Similar Jobs
See allDirector, Clinical Quality Assurance (CQA)
Immunovant
US
GCP
Quality Assurance
Risk Management
Director, Commercial Manufacturing & Process Engineering
Deciphera
Manufacturing
Associate Director, CMC Lead, Late-Stage Biologics
Oruka Therapeutics
US
CMC
Regulatory
Senior Manager / Associate Director, Healthcare Compliance
Orca Bio
Associate Director, Regulatory Affairs CMC
Iovance Biotherapeutics
US
Regulatory Submissions
Project Management
Role Overview:
- Provide strategic and operational leadership for the Quality Control function.
- Ensure timely and compliant oversight of release and stability activities.
- Partner cross-functionally and externally to enable successful execution.
Key Responsibilities:
- Develop and execute the enterprise QC strategy.
- Ensure inspection readiness across QC operations.
- Serve as a strategic advisor on analytical and QC-related risks.
Qualifications:
- Bachelor’s degree in Chemistry, Biochemistry, Biology, or related field.
- 10+ years of Quality Control and analytical experience within GMP biopharmaceutical environments.
- Strong knowledge of cGMP regulations and global regulatory expectations.
Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka is building its core team and is looking for top talent who are passionate about making a difference.