Associate Director Global QA Strategic Projects
Associate Director Global QA Strategic Projects
Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women's Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world's leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to e nsuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear.
Bayer’s corporate culture is an important factor in the company’s success. Central to this culture are our values: Leadership, Integrity, Flexibility and Efficiency, summarized by the term LIFE. They provide us with guidance for our daily work as we seek solutions to the major challenges of our time, in line with our mission statement “Bayer: Science For A Better Life". Strategic Projects We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events. If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Provides oversight for the implementation of new and existing capacity in support of Biotech products. Accountable as business process owner for assigned processes, ensuring adequate quality oversight, including but not limited to compliance and validation issues. Responsibilities include direct support to process transfers. Partners with site Quality Units to ensure alignment and compliance with directives and regulatory guidance.
Other responsibilities include:
• Serves as a QA representative on project teams relating to expansion and possible green-field build of facilities to support biotech product manufacturing & testing • Tracks Quality related commitments and leads the execution and implementation of improvements in support of biotech products. • Reviews GMP documents as part of global Quality Oversight for biotech products and related capital projects. (Validation Plans, Protocols, Technical Reports, SOPs, etc.). • Completes regular KPI and status reports as needed for an effective communication of progress and issues to key stakeholders. • Interacts with various stakeholders to provide guidance surrounding process transfers between facilities. • Maintains awareness of current GMP trends and international GMP requirements. • Reviews unit operations, process design, process implementation and production workflows to provide effective quality assurance. This position requires a B.S. in Pharmacy, Biochemistry, Chemistry, pharmaceutical/chemical/industrial engineering or related field. An M.S. degree is preferred. The position also requires 8+ years of experience in the biopharmaceutical, biotech industry, or an equivalent combination of education and experience. 5+ years experience in Quality Assurance/Quality Control role. Additional requirements: • Must have a thorough working knowledge of cGMPs, GLPs, ISO, FDA and EU regulatory requirements. Knowledge of Quality System Regulation (QSR), GXP, GAMP and SDLC. • Advanced knowledge and experience in biopharmaceutical technical areas including: Manufacturing of bulk, intermediates and final drug products; Product disposition and release; Product inspection and labeling; Aseptic processing; Facility design. • Demonstrated ability to influence others. Excellent verbal and written communication skills. Ability to establish internal and external global collaborations • Strong analytical and problem solving skills • Strong and relevant project management skills with a history of success in timely delivery of scheduled milestones. Ability to effectively manage multiple priorities.
Bayer is an Equal Opportunity Employer
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