Job Details

Job Summary

Quality Systems Sr. Manager at Alcami Corporation is accountable for driving results in a fast‑paced environment, continuously challenging performance in regard to quality standards, systems, and operating procedures. The role provides technical oversight of investigations and quality systems, ensuring compliance with applicable regulatory requirements and company procedures. The Manager performs document and protocol approvals, CAPAs, change control, audit support, trend analysis, and quality training. SOPs and other quality documents are developed as needed.

Responsibilities

• Ensure GMP compliance with regulatory requirements and company procedures (21 CFR Parts 4, 210, and 211).
• Review and approve complex documents, data, audit responses, investigations, change controls, protocols, and reports.
• Collaborate with site Operations and Technical leadership to close deviations, non‑conformance investigations, and corrective actions.
• Support client and regulatory agency audits and inspections to minimize observations.
• Assist in generating on‑time site responses to regulatory and client audit reports.
• Maintain and approve quality system documentation.
• Perform trend analysis and data review where required.
• Coordinate and maintain the Quality Council / Management Review.
• Guide, instruct, and coach team members on quality and compliance issues.
• Participate in quality improvement initiatives.
• Develop quality SOPs and related reports.
• Implement systems that enhance efficiency and compliance at the site.
• Provide consultation on complex quality and compliance topics.
• Deliver training on quality and compliance topics.
• Provide oversight over the site's Quality Management Systems, including investigations, CAPA, change control, etc.
• Ensure accurate file and record maintenance.
• Complete cGMP and company training requirements on time.
• Perform duties as assigned.

Qualifications

• Bachelor's degree in Chemistry, Biology, or a related field and 10+ years of related experience, or Master's degree in a relevant field and 8+ years of related experience.
• Relevant GMP experience required.
• Experience in environmental monitoring and critical utilities preferred for sterile operations.

Knowledge, Skills, and Abilities

• Expert knowledge of pharmaceutical regulatory requirements and cGMP.
• Knowledge of quality systems, change control, CAPA, and data integrity.
• Knowledge of aseptic processing of commercial or clinical parenteral products.
• Knowledge of auditing preferred.
• Excellent leadership, coaching, and influencing skills.
• Strong analytical and problem‑solving abilities.
• Excellent written and oral communication and presentation skills.
• Strong business acumen and understanding of SOPs and regulatory guidance.
• Attention to detail and effective time and resource management.
• Good presentation skills and professional integrity.
• Ability to work independently with minimal direction.
• Capability to communicate effectively with internal customers, team members, and external stakeholders.
• Strong work ethics and commitment to company policies.

Travel Expectations

• Up to 5% travel required.

Physical Demands and Work Environment

The role requires regular use of hands, fingers, and arms. Employees must be able to stand, walk, sit, and occasionally lift up to 50 pounds. The work environment may involve exposure to mechanical parts, vibration, and varying noise levels. Appropriate personal protective equipment (PPE) such as safety eyewear, respirators, lab coats, and gloves may be required. Reasonable accommodation will be provided for qualified individuals with disabilities.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Quality Assurance