Published: December 4, 2017
- Lead the development and implementation of Quality Management Systems aligned to regulatory agencies, customers, company requirements and industry best practices.
- Provide direction and ensure a Regulatory Surveillance program is maintained to assess regulatory impact of new and/or propose regulations/guidelines.
- Own all processes related to Site’s Quality Framework, Deviations, CAPA’s Change Control, Complaints, Quality Agreements, Supplier Program, Audits, Quality Metrics, GMP Training, Periodic Review / Annual Review Programs, etc.
- Manages compliance with state, federal, and all other applicable regulations and licensing requirements.
- Manages regulatory and clients’ audits, Site’s Audit program (internal and external), and Work with Clients in Field Alerts, Recalls requirements.
- Lead Site’s Inspection readiness and management of inspection outcomes and commitments.
- Manage Site’s Quality Management Review Program.
- Implement and maintain a Quality Risk Management program. Coordinate risk management plans on products, processes, and systems working with cross-functional Leadership Teams to mitigate risks.
- Develops quality assurance plans by conducting hazard analysis, identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, corrective actions, and verification procedures.
- Provide guidance, Analyze, and solve complex problems and High risk GMP investigations using statistics tools, capability studies, measurement system variation, and problem-solving methodologies. Methods include developing, implementing, leading, training, monitoring, measuring, analyzing, challenging, and trending. Provides leadership for problem resolution to facilitate faster improvements and improve working relations.
- Achieves quality objectives by contributing information and analysis to strategic plans and reviews, preparing and completing action plans, implementing productivity, quality, and customer-service standards, identifying and resolving problems, completing audits, determining system improvements, and implementing change.
- Builds company image by collaborating with clients, government, community organizations, and employees; enforcing ethical business practices.
- Interact frequently with Regulatory Agencies, Clients’, Corporate, and Supplier Quality representatives. Solid knowledge of the cGMPs, FDA, ICH, ISPE Guidelines
- Comply with all environmental trainings, procedures, guidelines, practices, cGMP’s, permit conditions and internal notifications of any environmental event.
- Perform any other job-related duties as required or that may arise in the future.
- Bachelor’s Degree in an Engineering or Science.
- Minimum of ten (10) years of experience in a Pharmaceutical manufacturing industry; GMP.
- Experience in Regulatory Affairs, Project Management, Risk Management, Quality and Regulatory Agency Auditing, Operations Processes.
- CQA and/or CQE; preferred
- Strong business acumen, interpersonal and performance management skills
- Strong verbal and written communications skills for multi-level stakeholders, including the ability to negotiate win-win solutions to drive standardization are required. Ability to interact with, influence, and lead cross-functional, cross-business unit teams is required.
- Strong strategic planning and tactical execution abilities, including strong organization skills is required.
- Ability to take initiative regarding innovative approaches to problem solving in a fast-paced, changing business environment is required.
- Process / Business Excellence and Lean experience; Process improvement; Computer literate and knowledgeable of statistics; Full knowledge of management principles; project management
- Pharmacology and Quality Engineering knowledge
- Fully bilingual (English & Spanish) required