Site Quality HeadLewes, DE
This role will lead the Quality Assurance and Quality Control functions at SPI’s Lewes manufacturing site and reports to the Director of Corporate Quality and Regulatory with operational accountability to the Site General Manager.
The primary objective of this position is to ensure in a timely manner the integrity of all products manufactured under the governance of the Lewes Management Team, ensuring that they are compliant with regulatory requirements and consistent with customer specifications.
The position will establish and maintain risk-based quality systems, provide a robust analytical data service to enable effective manufacturing process control and plant optimization and promote GMP across all functional teams at the Lewes site.
Essential Duties and Responsibilities
- Responsible for leading and directing all QA and QC activities associated with manufacturing activity at Lewes, New Castle and contract manufacturing/laboratory organizations as required.
- As an active member of the Site Leadership Team, be the voice of authority on matters relating to quality and regulatory compliance and ensure these receive appropriate focus and prioritization.
- Serving as an internal customer champion make recommendations to cross functional teams to continuously improve the quality of the products and services.
- Operate a Quality Control function that supports the manufacturing process providing timely, accurate data with sufficient flexibility to respond to the changing demands of the production schedule.
- Manage and develop the site Quality Team and provide mentoring and guidance to site personnel cross all functions to build a strong quality driven culture
- Collaborate and contribute to policy, procedure and system harmonization across sites
- Prioritize department goals and activity based on business requirements
- Be the lead contact for all customer audits and regulatory inspections
- Review/Approve all Compliance Documents as required by SPI policies and procedures
- Ensure effective root cause analysis and implementation of effective CAPA programs
- Reporting of key quality metrics and performance to site and corporate management, monitor trends and provide insight to drive improvement.
- Ensure site validation plan is maintained and implemented
- Set and manage site quality financial budget to support business unit performance improvement, quality requirements, taking a proactive approach to cost center management.
- Develop and implement capital projects where appropriate.
This position will have three (3) direct reports.
Education and/or Experience
- Minimum B.S. in Chemistry or related science field
- 10-15 years’ experience in Pharmaceutical industry with minimum of 5 years’ Quality Management experience ideally in a continuous process plant setting
- Lab operations (QC) and service delivery
- Knowledge of pharmaceutical regulations applicable to API and Drug Product manufacturing
- Experience effectively leading complex investigations with cross functional teams
- Experience hosting and managing customer audits and regulatory inspections
- Experience with current requirements for Process Validation
- Demonstrate 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 with lean, six-sigma preferred but not required