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Associate Director - QA - Lebanon APIInitial Therapeutics, Inc. • Lebanon, Pennsylvania, United States
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Associate Director - QA - Lebanon API

Initial Therapeutics, Inc.
  • US
    Lebanon, Pennsylvania, United States
  • US
    Lebanon, Pennsylvania, United States
Apply Now

About

Job Position Overview The Quality Assurance Associate Director provides quality oversight to the API manufacturing processes. The Associate Director is responsible for managing the development of direct reports and prioritizing work to implement LP1 and QA objectives. This position will focus on the oversight of operational readiness and initiation of production within the synthetic peptide facilities. The role has responsibility to oversee the team's performance, resolve quality issues and ensure compliance.
Responsibilities
Provide direct quality oversight to LP1 manufacturing and assist others in interpreting regulatory and corporate requirements.
Provide quality guidance, technical support and recommendations for equipment and process issues and continuous improvement initiatives. Lead resolution of quality issues.
Work with cross‑functional teams to implement QA objectives.
Prepare for and participate in internal and external regulatory inspections. Lead the QA team in maintaining and improving site quality systems, ensuring alignment with global quality standards and external regulations.
Guide and coach QA manufacturing staff, including performance management and career development.
Mentor QA manufacturing representatives in aspects of QA support including process understanding, problem solving, project management and deviation investigation/resolution.
Basic Requirements
BS in Engineering or science related field.
5+ years in cGMP manufacturing.
Additional Skills/Preferences
Previous leadership experience in pharmaceutical industry.
Prior experience with synthetic peptide manufacturing in QA, TS/MS, QC or Engineering.
Demonstrated problem solving and decision making skills.
Strong written and verbal communication skills with strong attention to detail.
Strong technical aptitude, analytical thinking skills and ability to train and mentor others.
Prior work with cGMPs or external regulations.
Experience with root cause investigations.
Strong knowledge of Quality Management Systems and applicable regulatory requirements.
Compensation & Benefits 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 are also eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; 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.
Equal Opportunity Employer 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.
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  • Lebanon, Pennsylvania, United States

Languages

  • English
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