Senior Associate Director, Quality Control
Description
Provides leadership and technical direction of the Quality Control (QC) Operation groups according to company policies, corporate business plans and regulatory requirements (GLPs, cGMPs, US Department of Agriculture, Japanese and EU regulations, etc.). Directs and provides technical oversight and Regulatory and GXP compliance for the purity, potency, safety and stability testing of vaccines and intermediates. Provides technical competence of Quality Control areas through selection, training and development of staff, ensuring a safe and fiscally stable workforce ensuring a development of continuous improvement philosophy. Leads and promotes the implementation of new technologies while maintaining compliance and efficient QC processes.This position may serve as a deputy for the Director, Quality and Compliance in his/her absence. Responsible deputy during absence of the SR AD, Quality Control is AD Biological QC. Alternate deputy is Manager, Bio QC. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
Duties & Responsibilities
• Direct, lead, develop the Quality Control staff in oversight of the purity, potency and safety testing to ensure high quality bacterial and viral products. Administer and Drive company policies and safety program. Make hiring and discipline recommendations in accordance with policies and procedures. Develops and institutes quality efficiency improvements within areas of QC testing and analysis. Ensures QC workforce develops and maintains a positive, synergistic relationship with other operating departments and external stakeholders.
• Responsible for compliance with industry guidelines and governmental regulations, preparing, auditing, and reviewing test methods, test records and other GMP
• documentation, hosting inspections and audits of the QC areas. Establishes and maintains quality agreements with vendors, third-party manufacturers, and contractors.
• Evaluate and provide leadership support for annual expense and capital budgets for departments and monitor to stay within prescribed limits. Complete annual reviews of all production outlines, special outlines, etc.
• Leads the oversite of all testing of raw materials, in-process samples containers/closures, packaging materials, toll/contract manufactured products and BI vaccine manufactured products. Determines technical adequacy of the scientific documents and testing methods used within various Quality Control departments. Leads the oversite of test Master References and reagents that are developed internally and ensure compliance with Validation and Qualification of Quality Control assays.
• Directs administration of the BI biological stability program including evaluation of trends/testing at appropriate intervals. Participating in the review of design, manufacturing, purchasing, and test documentation to ensure that the company´s and customers´ quality requirements are met on products, programs, areas, and functions.
• Directs the oversight of data integrity with instrumentation and manual processes used throughout the Quality Control laboratories.
• Leads in coordinating the transfer of new products and technologies into QC. Support of site transfers through leadership and direction ensuring robust processes and compliance.
• Responsible for compliance with industry guidelines and governmental regulations, preparing, auditing, and reviewing method test records and other GMP
• documentation, hosting inspections and audits of the QC areas. Establishes and maintains quality agreements with vendors, third-party manufacturers, and contractors.
• Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH´s excellent reputation in the community.
Requirements
• Bachelor´s degree from an accredited institution in microbiology, chemistry or related scientific area and a minimum of ten (10) years relevant industry experience in a GMP biological vaccine and/or pharmaceutical production environment.
• Masters degree and/or PHD is strongly preferred.
• Experience must be inclusive of a minimum of five (5) years in a laboratory management environment leading a substantial number of employees
• Excellent reading / writing and communication skills.
Requirements
• Bachelor´s degree from an accredited institution in microbiology, chemistry or related scientific area and a minimum of ten (10) years relevant industry experience in a GMP biological vaccine and/or pharmaceutical production environment.
• Masters degree and/or PHD is strongly preferred.
• Experience must be inclusive of a minimum of five (5) years in a laboratory management environment leading a substantial number of employees
• Excellent reading / writing and communication skills.
Pharmaceutical Manufacturing
Quality Assurance
FULL_TIME