Job description

Manager, Quality Assurance
Up to $150,000 with relocation

Our client is a global leader in Aseptic Manufacturing within pharmaceuticals and has over 40 years of experience.

They are looking for a Quality Systems Manager who will be responsible for managing personnel maintaining CAPA, Document Review, Technical Services, and Document Control. In addition, this individual is responsible for scheduling and leading domestic and international audits

Location:
Grand Rapids, MI

Qualifications:

• Bachelor’s degree in Life Sciences or a related field and/or a minimum of 5+ years related work experience.
• 5-10+ years in technical, quality, or continuous improvement role in a manufacturing or pharmaceutical industry.
• Knowledge of Process Improvement methodologies (e.g. Lean, Six Sigma).
• Knowledgeable user of Root Cause Analysis tools (5 Why, Fishbone, etc.).
• Prior experience teaching, coaching, or facilitating Root Cause Analysis investigations.
• Prior experience leading cross-functional teams across all levels of the organization.
• Prior experience using MasterControl or other electronic quality systems such as Track Wise, SAP, etc.
• Knowledge of Manufacturing and QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment

Responsibilities:

• Provide leadership to Quality Assurance Specialists including hiring, motivating, coaching, and mentoring.
• Direct responsibility and oversight of the NCR, CAPA, and Change Management processes. Provide leadership to QA Specialists who act as facilitators for cross-functional teams responsible for performing Root Cause Analysis investigations and corrective/preventative action plans.
• Work cross-functionally to ensure NCRs are initiated, investigated, and are closed on time with appropriate and effective CAPAs assigned.
• Responsible for providing identified process trends and KPI Metrics for monthly QMR.
• Monitor the process performance of the NCR, CAPA, and Change Management processes using metrics and routine trending to identify continuous improvement initiatives that will result in a more effective, efficient, and/or complaint process.
• Provide NCR, CAPA, and skills-based problem-solving training (RCA, DMAIC, Critical Thinking, etc.) to end-users based on their applicable job role.
• Support and interface with auditors, including client representatives and regulatory agencies related to the NCR, CAPA, and Change Management processes.

Job Type: Full-time

Salary: $110,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Grand Rapids, MI: Reliably commute or willing to relocate with an employer-provided relocation package (Preferred)

Experience:

• FDA regulations: 5 years (Preferred)
• CAPA: 4 years (Preferred)
• Quality management: 5 years (Required)

Work Location: One location

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