Leads Quality Assurance and Governance for clinical studies, overseeing the Quality Management System (QMS), risk management, and GCP/FDA compliance. Handles investigations, CAPA, vendor governance, and ensures inspection readiness for R&D.
Compensation
$148K–$204K / yr
Location
Not listed
Work setup
Remote
Seniority
Not specified
Employment
Contract
Experience
10+ years
Category
Qa
Posted
Skills
gcp
process-improvement
regulatory-compliance
risk-assessment
root-cause-analysis
stakeholder-management
Must have
Bachelor’s degree in a scientific, healthcare, or related discipline
10+ years of experience in Clinical Operations, Clinical Quality, Compliance, QA, or related functions
Knowledge of GCP regulations, FDA regulations, and ICH guidelines
Quality oversight experience within clinical development programs
Experience leading investigations, root cause analyses, and CAPA
Understanding of Quality Management Systems and risk management
Experience supporting regulatory inspections and audits
Experience with vendor oversight and Vendor Quality Governance
The Associate Director, Clinical Quality & Compliance (CQC), serves as a strategic quality leader within R&D Quality & Compliance (RDQC), providing oversight, guidance, and expertise to support the effectiveness of the Quality Management System (QMS) across Research, Development, and Medical (RD&M).
This role is responsible for driving a culture of quality and compliance through leadership of Vendor Quality Governance activities, Functional Quality Representation (FQR) for clinical studies, quality risk management, investigations, CAPA oversight, inspection readiness, and continuous improvement initiatives. The Associate Director partners closely with cross-functional stakeholders to proactively identify quality risks, implement sustainable solutions, and ensure compliance with applicable global regulatory requirements and industry standards.
The incumbent plays a critical role in protecting study participants, preserving scientific integrity, and ensuring the quality and reliability of clinical data throughout the development lifecycle.
While this is a remote-based role, it is strongly preferred that the employee is located within either the Eastern or Central Time Zones. What You’ll Do
Serve as the Clinical Quality & Compliance representative for assigned studies, programs, and functional areas, providing expert guidance on quality and compliance matters.
Support the development, maintenance, and continuous improvement of the Quality Management System by driving quality governance, process enhancement, and compliance initiatives.
Lead quality oversight activities for clinical studies and programs, including Study Risk Assessments (SRAs), quality health assessments, trend analyses, and risk mitigation planning.
Provide strategic leadership and consultation to study teams and functional stakeholders 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 to ensure sustainable issue resolution and continuous improvement.
Drive Vendor Quality Governance activities, including vendor qualification, performance oversight, quality risk assessments, issue management, and remediation activities.
Partner with vendor quality representatives and internal stakeholders to ensure vendor compliance with global regulations, industry standards, and contractual quality obligations.
Support internal audits, sponsor audits, investigator site audits, and regulatory inspections through preparation, risk assessment, response management, and inspection readiness activities.
Identify emerging compliance risks and recommend proactive mitigation strategies that strengthen quality performance and organizational readiness.
Lead cross-functional quality improvement initiatives that enhance operational effectiveness, inspection readiness, and regulatory compliance.
Monitor quality trends and metrics, providing insights and recommendations to support informed decision-making and continuous quality improvement.
Who You Are
You are a strategic and collaborative quality professional with deep expertise in clinical development, GCP compliance, and quality systems. You are comfortable operating independently, influencing cross-functional stakeholders, and providing practical solutions to complex quality and compliance challenges. You excel in risk-based decision making, foster strong partnerships across functions, and are passionate about advancing a culture of quality that supports both patient safety and business objectives. You bring strong leadership, analytical thinking, and communication skills, along with a commitment to continuous improvement and operational excellence.
Required Skills
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.
Preferred Skills
Master's degree or other advanced degree in Life Sciences, Quality, Regulatory Affairs, Healthcare, or a related discipline.
Regulatory inspection management experience.
Experience serving as a Functional Quality Representative (FQR) for clinical studies.
Experience with Study Risk Assessments, quality governance frameworks, and quality-by-design methodologies.
Experience leading cross-functional quality transformation or process improvement initiatives.
Prior leadership, coaching, or mentoring experience strongly preferred.
Location within either the Eastern or Central Time Zones strongly preferred.
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 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.
Job Level: Management
Additional Information
The base compensation range for this role is: $148,000.00-$204,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
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 and an 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
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 Biogen.
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. Biogen is an E-Verify Employer in the United States.
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