Dir, Quality Operations

The Director, Quality Operations will be responsible to lead site-level Quality Control & Quality Assurance function activities, the Quality Management Systems (QMS), assure compliance to USA FDA GXP regulations across IVD products and all regulatory audit and inspection activities.

This position will be responsible for translating the company’s quality strategy into SOPs, tactical policies, processes, and procedures to always ensure compliance with meeting global regulatory standards.

The scope of the role includes but is not limited to Raw Material / Component release, Quality & Validation Engineering, and Site Compliance & Inspection Readiness. The role is responsible for developing both short-term tactical objectives and execution plans in addition to longer term strategies to drive efficiencies through simplification of Quality processes and procedures while driving continuous improvement in manufacturing quality, product quality and compliance performance.

• Oversees day to day Quality Operations activities at the site as required to support Operations including Raw Material & Component Release, Maintenance of the Site Master Validation Plan, Quality Engineering with oversight for Root Cause Investigation, Product Disposition, Corrective & Preventative Action.
• Collaborate with other members of the Global Quality & Compliance organization and will lead teams on the identification and standardization of best practices to drive both compliance excellence and process efficiency.
• Drives implementation plan of controlled document management, review and approve various GxP documentation, including master batch records, specifications,
• methods, and validation protocols, equipment qualification documents. (e.g., process, method, etc.), Change control management.
• Responsible for incoming raw material management, including receiving, inspection, storage, issuance.
• Oversee the storage, distribution, and management of Galaxy laboratory reagents and consumables related to the Clinical trial operation ensuring supplies are readily available for the lab when needed.
• Monitor inventory levels and collaborate with the procurement, R & D leadership team on forecasts to ensure sufficient stock while minimizing excess inventory and associated costs.
• Implement inventory control measures to prevent stockouts and overstock situations.
• Manage the organization and layout of the warehouse to maximize space utilization and ease of access, yet maintained in compliance with FDA, ISO, and CAP/CLIA regulations and safety standards.
• Collaborates with Operations and procurement leaders to identify potential areas of process and product variability, addresses root causes and implements improvements through the CAPA process to ensure the flow of quality products through the supply chain.
• Implement policies and procedures to maintain an effective equipment program including procurement in collaboration with Biomedical Engineering function.
• Manage and direct effective maintenance and calibration programs, equipment safety programs, and equipment utilization.
• Ensures company preventive maintenance programs are in place for all equipment.
• Directs activities to ensure that the site is in a continued state of compliance and inspection readiness including analysis and evaluation of data and presentation to senior management to ensure that resources are sufficient, and projects are appropriately prioritized in alignment with regulatory requirements and business goals.
• Utilizes data to assess the overall health and effectiveness of the Quality Operations processes / systems and identification of areas for process improvement.
• Leads strategy development at the site level and supports at the global level execution of a pipeline of continuous improvement initiatives to drive simplification, reliability, and overall effectiveness of Quality processes.
• Other duties as assigned.

Required Work Experience:

• A minimum of 8-10 years’ experience in the Pharmaceutical, Medical Device or Biotech Industry with a strong preference for leadership experience in a functional Quality role.
• Experience in project management and continuous improvement methodologies (e.g. Six Sigma, Lean, Total Quality Management) preferred.

Preferred Work Experience:

• N/A

Physical and Mental Requirements:

• N/A

Knowledge:

• Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, GMP Operations as well as a good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.
• Working knowledge of both FDA 21CFR Part 820 Quality Systems Regulations, ISO13485 standards, and CLIA, CAP, FDA requirements
• Demonstrated knowledge of business impact of compliance issues and risk management.

Skills:

• Strong working relationships with Operations, Procurement, R&D, Regulatory Affairs, and the broader Global Quality & Compliance organization are necessary to drive effective prioritization and collaboration to meet the needs of the business.
• Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment.
• Ability to host / manage external Quality System inspections is required with a preference for experience gained with hosting FDA and other health authority inspections.
• Highly collaborative and leads by example with a servant leadership model.
• Ability and willingness to roll up sleeves and engage to resolve day-to-day issues.

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets