Quality Manager

Harba Solutions Limited; Indianapolis (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

A life sciences solutions provider is seeking a Quality Operations Manager in Indianapolis, Indiana. The ideal candidate will have a Bachelor's degree in a relevant field and 7-10 years of experience in a GMP-regulated environment. Responsibilities include leading quality functions in warehouse and distribution operations, managing audits and regulatory inspections, and developing the quality team. Strong knowledge of GMP and leadership skills are essential. A positive culture and commitment to quality are paramount in this role.

Qualifications

• 7-10 years of experience in Quality Operations within a GMP-regulated environment.
• Experience leading audits, inspections, and regulatory interactions.
• Strong working knowledge of GMP, GDP, and Good Documentation Practices.

Responsibilities

• Lead the quality function for life sciences warehouse and distribution operations.
• Drive and maintain a strong GxP-compliant quality culture aligned with client expectations.
• Interpret and apply GMP/GDP regulations to routine and complex operational issues.
• Manage, coach, and develop Quality team members.
• Monitor, analyze, and report quality performance metrics.

Skills

Leadership

Analytical skills

Communication skills

Organizational skills

GMP knowledge

Cross-functional collaboration

Bilingual (Spanish)

Education

Bachelor’s degree in Chemistry, Biology, Biochemistry, or related STEM field

Job description

Job Requirements

• Lead the quality function for life sciences warehouse and distribution operations.

• Serve as the primary authority for quality-related decisions impacting processes, policies, and procedures.

• Drive and maintain a strong GxP-compliant quality culture aligned with client expectations.

• Interpret and apply GMP/GDP regulations to routine and complex operational issues.

• Lead internal and external audits, regulatory inspections, and quality assessments.

• Partner with Operations leadership to manage resources, priorities, and quality objectives.

• Oversee quality projects, continuous improvement initiatives, and risk management activities.

• Manage, coach, and develop Quality team members.

• Act as the primary quality point of contact for clients, auditors, and regulatory agencies.

• Monitor, analyze, and report quality performance metrics; identify improvement opportunities.

• Manage investigations, CAPAs, training programs, and client quality requests.

Job Qualifications

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or related STEM field preferred.

• 7–10 years of experience in Quality Operations within a GMP-regulated environment.

• Strong working knowledge of GMP, GDP, and Good Documentation Practices.

• Experience leading audits, inspections, and regulatory interactions.

• Proven leadership and team development experience.

• Strong analytical, organizational, and communication skills.

• Ability to work cross-functionally in an operations-focused environment.

• Spanish language proficiency is a plus.

• Ability to work in warehouse environments with temperature variation and lift up to 50 pounds.