Director, QC Systems and Stability

About This Role:

As the Director of Global QC Systems and Stability, you will be at the helm of a global quality control department that plays a critical role in supporting both manufacturing operations and release stability testing laboratories. Your leadership will guide the department in managing Contract Laboratory Management, Planning and Scheduling, QC Enterprise System Management (LIMS), Specification/Stability programs, and Reference Standards and Qualified Materials (RSMQ) Teams. Building strategic relationships with Site Quality Operations, key internal and external partners, IT, and Senior Leadership will be essential to support daily operations in both external and internal manufacturing environments.

You will harmonize and streamline processes, maintain SmartQC and LabWare LIMS, oversee global projects, and implement specifications and stability strategies for biologics, small molecules, and oligonucleotides products. You will also oversee a global team responsible for monitoring QC method performance, optimizing assay control trending, and managing Qualified Materials, Reference Standards, Critical Reagents, and cell-based materials essential for analytical testing.

This is a hybrid role to be based at our site in Research Triangle Park, NC or Cambridge, MA.

• Identify, define, and drive strategy and improvement projects to maximize efficiency, streamline processes, and increase productivity in QC data, systems, and stability.
• Staff senior-level QC personnel, ensuring their training and performance align with GMP compliant Quality Control operations.
• Oversee the development and maintenance of budget plans for Contract Laboratory Operations OpEx (~$15-16MM).
• Supervise activities at multiple Contract Laboratory Organizations (CLOs) supporting Biogen and Partner product testing, ensuring operational readiness.
• Lead a team to acquire, qualify, and maintain reference standards and qualified materials for global laboratory operations.
• Provide leadership and guidance to technical and operational staff in developing and implementing specification and stability strategies for various product modalities.
• Utilize appropriate statistical tools to evaluate and interpret stability data, and guide the creation of stability reports and regulatory sections.
• Serve as Business Process Owner (BPO) for Stability QMS and associated systems.
• Perform other duties as assigned, contributing to the department's overall success.

• Bachelor's degree (Advanced degree preferred) in related field with at least 12 years of experience in the pharmaceutical industry, preferably within a scientific-related field.
• Strong knowledge of regulatory, compliance, GMP, and laboratory testing, including troubleshooting and root cause investigations.
• Comprehensive understanding of cGMPs, GLPs, and related global regulatory requirements.
• Proven matrix leadership capability with effective verbal and written communication skills.
• Strong analytical, critical thinking, and interpersonal skills.

• Experience in utilizing statistical tools and methodologies to evaluate and interpret stability data.
• Ability to synthesize technical information for senior management.

• 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