Director, QC Systems and Stability
Biogen
2 months ago
Remote friendly (Triangle, NC)
United States
Operations
What You’ll Do
- 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 training and performance align with GMP compliant Quality Control operations.
- Oversee 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; guide creation of stability reports and regulatory sections.
- Serve as Business Process Owner (BPO) for Stability QMS and associated systems.
- Perform other duties as assigned.
Required Skills
- Bachelor’s degree (Advanced degree preferred) in related field; at least 12 years of pharmaceutical industry experience (preferably scientific-related).
- Strong knowledge of regulatory, compliance, GMP, and laboratory testing (troubleshooting and root cause investigations).
- Comprehensive understanding of cGMPs, GLPs, and global regulatory requirements.
- Proven matrix leadership with effective verbal and written communication.
- Strong analytical, critical thinking, and interpersonal skills.
- Experience using statistical tools/methodologies for stability data.
- Ability to synthesize technical information for senior management.
- 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 training and performance align with GMP compliant Quality Control operations.
- Oversee 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; guide creation of stability reports and regulatory sections.
- Serve as Business Process Owner (BPO) for Stability QMS and associated systems.
- Perform other duties as assigned.
Required Skills
- Bachelor’s degree (Advanced degree preferred) in related field; at least 12 years of pharmaceutical industry experience (preferably scientific-related).
- Strong knowledge of regulatory, compliance, GMP, and laboratory testing (troubleshooting and root cause investigations).
- Comprehensive understanding of cGMPs, GLPs, and global regulatory requirements.
- Proven matrix leadership with effective verbal and written communication.
- Strong analytical, critical thinking, and interpersonal skills.
- Experience using statistical tools/methodologies for stability data.
- Ability to synthesize technical information for senior management.