Manager, Quality Assurance Operations

Company: Thermo Fisher Scientific
Location: Carlsbad
Posted on: April 10, 2021

Job Description:

Job DescriptionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals At Microbial Material Services (MMS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative therapeutics. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. How will you make an impact? Leads and manages site Quality programs and activities to support contract manufacturing organization operations. This role oversees Quality On the Floor, Batch Record Generation, Review, and Approval. Provides leadership, strategic thinking, and results focus to reliably meet and/or exceed the site's production targets while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. Ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines. What will you do? * Participate as a member of the Site Quality Leadership Team and partners with the Operations management to identify quality issues and compliant solutions. * Support Manufacturing and Testing Operations during batch production, ensuring unexpected events are handled compliantly and in a timely manner. * Review and approve documents including: Manufacturing batch records in support of product release; Standard Operating Procedures, Process Validation Protocols and Reports. * Ensure timely completion of the site internal audit program. * Partner with functional leaders to identify key performance metrics and develop a plan for routine measurement. * Management of data review, analysis, identification of trends, and complex problem solving. * Manage problems of diverse scope using a high degree of judgment and risk-based decision making * Apprise senior management of critical issues. * Champion process improvement concepts. * Evaluate the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement. * Support a state of continuous inspection readiness How will you get here? Education * BS in a scientific life sciences or engineering discipline Experience * 2-3 years minimum experience in the disposition of finished products (biologics, pharmaceuticals, or medical device) required. * 7-10 years preferred experience in a quality leadership position. * Knowledge of GMP regulations in a cGMP environment. * At least 1 year of prior supervisory experience required * Ability to drive functional, technical and operational excellence. * Ability to inspire and foster innovation, collaboration, transparency and team effectiveness. * Ability to manage timelines and coordinate work schedules of employees. Knowledge, Skills, Abilities: * Ability to write reports, business correspondence and procedure manuals * Strong organizational skills; ability to prioritize and manage through complex processes/projects * Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, financial reports, governmental regulations and legal documents * Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community * Ability to define problems, collect data, establish facts and draw valid conclusions * Excellent communication skills * Ability to multitask, strategically and tactically * Excellent knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals. * Ability to apply GMP regulations and international guidelines to all aspects of the position * Ability to travel up to 10% Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon

Keywords: Thermo Fisher Scientific, San Diego , Manager, Quality Assurance Operations, Executive , Carlsbad, California