Quality Manager/Pharmaceuticals

Mykelly; Indianapolis (IN); Presencial; USD 120.000 - 140.000; Jornada completa

Descripción de la vacante

Mykelly is seeking an experienced Quality Manager to lead quality operations just north of Indianapolis, IN. You will interface with client quality counterparts, foster a robust quality culture, and serve as the primary regulatory liaison for pharmaceutical distribution operations.

The role oversees quality personnel, tracks performance metrics, and ensures strict GxP compliance with client standards. Day shift, direct hire/exempt, target salary $120–$140K.

Formación

• Bachelor of Science degree with 8–10 years of relevant experience, OR a Master’s degree with experience managing a large team.
• Location preference for local candidates; relocation upfront discussions encouraged.

Responsabilidades

• Develop a strong quality culture, policies, and QA processes in collaboration with clients.
• Interpret and apply GxP regulations; manage audits, inspections, and quality projects.
• Lead projects with GxP compliance implications and communicate regulatory changes.
• Partner with Operations to allocate resources and ensure ongoing quality program management.
• Coach and mentor teams to improve quality and drive measurable improvements.

Conocimientos

Quality Leadership

Regulatory Compliance

Operations Management

Risk Management

Coaching & Training

Educación

Bachelor of Science

Master’s Degree

Descripción del empleo

Quality Manager/Logistics

Location: Indianapolis, Indiana area
Specialty: Pharmaceutical Logistics
Job Status: Direct Hire/Exempt
Target Salary: $120-140K
Shift: Day Shift

We are seeking an experienced Quality Manager to lead our quality operations located north of Indianapolis, IN facility. In this role, you will interface directly with client quality counterparts, drive a robust culture of quality, establish policies and procedures, and serve as the primary regulatory liaison for pharmaceutical distribution operations. You will oversee quality personnel, manage performance metrics, and ensure strict compliance with GxP regulations and client standards.

Key Responsibilities

Quality Leadership & Culture

• Drive the development of a strong quality culture, strategy, policies, warehouse team objectives, and overall Quality Assurance processes in collaboration with clients.
• Champions in a quality environment that optimizes employee productivity, participation, and value addition.
• Act as a coach, mentor, and trainer to instill a passion for quality across the organization.

Regulatory & Compliance Management

• Interpret and apply applicable GxP regulations and policies to unique and complex operational issues.
• Manage internal and external audits/assessments (routine and non-routine), regulatory inspections, and quality projects.
• Lead all projects, programs, and team development activities with GxP compliance implications.
• Proactively identify, communicate, and monitor business and regulatory changes impacting warehouse operations.
• Act as the regulatory agency liaison on behalf of the company.

Operations & Risk Management

• Partner with Operations Management to allocate resources, manage priorities, schedules, and projects to achieve quality objectives.
• Direct reports and lead matrix teams or business processes to ensure effective quality program management.
• Engage in proactive risk management, identifying effective strategies, escalating risks, and implementing solutions.
• Provide actionable recommendations and solutions that demonstrate measurable quality improvement and value for internal and external customers.
• Represent the client in strategic and operational business decisions.
• Develop the skills and knowledge base of the warehouse operations team to ensure ongoing compliance with evolving regulations and client expectations.

Site Details

• Operations: Handles ambient, dangerous goods, sterile injectables, APIs, excipients, and temperature-controlled materials.

Qualifications & Requirements

• Education & Experience: Bachelor of Science (BS) degree with 8–10 years of relevant experience, OR a Master’s degree with experience managing a large team.
• Location Preference: Preference given to local candidates; relocation will be considered (candidates must share relocation requirements upfront).