On-Site Senior Lab Quality Operations Leader

Alcami Corporation; Morrisville (NC); On-site; USD 100,000 - 140,000; Full time

Job summary

Alcami Corporation in Morrisville is seeking an Associate Director for Laboratory Quality Operations. This role involves ensuring compliance with FDA regulations, overseeing QMS, and providing leadership and direction to the quality team. Candidates should possess significant experience in pharmaceutical quality and strong leadership abilities.

The position promises a dynamic work environment with responsibilities including regulatory audits and direct interactions with clients, requiring exceptional problem-solving skills.

Qualifications

• 10+ years of pharmaceutical quality experience required.
• 7+ years of management experience required.
• Prior pharmaceutical experience required; prior CDMO experience preferred.

Responsibilities

• Responsible for compliance of laboratory operations within established SOPs and regulations.
• Oversees QMS to ensure timely closure of deviations and investigations.
• Guides management in compliance issues and leads regulatory inspections.

Skills

Pharmaceutical regulatory knowledge

Leadership skills

Critical thinking

Coaching and mentoring

Strategic planning

Education

Bachelor’s degree (Chemistry, Biology, Microbiology)

Master’s degree

Job description

Alcami Corporation in Morrisville is seeking an Associate Director for Laboratory Quality Operations. This role involves ensuring compliance with FDA regulations, overseeing QMS, and providing leadership and direction to the quality team. Candidates should possess significant experience in pharmaceutical quality and strong leadership abilities.

The position promises a dynamic work environment with responsibilities including regulatory audits and direct interactions with clients, requiring exceptional problem-solving skills.