Manager, Quality Control

Job Description

Job Description

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.   With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

 

We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

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 location (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. 

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

 

Who we are

 

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

 

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

 

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

 

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

 

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

 

Notice to staffing firms

 

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.