Sr. Director - API Manufacturing Quality Assurance

Initial Therapeutics, Inc.; Huntsville (AL); On-site; USD 156,000 - 228,800; Full time

Benefits offered by this job

401(k)

Pension

Medical benefits

Vacation benefits

Well-being benefits

Job summary

Initial Therapeutics, Inc. is seeking a Sr. Director – QA for its new API manufacturing facility in Huntsville, Alabama. This role will oversee all quality and compliance systems, ensuring that production meets cGMP standards.

The ideal candidate has 10+ years in pharmaceutical quality, including 5 years of leadership experience. This position offers a salary range of $156,000 to $228,800, alongside a benefits package that includes a 401(k), medical, dental, and well-being programs.

Qualifications

• 10+ years of pharmaceutical manufacturing quality experience.
• 5+ years of supervision/leadership experience.

Responsibilities

• Serve as Site Quality Leader on the Lilly Site Lead Team.
• Ensure site-wide compliance with cGMPs, procedures, and standards.
• Lead the API Quality Team and manage its agenda.
• Develop and monitor a site Quality Plan and metrics.
• Coordinate and manage regulatory inspections.

Skills

Pharmaceutical manufacturing quality experience

Supervision/leadership experience

Statistical analysis

Strong interpersonal and communication skills

Problem-solving and analytical thinking

Education

Bachelor's degree (STEM degree preferred)

Job description

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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Position Overview

The Sr. Director – QA serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. This role ensures the strength and continuous improvement of all quality and compliance systems, activities, and personnel. Additionally, the Sr. Director – QA is responsible for maintaining utilities and ensuring that raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements.

Key Responsibilities

• Serve as Site Quality Leader on the Lilly Site Lead Team.

• Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments.

• Lead the API Quality Team and manage its agenda.

• Support quality forums (e.g., Deviation and Change Control Boards).

• Develop and monitor a site Quality Plan and metrics.

• Coordinate and manage regulatory inspections.

• Review and approve manufacturing and quality system documents.

• Ensure adequate QA staffing and provide coaching and development.

• Use HR tools for performance management, staffing, and succession planning.

• Contribute to QA business planning and site-wide strategic planning.

Basic Requirements

• Bachelor's degree (STEM degree preferred)

• 10+ years of pharmaceutical manufacturing quality experience

• 5+ years of supervision/leadership experience

Additional Preferences

• Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs

• Proficient in statistical analysis and computer applications

• Strong interpersonal, communication, and networking skills

• Ability to influence diverse teams and manage multiple priorities

• Demonstrated problem-solving and analytical thinking

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

$156,000 - $228,800

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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