Associate Director, Quality Assurance – Governance

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Clinical Quality & Compliance representative for designated studies, programs, and functional areas.

• Assist in the development, maintenance, and ongoing enhancement of the Quality Management System.

• Propel quality governance, process improvements, and compliance initiatives.

• Direct quality oversight activities for clinical studies and programs, including Study Risk Assessments, quality health assessments, trend analyses, and risk mitigation strategies.

• Offer strategic leadership and consultation on Good Clinical Practice (GCP) requirements, quality standards, and regulatory expectations.

• Manage and authorize investigations concerning deviations, non-conformances, protocol compliance issues, and other GCP-regulated quality events.

• Supervise root cause analysis, development of CAPA, implementation, and verification of effectiveness.

• Lead Vendor Quality Governance efforts, encompassing vendor qualification, performance oversight, quality risk assessments, issue management, and remediation efforts.

• Collaborate with vendor quality representatives and internal stakeholders to ensure vendor compliance.

• Support internal audits, sponsor audits, investigator site audits, and regulatory inspections.

• Recognize emerging compliance risks and suggest proactive mitigation strategies.

• Spearhead cross-functional quality improvement initiatives.

• Track quality trends and metrics, providing insights and recommendations for decision-making and continuous enhancement.

⛳️ Requirements

• Bachelor’s degree in a scientific, healthcare, or related field.

• At least 10 years of experience in Clinical Operations, Clinical Quality, Compliance, Quality Assurance, or related pharmaceutical/biotechnology roles.

• Comprehensive understanding of Good Clinical Practice (GCP) regulations and global clinical development requirements, including FDA regulations, ICH guidelines, and relevant international regulations.

• Proven experience in providing quality oversight within clinical development programs and studies.

• Experience in leading investigations, conducting root cause analyses, developing CAPA, implementing solutions, and verifying effectiveness.

• Strong grasp of Quality Management Systems (QMS), risk management principles, quality metrics, and continuous improvement methodologies.

• Experience in supporting regulatory inspections, sponsor audits, and internal audit activities.

• Familiarity with vendor oversight and Vendor Quality Governance activities.

• Excellent analytical, problem-solving, organizational, and decision-making abilities.

• Outstanding written, verbal, facilitation, and stakeholder management skills.

• Demonstrated capacity to influence without direct authority and collaborate effectively across various functions and organizational levels.

• Ability to independently handle competing priorities while ensuring a high level of quality and attention to detail.

• Expertise in clinical trial systems and processes is required.

• A Master's degree or other advanced qualifications in Life Sciences, Quality, Regulatory Affairs, Healthcare, or a related field is preferred.

• Preference for candidates with regulatory inspection management experience.

• Prior experience serving as a Functional Quality Representative (FQR) for clinical studies is preferred.

• Familiarity with Study Risk Assessments, quality governance frameworks, and quality-by-design methodologies is preferred.

• Experience leading cross-functional quality transformation or process improvement initiatives is preferred.

• Prior leadership, coaching, or mentoring experience is strongly preferred.

• Candidates located within the Eastern or Central Time Zones are strongly preferred.

• Must have legal authorization to work in the United States, as Biogen is an E-Verify Employer in the United States.

🏝️ Benefits

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.

• Medical, Dental, Vision, & Life insurance options.

• Fitness & Wellness programs, including reimbursement for fitness expenses.

• Short- and Long-Term Disability insurance coverage.

• A minimum of 15 days of paid vacation annually.

• Additional time off during year-end shutdown (December 26 to December 31).

• Up to 12 company-paid holidays per year.

• 3 paid days off for Personal Significance.

• 80 hours of sick leave available each calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan access.

• Tuition reimbursement of up to $10,000 per calendar year.

• Opportunities to engage with Employee Resource Groups.

• Opportunities for learning, professional growth, and skill expansion.