SR MANAGER QUALITY (4797)

POSITION PURPOSE

ESSENTIAL FUNCTIONS AND BASIC DUTIES

QUALITY SYSTEM LEADERSHIP 

• Ensure effective execution of CAPA, deviations, change control, complaint handling, internal auditing, and all other QMS activities. 
• Drive root cause analysis rigor and sustainable corrective actions. 
• Develop and drive action plans to achieve QA Metrics and address adverse trends.
• Provide and present data on key QA Metrics.

AUDIT AND INSPECTION READINESS

• Lead readiness for FDA, Customer, and Third-Party Quality audits.
• Lead routine customer meetings to align on Quality activities across the site.

CONTRACT MANUFACTURING COMPLIANCE

• Serve as internal quality compliance lead for contract manufacturers and external manufacturing partners.
• Support quality agreements, external audits, and follow‑up actions.
• Trend compliance performance and escalate risks.

TEAM LEADERSHIP

• Manage QA, QC, and Quality Engineering performance and development.
• Establish a cross-functional Quality Culture built on respect for people, compliance, continuous improvement, and accountability.

PERFORMANCE MEASUREMENTS

• Audit Performance
• Delivery of KPI’s
• Team Performance

The above responsibilities are intended to describe the general content of and requirements for the performance of this position. It is not to be construed as an exhaustive list or statement of duties, responsibilities or requirements.

EDUCATION/CERTIFICATION:

B.S. or B.A. degree in an appropriate subject matter.

REQUIRED KNOWLEDGE:

Proficiency in Microsoft Office Suite, Internet Browsers, and Adobe PDF applications. Familiarity with electronic QMS programs like SAP, Master Control, Intell Aquest, Spec right, etc.   

EXPERIENCE REQUIRED:

• 5+ years in a regulated industry, Cosmetic and Pharmaceutical preferred
• Experience with direct customer communication and technical certificates are a plus.

SKILLS/ABILITIES:

• Ability to prioritize daily workload, multitask, and shift scope to meet business needs.
• Ability to work independently, cross-functionally, and within a team environment.
• Strong attention to detail, excellent analytical and critical thinking skills
• Possesses strong written and verbal communication skills
• Ability to troubleshoot documentation and technical issues with minimal guidance.
• Ability to participate effectively in audits and inspections

WORKING CONDITIONS

NONE:

Normally exposed to typical office environment.  Occasionally, worker exposed to: Extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort, sufficient noise to cause worker to shout to be heard above the ambient noise level, and hazards such as proximity to moving mechanical parts.