Quality Operations Executive: cGMP & Compliance Leader

Alternative Resources Company, an Openwork Company; North Carolina; On-site; USD 180,000 - 190,000; Full time

Job summary

Alternative Resources Company, an Openwork Company, seeks a senior quality leader to guide QA and regulatory affairs in a pharmaceutical manufacturing environment. You will set strategic direction for Quality Assurance, Quality System, and Quality Control, mentoring staff and directing audits and inspections.

Key responsibilities include overseeing analytical and microbiology labs, ensuring cGMP compliance, and coordinating regulatory interactions with FDA.

Qualifications

• 15+ years pharmaceutical quality experience in manufacturing, CMO, or life sciences tech.
• Analytical and microbiology proficiency for semi-solid drug products.
• Extensive experience with cGMP and regulatory compliance requirements.
• Proven leadership of quality and analytical teams and strategic growth initiatives.
• Experience across the product development lifecycle from concept to validation.
• Ability to lead, influence and work in cross-functional teams.

Responsibilities

• Provide leadership and direction to the Quality organization.
• Mentor, oversight and development for QA, Quality System, QA staff.
• Make decisions on key quality-related strategic and operational matters.
• Direct and control activities and outcomes of Quality Assurance.
• Set and align goals for QA with corporate objectives.
• Oversee regulatory inspections with FDA or other agencies.
• Develop and maintain external relationships with key officials.
• Direct development of systems to review design/manufacturing changes.
• Provide leadership for significant deviation events affecting compliance or risk.
• Oversee laboratories (analytical/microbiology), release testing, stability, environmental monitoring.
• Review and approve quality documents (deviations, OPRs, complaints, validation, change controls).

Skills

Quality Leadership

Regulatory Compliance

Cross-functional Leadership

Strategic Planning

FDA/Regulatory Inspections

Analytical & Microbiology

Education

Bachelor’s Degree or higher in life sciences, engineering, or business

Job description

Alternative Resources Company, an Openwork Company, seeks a senior quality leader to guide QA and regulatory affairs in a pharmaceutical manufacturing environment. You will set strategic direction for Quality Assurance, Quality System, and Quality Control, mentoring staff and directing audits and inspections.

Key responsibilities include overseeing analytical and microbiology labs, ensuring cGMP compliance, and coordinating regulatory interactions with FDA.