Associate Director, Quality Assurance – Governance

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $148k - $204k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Serve as the Clinical Quality & Compliance representative for assigned studies, programs, and functional areas. • Support development, maintenance, and continuous improvement of the Quality Management System. • Drive quality governance, process enhancement, and compliance initiatives. • Lead quality oversight activities for clinical studies and programs, including Study Risk Assessments, quality health assessments, trend analyses, and risk mitigation planning. • Provide strategic leadership and consultation on GCP requirements, quality standards, and regulatory expectations. • Lead and approve investigations related to deviations, non-conformances, protocol compliance concerns, and other GCP-regulated quality events. • Oversee root cause analysis, CAPA development, implementation, and effectiveness verification. • Drive Vendor Quality Governance activities, including vendor qualification, performance oversight, quality risk assessments, issue management, and remediation. • Partner with vendor quality representatives and internal stakeholders to ensure vendor compliance. • Support internal audits, sponsor audits, investigator site audits, and regulatory inspections. • Identify emerging compliance risks and recommend proactive mitigation strategies. • Lead cross-functional quality improvement initiatives. • Monitor quality trends and metrics, providing insights and recommendations for decision-making and continuous improvement.

🎯 Requirements

• Bachelor’s degree in a scientific, healthcare, or related discipline. • Minimum 10 years of experience in Clinical Operations, Clinical Quality, Compliance, Quality Assurance, or related pharmaceutical/biotechnology functions. • Extensive knowledge of Good Clinical Practice (GCP) regulations and global clinical development requirements, including FDA regulations, ICH guidelines, and applicable international regulations. • Demonstrated experience supporting quality oversight within clinical development programs and studies. • Experience leading investigations, root cause analyses, CAPA development, implementation, and effectiveness verification. • Strong understanding of Quality Management Systems (QMS), risk management principles, quality metrics, and continuous improvement methodologies. • Experience supporting regulatory inspections, sponsor audits, and internal audit activities. • Experience with vendor oversight and Vendor Quality Governance activities. • Strong analytical, problem-solving, organizational, and decision-making skills. • Excellent written, verbal, facilitation, and stakeholder management skills. • Proven ability to influence without authority and effectively collaborate across multiple functions and organizational levels. • Ability to independently manage competing priorities while maintaining a high level of quality and attention to detail. • Clinical trial systems and process expertise required. • Master's degree or other advanced degree in Life Sciences, Quality, Regulatory Affairs, Healthcare, or a related discipline preferred. • Regulatory inspection management experience preferred. • Experience serving as a Functional Quality Representative (FQR) for clinical studies preferred. • Experience with Study Risk Assessments, quality governance frameworks, and quality-by-design methodologies preferred. • Experience leading cross-functional quality transformation or process improvement initiatives preferred. • Prior leadership, coaching, or mentoring experience strongly preferred. • Location within either the Eastern or Central Time Zones strongly preferred. • Must be legally authorized to work in the United States, as indicated by Biogen being an E-Verify Employer in the United States.

🏖️ Benefits

• Short-term and long-term incentives, including cash bonus and equity incentive opportunities • Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation • Additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays • 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation • Opportunities for learning, growth, and expanding skills