Valeant Pharmaceuticals Senior Manager, Regional Quality Operations in Bridgewater, New Jersey
Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization's potential and what we hope it will become.
The Sr. Manager Regional Quality Operations is responsible for maintaining compliance of Quality Systems, and driving Operational Excellence across pharmaceutical sites in the Americas region including the coordination of projects and programs for compliance and quality operations improvements. Liaise with sites across regions and global functions in order to ensure effectiveness and efficiencies in Americas Quality Operations.
Primarily supports pharmaceutical sites in the Americas. May be requested to support external suppliers, other regions, and other business segments as needed.
Leadership experience required.
Direct the roll out of new Quality Systems initiatives across the Americas region. Works with Quality groups, sites and commercial affiliates in the Americas region to ensure proper resource allocation to include capital expenditures.
Leads the roll out of new or upgrades to IT applications within the Americas region. Works with other Quality groups, IT, sites and commercial affiliates to build business case, and to drive the roll out of electronic solutions.
Monitors the performance of Quality Systems and Operations in the Americas region. Performs trend analysis leading to both short and long term changes. Establishes risk mitigation activities as necessary.
Leads review boards for major non conformances, changes, audit observations, inspection findings, product quality complaints, etc. impacting the region(s) and/or requiring a coordinated response or actions across sites.
Supports sites and commercial affiliates with tools and guidance for quality systems and operational improvements
Regional coordinator for escalated quality events. Determines impact within the region and extend of the quality issue. Reconvene Critical Action Committee. Shares best practices and lessons learned.
Internal: Functional representatives within Valeant/Bausch + Lomb facilities in the Americas
Global Ops and Quality, IT, Ops, and RA
BS in Science or Engineering.
Knowledgeable of cGMPs for pharmaceutical products, international requirements, and quality system development and management.
Knowledgeable of statistical techniques and application experience. Demonstrated project management, excellent leadership and interpersonal skills, and strong written and oral communication. Second language such Spanish or Portuguese preferred.
Training and experience in validation, auditing, statistics preferred. Certified ASQ CQE and/or Lean Six Sigma Green belt preferred.
Training in problem solving tools is required (Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, and Pareto Analysis)
Strong Computer & Information Technology Skills (Windows, Word, Excel, Access, Power Point, Project, Visio , statistical software usage & principles.)
10-15 years quality experience, 7 years minimum in a pharma or medical device preferable in a site leadership position.
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Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job ID 10227
Pos. Type Full Time