Posted: Friday, March 9, 2018 12:12 AM
This role will lead the Quality Assurance and Quality Control functions at SPI’s Lewes manufacturing site and reports directly to the Director of Corporate Quality and Regulatory.
The primary objective of this position is to ensure 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, Newcastle 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 reflect business unit performance, quality requirements, taking a proactive approach to cost center management.
Develop and implement capital projects where appropriate.
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
Drives accountability within the organization
Leads by example and actively engages appropriate personnel to make informed decisive decisions
Effective clear and concise communication
Ability to work and lead in a diverse, global organization
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 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
The position will be located at the SPI Pharma Lewes Manufacturing Site with occasional travel to the Wilmington, DE corporate site and other SPI facilities on an infrequent basis.
Please send all qualified resumes through LinkedIn apply button or email resume to Kschmidt@spipharma.com.
• Location: Lewes, DE
• Post ID: 8601597 delaware