Quality Site Head (2011586) at Omaha

Job Description

Perrigo is the worlds largest manufacturer of over-the-counter pharmaceutical and nutritional products for the store brand and contract manufacturing markets and an emerging developer, manufacturer and marketer of prescription generic drugs.

Overview

Manage and provide leadership direction to Quality Assurance and the Quality Control Units and is responsible for quality unit approval and release of product. This position is the primary site contact for the regulatory agencies (i.e. EPA, FDA, MHRA, TGA, MOH and SFDA and leads all regulatory agency inspection activities and responses.

Major Duties:

• Insure that the site’s quality system is consistent with all Perrigo core values and global policies and applicable standards. Meet all local, state, and federal regulatory requirements for the manufacturing, packaging, labeling and holding/release of products and consumer complaint reporting obligations.
• Coach/mentor/develop Managers, Supervisors, and staff.
• Manage Quality resources (staffing, facility, equipment) to meet work flow needs for QC, QA and Consumer Affairs. Review and prepare annual Quality budget and ensure the site meets budget/flex targets for expenses and for Total Cost of Quality.
• Drive Continuous Improvement at the site from a Quality and Compliance perspective.
• Review and guide site response for critical quality and compliance issues (i.e. critical deviations, customer complaints, regulatory or 3rd party audits, CAPA compliance, trend investigations, stability OOS). Act as facilities’ primary contact with the regulatory agency. Lead and coordinate inspections at the manufacturing site.

Job Requirements

• Bachelors Degree in a Scientific or Technical field.
• 15 Years Quality and or Operations experience with progressive management experience in a multi-agency regulated environment.
• Experience in implementing a Quality System
• Experience in animal health or pet care products manufacturing preferred.
• Strong working knowledge of process improvement such as Lean and Six Sigma principles and practical applications in a Quality system is required.
• Excellent communication and interpersonal skills (both written and oral). The ability to effectively communicate with a diverse audience including regulatory representatives, R&D scientists, technical operations personnel, operations specialists, lab chemists and consumers/customers, is required.
• Strong leadership skills to both lead the onsite quality team and also serve as part of the overall site leadership team.
• Strong technical skills desired including the ability to review and/or prepare technical reports.
• Ability to effectively manage and allocated resources such as lab equipment and personnel.

Country: USA, State: Nebraska, City: Omaha, Company: Perrigo.