The Principal External Manufacturing Quality Specialist will lead compliant execution of quality-related activities, including but not limited to, new quality system/methodologies implementation, training, CAPA, change management, problem solving, product and process development, acceptance activities.
This position will also work directly with Valeant Finished Good (FG)/External Manufacturing (EM) suppliers, as well as medical device/Pharmaceutical product manufacturing facilities, to provide sustaining quality and compliance leadership and routine support related to current commercialized products
In addition, the position is responsible for developing Product Annual Reports and measure, and report key quality metrics to drive quality and efficiency.
Identify and lead implementation of effective quality control systems at the Medical Device/Pharma/EM supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Lead and drive companywide quality planning continuous improvement projects (e.g. QSIP etc.)
Ensure Finished Good/External Manufacturing suppliers are compliant to all regulatory (US and International) and Valeant requirements
Provide leadership and support the North America supplier management team in identifying opportunities for improvements.
Complete Non-conformances and CAPAs related to FG/EM suppliers within required timelines.
Proactively investigate, identify and implement best-in-class Supplier Quality practices.
Provide technical mentorship and resolve quality supply chain issues with Valeant and FG/EM suppliers.
Lead quality disciplines, decisions, and practices across Bridgewater, NJ site.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with FG/EM suppliers.
Assist EM QA functions, supply chain and R&D organizations in sourcing new FG/EM suppliers.
Lead quality change request management activities, corrective and preventive actions as well as effectiveness verification activities, as required.
Assist quality management in all audits (FDA, Notified Body, other Regulatory agencies) that occur at the BW site
Directly support management team for activities related to Annual Product Reviews, Management Review, Complaint Review Board and Critical Action Committee.
Scope of Position:
The scope of this position is directly related to the Bridgewater NJ External Manufacturing.
The position will include routine interaction and communication with internal business stakeholders (Quality, Compliance, Supply Chain, R&D, Regulatory and Commercial) and external business partners (External Manufacturing groups).
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 but 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.
A minimum of 8 years within a supplier quality organization (minimum 4 years in the Medical Device or Pharmaceutical industry is required).
A Master’s degree in an engineering or technical related discipline may be substituted for two years of experience.
Demonstrated expertise in Implementing and maintaining quality systems with emphasis in Supplier management controls.
Ability to travel to supplier sites is required.
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.
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.
Experience in electronic quality system modules such as ComplianceWire, CATSWeb, Documentum, QlickView etc.
Expertise in providing creative solutions to complex issues.