- Oversees the Quality and Compliance functions for Valeant, world-wide.
- Assures that all Valeant products are manufactured or distributed are manufactured and tested in compliance with the different regulatory compliance standards.
- Oversees the establishment of Quality policies, systems, and procedures.
- Leads and monitors a quality GMP Compliance Audit Program. Oversees and authorizes internal and external audit /inspection responses and ensures harmonization of responses between all Valeant sites.
- Leads the design and/or re-design of quality systems to achieve compliance with regulatory and company standards and to achieve business excellence.
- Creates, maintains and implements a quality system documentation program that serves as the repository for Valeant’s standard practices ensuring alignment with applicable regulations.
- Oversees annual training requirements for all Valeant sites including metrics for content and frequency.
- Oversees the preparation of all Valeant manufacturing sites and functions for inspection readiness, including general GMP and pre-approval regulatory agency inspections.
- Oversees the Quality activities to assure that clinical supplies meet regulatory requirements for Good
- Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Oversees the validation and maintenance of data management systems to assure data integrity and compliance to requirements. electronic systems are appropriately validated and maintained
Direct Reports: Four direct reports, 25 secondary report = 29 total
Key Relationships: Senior leadership of Valeant including Quality, R&D, Operations and Regulatory Affairs.
- A BS degree is required; however, an advanced degree is preferred in chemistry, microbiology and/or engineering.
- Must be sufficiently knowledgeable to direct staffs at a Ph.D. level in product or process problem-solving in all technical specialties. .
- Because of the organizational size and diversified product line and technical structure of the organization, the incumbent must possess a good social ability to work with all the general managers across the business.
- Incumbent needs to possess excellent people skills to influence, motivate, teach and encourage direct staff as well as peers to understand and accept his/her recommendations.
- Demonstrated ability to exercise sound judgment and handle stress while maintaining a calm demeanor.
- A minimum of 12 years of experience in leading quality departments in both pharmaceutical and medical device organizations (with the preference for pharma experience).
- Must possess complete familiarity with current drug and device regulations and regulatory agency organizations.