Director, QC Systems and Stability

Responsibilities

• 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.

Requirements

• Required Skills:
• 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.
• Job Level: Management
• Additional Information
• The base compensation range for this role is: $178,000.00-$245,000.00
• 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 benefi

Benefits

Additional Information

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.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Biogen? Share your experience