Pharma QA Manager: Audits, Compliance & Leadership

Tower Laboratories, Ltd.; Montague Township (MI); Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Medical insurance

HSA option

Dental insurance

Vision insurance

Accident, critical illness, and life保险

Voluntary life insurance

Company-paid life insurance

Long-term disability

401(k) with employer contribution up

Paid time off, sick time, and 9 paid <

Zusammenfassung

Tower Laboratories, Ltd. is seeking an experienced Quality Assurance Leader to oversee QA auditing in the Montague facility and align QA activities with Tower Labs’ business objectives.

The role includes supervising auditors, conducting inspections, supporting manufacturing, and maintaining proper documentation. Responsibilities include leading audits, reviewing packaging and BOMs, investigating root causes, and ensuring cGMP compliance and timely communication with stakeholders.

Qualifikationen

• Five years experience in Quality Assurance leadership in the pharmaceutical industry.
• Demonstrated current knowledge of cGMP regulations and industry standards.
• Ability to train others and provide guidance.
• Strong team player, demonstrated team attitude and behaviors.
• Working knowledge of MS Word and MS Excel.
• Strong writing skills.
• Excellent organizational skills; ability to delegate.
• Strong attention to detail.
• Strong problem-solving and analytical skills.

Aufgaben

• Oversee daily activities of QA Auditor(s); provide direction and training as needed.
• Ensure compliance with FDA rules and cGMP processes.
• Conduct packaging audits to ensure final product meets specifications and AQL.
• Lead investigations and determine root causes when issues occur.
• Perform internal GMP audits and maintain compliance with procedures.
• Participate in onsite audits as needed.
• Audit finished batch production documents and release of finished product.
• Communicate deficiencies to key personnel and work with cross-functional teams to resolve issues.

Kenntnisse

QA Leadership

cGMP knowledge

Training others

Team player

MS Word

MS Excel

Writing skills

Organization

Problem-solving

Ausbildung

Bachelor’s degree in Science

Equivalent QA experience

Jobbeschreibung

Tower Laboratories, Ltd. is seeking an experienced Quality Assurance Leader to oversee QA auditing in the Montague facility and align QA activities with Tower Labs’ business objectives.

The role includes supervising auditors, conducting inspections, supporting manufacturing, and maintaining proper documentation. Responsibilities include leading audits, reviewing packaging and BOMs, investigating root causes, and ensuring cGMP compliance and timely communication with stakeholders.