Associate Director, Quality Assurance & Governance

Summary

Join Biogen as the Associate Director, Quality Assurance & Governance - R&D Quality & Compliance (RDQC) and provide strategic guidance, oversight, and support for quality activities within the Quality Management System (QMS). You will be responsible for ensuring quality oversight of regulatory inspections, driving resolution to inspection findings, leading the development and maintenance of the R&D Audit infrastructure, and overseeing the operational process refinement efforts. This role requires a strong understanding of GxP regulations and experience in quality management, regulatory inspections, and audits.

Requirements

• Bachelor’s degree required
• 8 years’ Clinical Trial experience working in the biotechnology or pharmaceutical industry required; work with CROs highly desirable
• 6 years’ experience in a quality role required
• Experience with regulatory inspections and audits required
• Experience with Quality Management Systems required
• Extensive knowledge of the principles GxP regulations, including, GCP, GVP and preferably GLP, required
• Experience in process development and process improvement required
• High attention to detail, including proven ability to manage multiple, competing priorities, and strong problem-solving and communication skills, required
• Ability to Influence the opinions and decision making of others internally or with external partners/vendor/customers required

Responsibilities

• Serve as an accountable party for ensuring quality oversight of regulatory inspections by assisting in developing an inspection management framework, engaging in inspection readiness activities with clinical study teams and staging of key documentation for inspector review
• Responsible for driving resolution to regulatory health authority inspection findings and reporting in a timely manner to the relevant party
• Leads the development and maintenance of the R&D Audit infrastructure, including audit risk assessment and contribution to the Annual Audit Plan
• Provides oversight of end-to-end audit conduct by audit functional service providers or directly auditing stakeholders using applicable knowledge of GxP’s
• Oversees the operational process refinement efforts and potential execution of other quality management processes, including, risk management, and process improvement
• Responsible for overseeing relevant quality metrics; proactively assessing potential quality risks and recommends mitigating actions to drive quality metrics, in line with predetermined expectations

Preferred Qualifications

• Masters’ degree or PhD in Biology / Chemistry, Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred
• Work with CROs preferred

Benefits

• 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 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