Manager, Quality Control

Position Summary:

The Manager, Quality Control is responsible for providing oversight for the GMP testing of cell therapy products and critical intermediates. Additionally, this role will support regulatory and internal inspections and oversee key aspects of quality control workflows, including leading investigations of out‑of‑specification results and addressing environmental monitoring excursions. This position will work cross-functionally to ensure that products are sampled and tested under applicable regulations and guidelines of current Good Manufacturing Practices (cGMPs). There are regular interactions with internal manufacturing and with service providers. The successful candidate shall be an experienced manager with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.

Physical Demands

• _Production Associate Roles_ : Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• _Most roles_ must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

Work Conditions

• _Many roles_ must be able to work at either Orca Bio Sacramento locations (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

Key Responsibilities:

• Lead GMP testing operations and meet critical business goals.
• Oversee day-to-day operations associated with raw material testing, in-process testing, and release and stability testing of clinical and commercial cell therapy products. Perform data reviews and release completed test results. Provide oversight for microbiology testing and environmental monitoring.
• Plan, forecast, and allocate laboratory resources and equipment to ensure efficient execution of quality control testing, including managing staffing levels, scheduling workflows, maintaining instrument availability, and coordinating procurement and maintenance to meet project timelines and regulatory requirements.
• Provide supervision of QC associates; assess, plan and manage resource allocations for QC; define training requirements and manage training status of QC staff as required to execute activities of the function; schedule QC and EM projects and schedules.
• Hire, mentor and develop QC personnel, including QC Supervisors.
• Contribute to the design, implementation and continuous improvement of Quality Control systems that are technically sound, promote effective and efficient operations, comply with cGMP requirements and meet commercial stage standards. Review and approve test methods and procedures associated with QC activities
• Provide leadership support during trouble shooting of assay performance and equipment as it relates to ensuring the quality and compliance of the product.
• Collaborate with analytical development on updates and validation of test methods. Define method trending metrics and perform method trending
• Identify and mitigate risks in QC labs that could negatively impact the safety, identity, strength purity or quality of the product.
• Define requirements and lead equipment qualification, maintenance and calibration practices and manage instrument capacity
• Participate in outsourcing decisions and oversight of contract testing organizations for specific tests as needed
• Contribute and lead direct interactions with Regulatory agencies (audits, etc.).
• Responsible for generating environmental monitoring reports and managing the environmental monitoring program for the site.

Required Experience

• 7+ years of relevant experience in quality control, or a related field such as analytical development or quality assurance and a BS or BA; or 5+ years of relevant experience and a MA/MS/MBA. At least 2 years of experience managing personnel.
• Knowledge of global regulatory requirements, guidance and best practices for biopharmaceuticals and advanced therapies such as cell and gene therapies.
• Experience and knowledge of environmental monitoring programs, including ISO 14644 and EU Annex 1.
• Experience with the application of cGMPs, USP/NF, FDA guidelines, EU regulations and ICH guidelines in the pharmaceutical industry.
• Experience with flow cytometry and cell therapies is strongly preferred.
• Experience with standard biologic safety testing, e.g. endotoxin and sterility per USP <71>.
• Experience with implementation and use of LIMS and other quality management system software; experience with implementing, improving and ensuring robust data integrity approaches.
• Experience in preparing for and participating in quality and regulatory audits.
• Experience with risk management and qualification of raw materials and vendors/contract service providers.
• Ability to identify and elevate issues and support solutions.
• Excellent oral and written communications skills and a collegial personality. Thrives and succeeds in a team-oriented environment.
• Ability to work in a fast-paced environment, to multitask and manage multiple projects.
• Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement.