Essential Job Functions:
- Carries out managerial responsibilities in accordance with the organizations policies, procedures and state, federal and local laws.
- Leads the Operational Quality Organization within the US Operations
- Ensures compliance to applicable Regulatory requirements and Company Quality Policy and Procedures
- Ensures effective Quality function partnership with other areas of Impax, including Compliance, Operations, R&D and IT.
- Ensures establishment, maintenance and effectiveness of the Quality System within Tech Ops. Ensures appropriate quality systems and procedures are in place and adhered to across all manufacturing sites.
- Ensures sites’ in compliance with FDA regulations utilizing internal and external auditing and in collaboration with operational organizations and Compliance Organization.
- Leads sites’ efforts during FDA inspections, ensuring issues and observations are properly addressed; interacts with FDA officials externally regarding issues of compliance impacting operations.
- Identifies, acquires, develops and deploys talent across the Operational Quality. Coordinates with Compliance on assessment, development and movement of QA employees across company Quality organizations.
- Develops and manages overall budget for Quality Operations.
- Actively participates in the development of Quality Policy and Procedures and its interpretation
- Leads Quality Operations projects and initiatives across the Operations.
Required Knowledge and Skills:
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), EU, DEA, OSHA and other pertinent compliance organizations and regulations.
- Principles of advanced mathematical and statistical computations.
- Strategic, long and short range planning principles and methods.
- Pharmaceutical processes, principles, practices and their application.
- Project Management principles and techniques.
- Current Company policies and procedures, including safety rules & regulations.
- Business English usage, spelling, grammar and punctuation.
- Computer systems and software applications.
- Budget preparation and management
- Leadership direction, training and development practices and methods.
- Researching, interpreting and analyzing reports, compliance requirements, regulations, contracts and data.
- Analyzing and troubleshooting problems, identifying potential solutions, recommending and implementing methods, procedures and/or techniques for resolution.
- Managing multiple projects.
- Communicating clearly and concisely, both orally and in writing. Polished presentation skills.
- Establishing and maintaining effective working relationships with individuals across a variety of organizations within the company. Skilled at influencing and negotiation.
- Responding to complex inquiries from management and regulatory agencies.
- Operating computer systems and software applications.
- Establishing organizational goals and objectives, developing and implementing plans to achieve them.
- Interpreting and applying Federal, State and local policies, laws and regulations and other country specific and applicable laws and regulations.
- BS Degree in Chemistry, Pharmacy, Biology, Life Sciences or related field from an accredited college or university and 10-15 years of management level Pharmaceutical Quality Assurance
, manufacturing or business experience; or an equivalent combination of education and/or experience.
Current experience in the PHARMACEUTICAL INDUSTRY IS REQUIRED.
Physical Requirements and Working Conditions:
Incumbents in this class are subject to extended periods of sitting, standing and walking. Vision to monitor, moderate noise levels and frequent business travel. Work is performed in an office, laboratory and manufacturing environments.