Executes planned and systematic activities implemented in a quality system so that quality requirements for products, processes, systems or equipment will be fulfilled. Those activities include the planning and development of processes, procedures and test plans in order to ensure that products manufactured meet internal, customer and regulatory requirements.
Key Objectives of the role:
- Designs quality assurance programs and systems for product and/or process development, manufacturing and testing to ensure product quality and compliance with regulatory requirements.
- Leads teams, quality, R&D and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and/or products are developed, tests are conducted and that products, materials, and manufacturing equipment meet required standards.
- Uses expert product and process knowledge to contribute to new product and process design teams
- Performs complex statistical analysis to analyze trends, and works with manufacturing to investigate, conduct root cause analysis, recommend corrective actions for processes and products and to contribute to and track data to support at the site level (e.g. yield improvements, CAPA, complaint and scrap reduction)
- Leads teams to conduct root cause analysis
- Works directly with customers on complex critical quality issues/complaints. Leads issue/complaint resolution
- Interfaces with suppliers and vendors to help resolve complex quality issues (e.g., investigations, troubleshoots raw materials issues). Leads resolution of issues
- Influences site quality goals & objectives based on in-depth knowledge of quality standards (i.e., ISO, GMP, etc). Act as a subject matter expert when determining clarifications and compliance to written standards, providing additional information for the site to ensure consistent application of quality processes
- Leads projects of moderate scope (may be cross functional or involve multiple teams)
- Works on complex issues and is guided by expected outcomes
- Acts as an advisor/coach to mentor other team members
- Provides quality specific training and guidance to the organization (e.g. Six Sigma programs) to correctly identify, define, and quality problems early
Expert knowledge of:
- Compliance with quality standards (e.g., EU GMP, 21 CFR Part 210, 211, 820, ISO 13485, 9001)
- Advanced quality tools, (e.g.: SPC, DOE).
- Quality tools e.g. FMEA, Risk Analysis,
- Site specific software programs (change control notification program, CAPA, etc.).
- Global Systems e.g. Trackwise, AGILE, E1/SAP
Minimum Qualifications (must have):
- Bachelor’s degree from accredited college/university or equivalent experience. Preferred Science or Engineering Degree
- Minimum of 7 years of relevant quality experience in Medical device or Pharmaceutical industry and 1 year of demonstrated leadership experience preferred (e.g. leading/supervising a project or a team
- Quality standards (e.g., 21 CFR Part 820 and ISO 13485)
- Experience with US Pharmacopeia, European Pharmacopeia, Japanese Pharmacopeia and British Pharmacopeia testing
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