(Archived) Senior Associate Director, Quality Control

The Senior Associate Director, Quality Control 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, required. 10 years relevant industry experience in a GMP biological vaccine and/or pharmaceutical production environment, required. Experience must be inclusive of 5 years in a laboratory management environment leading a substantial number of employees. Master's degree and/or PHD, strongly preferred. Excellent reading / writing and communication skills. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older Who We Are: At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth. Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.