Associate Director, Quality Assurance

Merck KGaA Darmstadt Germany - Wilson, NC

Full-time - Mid Level

Onsite - Wilson, NC

Chemical Manufacturing

About the position

The Associate Director of Quality Assurance is responsible for overseeing quality assurance functions within the manufacturing operations, ensuring compliance with regulatory standards and internal processes. This role involves managing a team, conducting audits, and ensuring the quality of products from raw materials to finished goods, all while fostering a culture of safety and continuous improvement.

Responsibilities

• Oversee quality assurance functions for plant-wide systems and processes.
• Conduct batch record review and release, bulk and component review and release.
• Manage retention, investigations, and defect resolution processes.
• Ensure proper implementation and documentation of audits, regulatory document reviews, and SOPs.
• Control and approve the final release of finished goods from the site.
• Provide final approval of packaging investigations and release decisions for materials.
• Interview, hire, and train personnel, ensuring compliance with company policies.

Requirements

• Bachelor's degree in Science or Engineering.
• Minimum of six years of experience in the pharmaceutical industry, preferably in Quality Assurance.
• Ability to provide technical direction and training in Good Manufacturing Practice and safety practices.
• Expertise in Quality Assurance and ability to improve products and processes based on internal/external challenges.
• Strong organizational and time management skills.
• Ability to work independently with minimal guidance.

Nice-to-haves

• Thorough knowledge of plant-wide systems and processes.
• At least two years of supervisory experience.

Benefits

• Hybrid work model with three days on-site and two days remote per week for eligible positions.
• Relocation assistance for domestic and international moves.
• Visa sponsorship available for qualified candidates.