Manager - QA Assurance

BioSpace; Durham (NC); On-site; USD 94,500 - 138,600; Full time

Benefits offered by this job

401(k) and pension plans

Comprehensive medical benefits

Annual performance bonus

Job summary

A global healthcare leader is seeking a Senior Manager, Quality Assurance in Durham, NC. This role involves leading a QA organization to ensure compliance with regulatory standards and manage quality processes in manufacturing. The ideal candidate has significant experience in Quality Assurance and leadership skills. The expected salary ranges from $94,500 to $138,600, and the position entails a day-shift schedule. Strong technical expertise and interpersonal skills are crucial for success in this role.

Qualifications

• 5+ years of experience in Quality Assurance, with at least 3 years in a leadership role.
• Demonstrated strong experience with pharmaceutical manufacturing and regulations.
• Ability to train and mentor others.

Responsibilities

• Build and manage a QA organization for operational excellence.
• Lead and coach QA teams on safety and quality.
• Oversee quality processes and compliance documentation.

Skills

Leadership in QA

Technical knowledge in Quality Management Systems

Interpersonal communication

Problem-solving

Attention to detail

Education

Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field

Tools

Manufacturing Execution Systems

Trackwise

Veeva

MODA

Job description

Overview

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 worldwide work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back 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.

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for an experienced Quality Assurance Manager to support our growth in the Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

Position Description

Senior Manager, Quality Assurance is responsible for providing leadership and technical oversight for the formulation, filling, and visual inspection areas to ensure compliance with regulatory requirements, corporate standards, and industry best practices. This role combines people management with technical quality expertise, driving team structuring, collaborators development, continuous improvement of regulated processes, documentation, and operational readiness. The Senior Manager will help build a strong quality culture, lead inspection readiness, and provide ongoing operational support.

Responsibilities

• Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence.
• Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement.
• Establish and monitor performance objectives, providing feedback and coaching to drive team development.
• Identify business and quality risks, escalating appropriately and in a timely manner.

Technical Responsibilities

• Provide continuous quality improvement oversight to regulated processes, practices, and documentation.
• Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements.
• Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues.
• Work cross-functionally with process teams for metrics reviews, operational support, and deviation management.
• Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance.
• Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings.
• Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines.
• Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes.
• Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions.

Minimum Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field.
• 5+ years of experience in Quality Assurance, with at least 3 years in a leadership role.
• Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements.
• Demonstrated attention to detail and ability to maintain quality systems.
• Previous experience leading or working effectively with a cross-functional group.
• Demonstrated excellent interpersonal, written and oral communication skills.
• Demonstrated strong technical aptitude and ability to train and mentor others.
• Demonstrated decision making and problem-solving skills.
• Demonstrated ability to organize and prioritize multiple tasks.

Additional Preferences

• Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• CQM, CQE, or CQA certification from the American Society for Quality (ASQ).
• Previous experience with Trackwise, Veeva, MODA.

Additional Information

• The schedule for this position is 12 hours day-shift (2-2-3).

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $94,500 - $138,600. 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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