Job Title:Quality Control Bioassay and Virology Operations Lead
Position Summary:
This role is responsible for the daily management and operations of the QC Bioassay and Virology Testing team within the QC Operations department, supporting clinical and commercial AAV-based products. Key responsibilities include overseeing cGMP processes such as in-process, lot release, stability, and raw material testing. The role also involves managing quality systems, including deviations, CAPAs, OOS, change controls, and data integrity, as well as supporting audit readiness and ensuring team training. The position includes managing, coaching, and developing a team of 4+ analysts across various experience levels.
Key Responsibilities:
- Maintain a compliant, efficient, and safe cGMP laboratory in accordance with regulatory, site, and corporate standards.
- Manage daily QC operations for cGMP routine and non-routine testing of in-process samples, drug substances, final products, virus banks, and cell banks.
- Review and approve equipment validation protocols, ensuring all QC instrumentation remains validated and compliant.
- Manage QC supplies, including critical reagents and controls.
- Support method validation and facilitate analytical technology transfers in collaboration with QC Technical Services and QA.
- Lead quality management systems such as Change Controls, Deviations, OOS, CAPA, and other essential processes.
- Author or review detailed documentation including retest protocols, investigations, CMC regulatory sections, SOPs, and more.
- Oversee data and KPI trending to maintain quality metrics.
- Conduct risk assessments to support QC Operations and ensure regulatory compliance for both internal and external audits.
- Drive continuous improvements in processes and procedures to enhance compliance and efficiency.
- Represent QC at cross-departmental meetings and maintain strong relationships with key stakeholders.
- Train and develop team members to meet business needs and career goals.
Requirements:
- Bachelor's degree in Life Sciences or Engineering.
- 10-15 years of experience in cGMP QC testing within Bioanalytical/Bioassay/Virology, with 8-10 years of leadership experience.
- Technical expertise in large molecule, gene, or cell therapy; cell culture experience required.
- Strong analytical, problem-solving, communication, organizational, and time-management skills.
- Proven ability to mentor and develop staff and work collaboratively with diverse teams.
Physical Requirements:
- Frequently work in a BSL-2 environment with appropriate PPE and aseptic techniques.
- Regular exposure to large machinery, typical pharmaceutical utilities, and occasionally to mechanical parts, high areas, hazardous chemicals, and loud noise levels.
- Frequent standing, walking, and lifting up to 25 pounds; occasional lifting up to 50 pounds.
- Strong close vision and communication abilities necessary.