Senior Quality Assurance Supervisor Biologics

2 weeks ago

Denver, Colorado, United States Biogen Full time
About the Role

We are seeking a highly skilled and experienced Senior Supervisor to join our Quality Assurance team at Biogen's Research Triangle Park facility. As a key member of our team, you will be responsible for ensuring compliance, driving excellence, and maintaining product integrity.

Key Responsibilities
  • Direct and develop team members to achieve high-quality results and meet production and compliance guidelines.
  • Coordinate and evaluate employees, ensuring adherence to site and Corporate policies, cGMP, safety, environmental, and human resources policies and procedures.
  • Evaluate, schedule, and balance departmental workload, managing projects, and adhering to regulatory licenses and regulations.
  • Support the QA Manager/Sr. Manager/Associate Director in activities related to interviewing, hiring, and training of employees, compliance with training policies, performance evaluations, and resolving employee-related issues.
  • Recommend changes to existing Quality systems and GMP processes, identifying gaps and proposing solutions to QA Management.
  • Assess batch acceptance and final batch disposition decision for clinical and commercial production batches, and provide QA approval of planned exceptions and investigations.
  • Work closely with Manufacturing and other support functions to troubleshoot compliance issues in real-time during manufacturing operations.
  • Escalate quality-related issues to Quality Management to maintain cGMP compliance and ensure the safety, efficacy, and purity of products manufactured by Biogen.
  • Support Quality Management and Operations staff in the coordination of internal/external audits and inspections, as required.
Requirements
  • Bachelor's Degree in a relevant scientific or technical discipline.
  • Minimum of 5 years of relevant life sciences experience within Quality Assurance and/or Quality-related functions.
  • Experience leading and developing a team.
  • Ability to lead change and complete initiatives aligned with the business.
  • Flexibility to respond to unexpected situations and demands.
About Biogen

We are a global team committed to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide stability and resources while fostering an environment where individual contributions make a significant impact. Our team encompasses talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. We work together to deliver life-changing medicines, with every role playing a vital part in our mission.

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.

We are an E-Verify Employer in the United States and an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual 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.

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