Associate Quality Director - Med Dev / Pharma

Quality Operations Leadership

• Direct day-to-day Quality Operations activities supporting manufacturing and laboratory operations.
• Ensure timely review and disposition of:
• Batch records
• CAPAs / Deviations / Investigations
• Change controls
• Validations
• Product impact assessments
• Lead batch disposition and product release decisions in accordance with established quality standards and regulatory requirements.
• Drive quality oversight on the manufacturing floor through active engagement and visible leadership.
• Establish robust metrics and dashboards to monitor product quality, process performance, compliance, and operational effectiveness.

FDA Compliance & Inspection Readiness

• Ensure compliance with:
• 21 CFR Parts 820, 210 and 211
• FDA Guidance Documents
• USP and compendial requirements
• ISO 13485 and ISO 14971, where applicable
• Maintain a state of continuous inspection readiness across manufacturing, laboratories, warehouses, and quality systems.
• Lead site preparation and hosting activities for:
• FDA inspections
• Customer audits
• Regulatory inspections or ISO certification
• Corporate audits
• Serve as primary Quality representative during regulatory inspections. Also provide updates or correspondence as needed to regulatory bodies.

Quality Control Chemistry & Microbiology Oversight

• Provide strategic oversight of QC Chemistry and Microbiology operations.
• Ensure laboratory systems comply with FDA expectations for:
• Method validation
• Data integrity
• Sample management
• Ensure scientifically sound testing programs for:
• Raw materials / components / finished goods
• Stability programs
• Environmental monitoring & utilities
• Oversee investigation and resolution of:
• OOS & OOT results
• Ensure compliance with applicable USP chapters and compendial requirements.

Quality System Management (QMS)Provide oversight and continuous improvement for all elements applicable to 21 CFR parts 820, 210, 211:

• CAPA program including investigations and non-conformances
• Design & Change Control
• Complaint Handling including all applicable post-market surveillance activities
• Product Quality Reviews / Annual Product Reviews
• Supplier Quality Management
• Internal Audit
• Training
• Data Integrity
• Documentation Management
• Risk Management
• Ensure quality systems are compliant, effective, measurable, and inspection ready.

Manufacturing & Technical Operations Support

• Provide Quality oversight for manufacturing operations.
• Support:
• Process and Equipment Validations
• Critical utilities validation
• Review and approve validation protocols, reports, and quality impacting technical documents.
• Partner with Manufacturing to improve process capability, reduce deviations, and improve overall performance.

CAPA, Deviations & Risk Management

• Lead investigations into:
• Deviations, Non-conformances, OOS
• Customer complaints
• Ensure timely implementation of CAPAs
• Apply risk management principles aligned with ISO 14971 to identify and mitigate potential product risks.
• Track effectiveness of corrective actions and ensure closure within defined timelines.

Supplier Quality & Material Controls

• Lead supplier qualification and monitoring programs.
• Ensure compliance with material testing requirements under 21 CFR 211.84.
• Oversee supplier audits and quality agreements.
• Ensure robust controls for:
• Raw materials / Packaging components
• Contract laboratories
• Contract manufacturers

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.