Manager of Corporate QualityWilmington, DE
The Manager/Sr. Manager, Corporate Quality will develop, maintain and manage quality and regulatory systems with a focus that supports the manufacturing sites and global business initiatives. The position will work with Corporate Quality/Regulatory, Site and Senior Management to enable continuous improvement in establishing critical quality, regulatory and business systems and processes. Report to the Director of Corporate Quality and Regulatory
Essential Duties and Responsibilities
- Work with Quality and Regulatory Service Director (Bangalore) and Head of Quality and Regulatory to develop, implement, and maintain Global Quality & Regulatory Policies and Business Processes consistent with the Business and Quality and Regulatory strategy.
- Working with the Director of Corporate Quality and Regulatory, manage specific Quality Systems at the Corporate Level - Change Controls and Deviations
- Initiate and manage new Quality and Regulatory procedures and provide suggestions for continuous improvement
- Manage Global Quality Projects, as needed
- Participate in key industry related organizations representing SPI’s Quality position.
- As required, work with Site Quality Heads to assist and lead in investigations supporting the quality operations
- Primary contact for review and management of customer quality agreements
- Provide guidance and directions on Quality matters to the sites and management related to business operations and strategy
- Provide support and backup for the Director of Corporate Quality and Regulatory in daily activities and planning
- Oversee and manage corporate Quality team members
- Bachelor’s degree in an applicable science field with 7+ years’ experience in Pharmaceutical industry with minimum of 5 years in a Quality role
- Knowledge of pharmaceutical regulations and guidance applicable to Excipient, API and Drug Product manufacturing in a global environment
- Experience with managing Regulatory Inspections
- Experience developing, implementing and managing Quality systems and related processes.
- Demonstrated ability to organize self and others, with a positive, proactive approach to changing priorities
- A natural problem solver with a sound working knowledge of formal root cause analysis tools
- Experience managing projects using established Project Management skills and tools
- Understanding and experience in implementing robust Computer System Validation and Data Integrity programs
- Honesty, integrity, and the ability to work collaboratively, respectfully and safely
- A strong contributor with the ability to effectively manage up, down, and across the organization
- Leads by example and actively engages appropriate personnel to make informed decisions
- Effective clear and concise communication, both verbal and written
- Ability to plan and manage multiple priorities
- Ability to work and lead in a diverse, global organization with a sense of urgency
- Maintains external focus as it relates to customer and regulatory compliance expectations
- Knowledge and experience working with electronic document and quality management systems
- Ability to occasionally travel to other SPI sites.