Location: Research Triangle Park
Company: Biogen
Ensure team is aligned with goals, objectives. Conduct performance evaluations for subordinates and ensure that employees are trained. Additional responsibilities include scheduling/balancing of team workload with respect to assignments, responsibilities, personnel, management of departmental milestones.
Accountable for approval of technical documents for team. Maintain tracking of workload and processes for team to ensure optimization and delivery. Responsible for ensuring GMP compliance, and alignment with quality systems. Responsible for applying that knowledge in coaching and continuous improvements of systems cross-functionally. What You'll Do Oversee team deliverables and sustainability
with timely communication for priorities. Properly escalates issues to senior QC management as applicable to impact for teams. Tracks & reports progress to tasks and departmental metrics to upper management, as applicable.
Effectively problem solve and reallocate resources as necessary. Provide leadership for QC initiatives as related to scientific, technical discipline, business strategy- global improvements. Lead complex projects and initiatives. Manage activities including technical writing, project representation that are complex and/or those with significant impact (routine or minimal complexity). Hire and develop a well-functioning team - focusing on values and culture. Ensure establishment
of goals and development plans for employees.
Ensure effective team training for group activities, responsibilities and performs performance reviews. Coordinates activities with other departments; provide updates to QC team mgmt. Routinely collaborate with Manufacturing, Engineering, Quality Assurance, PQM, Regulatory, TD, Validation, AT, cross site stakeholders etc. Provide microbial awareness and aseptic technique training in collaboration with site functions. Who You Are You love collaborating cross functionally to determine root cause and potential corrective actions. You enjoy motivating and developing a team to meet or exceed goals.
Qualifications Bachelor's Degree in science. 5 years of experience in GMP laboratory role/support role. At least 2 years of leadership experience in comparable role, experience with regulations, FDA/MHRA. Can effectively lead change & complete initiatives aligned with the business. Ability to flex and respond to unexpected situations, demands. Preferred Qualifications Master's Degree. Aseptic Technique/Processing, Environmental monitoring/Utility monitoring, microbial identification, bioburden, endotoxin, growth promotion, USP, EP, JP compendia Additional Information Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to interaction, gender identity or expression, interactionual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. PDN-9ae5e0e5-ae29-4f0d-8a62-4aa6b887a1a7
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
