QA Manager

Evonik•Lafayette, IN

11d•Hybrid

About The Position

This position requires a broad experience in working in a GMP environment and fast changing environment. The QA Manager demonstrates exceptional leadership with the ability to set and drive direction of a highly diverse team. This position requires the abilityto work in a cross functional leadership team and provide direction with respect to GMP compliance and business efficiency. This person requires the ability to assess the work of the team and set goals and priorities accordingly to ensure that work is completed in a compliant and most efficient manner.

Requirements

BS in chemistry, engineering, science, or equivalent experience.
8+ years industrial experience in a GMP environment preferred.
Extensive GMP compliance knowledge for products such as APIs, Food Additives, Excipients.
Ability to apply compliance standards to production.
Strong communication and leadership skills.
Ability to work in undefined environments.
Must provide 24/7 coverage as needed.

Responsibilities

Ensure production areas receive the resources and QA support needed to maintain GMP compliance while meeting batch release timelines.
Lead performance planning, goal accountability, and development for all direct reports, providing consistent coaching and mentoring.
Foster collaboration between QA Project Managers and Production QA Representatives to support product transfers that meet customer expectations and regulatory requirements.
Build and maintain a qualified QA production support team through strategic staffing, training, and organizational development.
Drive continual improvement of the Site Quality Management System in alignment with cGMP standards (ICH Q7, ISO 9001, Food GMP) and corporate Health Care quality systems.
Ensure compliance with all internal, customer, and regulatory quality commitments while supporting internal/external audits and authority inspections.
Maintain and report key KPIs, lead departmental improvement initiatives—especially those focused on efficiency and digitalization—and stay current on GMP trends.
Oversee development of GMP paper/electronic data systems and provide delegated backup support for the Quality Assurance Director.