Oversees parts of the pharmaceutical regulated quality system related to CAPA, nonconformance, document & records management, and change management to ensure compliance and resolution of issues.
The scope of this position is directly related to the Valeant External Manufacturing Quality Organization.
The position has supervisory responsibilities for a team of 4-8 quality professionals.
Oversee the following areas for management of workflow, compliance to Valeant directives/country regulations, process improvements, metric tracking and risk mitigation activities:
o Change Management
o Document Control
o Records Management
Supports the planning and execution of Quality compliance audits. Ensures that there are processes in place to monitor and measure all activities related to quality assurance performance improvement.
Develop, measure, and report key quality metrics to drive quality and efficiency.
Proactively investigate, identify and implement best-in-class quality practices.
Establish process model for quality improvement and provides training to organization personnel.
Provide effective leadership in supporting quality disciplines, decisions, and practices for Bridgewater site.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Internal Customers/Business Partners:
Regulatory Affairs (NA)
Research and Development
Quality Assurance &Compliance Senior Leadership (NA)
External Customers and Business Partners:
- Finished Goods / External Manufacturing Suppliers
Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
Bachelor of Science degree in an engineering discipline (Mechanical, Biomedics, materials, Industrial, etc) or related technical field (microbiology, chemistry, etc) is required.
ASQ Certification preferred by not required (such as CQA, CQE, CMQ/QE)
Excellent communication skills (verbal and written).
Ability to successfully influence others within project teams regarding quality or compliance concerns.
Excellent organizations and presentation skills.
Ability to hold people and functions accountable for resolving product quality issues, identifying root cause, implementing corrective and preventative actions and performing effective verification activities.
Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment.
Familiar with 21 CFR Part 210, 211, 820, ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive) and Canadian Medical Devices Regulations.
Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and ability to mentor stakeholders in analysis of process data and metrics to identify root cause of complex problems and development and implementation of preventative or corrective actions.
Expertise in providing creative solutions to complex issues.
A minimum of 10 years within a quality organization (minimum 4 years in the Medical Device or Pharmaceutical industry is required).
3-5 years’ experience supervising professional level employees.