Valeant Pharmaceuticals International, Inc. is a diverse and decentralized 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.
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and ophthalmic surgical devices and instruments. We globally develop, manufacture and market one of the most comprehensive product portfolios in our industry, which are available in more than 100 countries.
Eye health, ophthalmic pharmaceuticals, ophthalmic surgical products, contact lens and lens care products
The Sr Supplier Quality Engineer – External Manufacturing will work directly with Valeant/Bausch + Lomb External Manufacturing (EM) suppliers, to provide Quality Engineering and routine support related to current commercialized product as well as newly developed products and Tech Transfers.
In addition, the position will ensure finished product EM suppliers are compliant to all regulatory (US and International) and Valeant/B+L requirements regarding Validation.
Identify and implement effective quality systems at the finished EM supplier sites to support the development, qualification, and on-going manufacturing of EM products to meet or exceed internal and external requirements.
Support USA External Manufacturing Quality Assurance (EMQA) supplier management team in identifying opportunities for improvements.
The most important aspect of the position is to review process, equipment, cleaning and other validation reviews from the EM Product Suppliers. Also work with these suppliers to develop validation protocols and reports which meet regulatory requirements.
Complete Non-conformances and CAPAs including root cause investigations related to EM suppliers within required timelines.
Proactively investigate, identify and implement best-in-class Quality Engineering practices.
Provide technical mentorship and resolve quality supply chain issues with Valeant/ B+L EM suppliers.
Provide effective technical leadership in supporting quality disciplines, decisions, and practices across the USA region including but limited to the following:
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with EM suppliers.
Conduct technical, system, process and product audits for trouble shooting quality issues at EM suppliers.
Directly support EMQA Leadership Team for activities related to Management Review, Complaint Review Board and Critical Action Committee.
Work in conjunction with Senior Quality Engineer to resolve supplier issues.
The scope of this position is directly related to Valeant/B+L’s External Manufacturing Quality Assurance (EMQA) Organization.
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).
Internal Customers/Business Partners:
Research and Development
Global Product Surveillance and Safety, Pharmacovigilance
Design Quality Assurance
Compliance Senior Leadership
External Customers and Business Partners:
Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
Bachelor of Science degree in an engineering or life science discipline (Mechanical, Biomedics, materials, Industrial, Pharmaceuticals etc) or related technical field (microbiology, chemistry, etc.) is required.
ASQ CQE required
CQA Certification preferred. Audit experience preferred.
Excellent communication skills (verbal and written).
Ability to successfully influence others within project teams regarding quality or compliance concerns.
Excellent organization 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.
Able to generate and analyze complex quality data and articulate conclusion and recommendations for quality improvement utilize appropriate statistical techniques (DOE, SPC, Minitab etc)
A minimum of 7 years related Quality Engineering experience (Medical Device or Pharmaceutical industry is required).
Minimum of 5 years experience in Validation
A Master’s degree in an engineering or technical related discipline may be substituted for 2 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 111, 210, 211 820, ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive) and Canadian Medical Devices Regulations, ICH Q7A.
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.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Valeant’s Job Offer Fraud Statement.