Supervisor, Quality Assurance (Swing Shift)

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 commercial-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 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. The Supervisor, Quality Assurance, is responsible for overseeing day-to-day activities of the QA team directly supporting manufacturing and quality control operations. This role provides direct support to the site to ensure compliance with regulatory standards, internal procedures, and quality expectations. The QA Supervisor provides leadership and guidance to the QA team, driving a culture of continuous improvement, compliance, and operational excellence. The department is responsible for performing real-time record review of production records, equipment logbooks, and QC documentation. Additionally, this department collaborates across the site to provide real time manufacturing support, supporting issue resolution and documentation. Swing Shift Schedule: • Monday - Friday, 2:00pm to 10:30pm Physical Demands & Work Conditions

Production Associates: 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.

Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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.

Must be comfortable regularly participating in video-based meetings.

Key Responsibilities

Leadership and Team Management:

• Supervise, mentor, and develop a team of QA technicians assigned to manufacturing and QC operations.
• Schedule and prioritize daily QA activities to ensure timely support for production and lab functions.
• Provide ongoing training, performance evaluations, and career development support for team members.
• Serve as QA representative in cross-functional meetings related to operations and quality systems, promoting a culture of compliance and continuous improvement.
• Provide technical guidance and mentorship to ensure high quality and compliant practices.

Operational Support:

• Oversee on-the-floor QA support for manufacturing and QC activities including batch record review, in-process checks, line clearance, and deviation response.
• Ensure timely review and approval of manufacturing and QC documentation (e.g., batch records, logbooks, equipment use records, test data).
• Support real-time issue resolution during production and testing activities, escalating concerns as needed.
• Monitor compliance with Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and internal SOPs.
• Assist in the preparation and review of master batch records, standard operating procedures (SOPs), and other relevant documentation.

Quality Systems & Compliance:

• Supervisors are expected to supervise Quality System performance for themselves and their team.
• Ensure effective implementation and adherence to quality systems including deviation management, CAPAs, change control, and investigations.
• Review and approve deviations, investigations, and change controls related to manufacturing and QC.
• Participate in internal audits, regulatory inspections, and third-party audits as required.
• Support trending of quality data and contribute to continuous improvement initiatives.
• Collaborate with cross-functional teams (QC, Manufacturing, MSAT, etc.) to drive resolution of quality and technical issues.

Record Management Readiness:

• Monitor record management conditions and practices to ensure consistent compliance with cGMP and FDA/EMA regulations.
• Manage documentation, equipment logs, and records to support readiness for internal and external inspections.
• Lead preparation activities for audits and regulatory inspections, including document reviews and mock audits.

Continuous Improvement, Collaboration, and Communication:

• Identify opportunities to enhance operations, workflow efficiency, and compliance practices.
• Participate in the revision and development of SOPs and policies.
• Liaise with Manufacturing, QC, Validation, Engineering, and other departments to ensure QA oversight and alignment.
• Communicate quality expectations, regulatory changes, and quality system updates to the team and relevant stakeholders.
• Support implementation of new procedures, processes, and equipment from a QA perspective.
• Perform other duties as requested by supervisor/manager to support Quality.
• Stay current with industry regulations, standards, and best practices related to quality assurance.

Minimum Qualifications

Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related scientific discipline

Minimum of 5 years of experience in Quality Assurance within a regulated pharmaceutical, biotechnology, or medical device environment.

Minimum of 1-2 years in a leadership or supervisory role is preferred.

Strong knowledge of cGMP, FDA, and ICH guidelines.

Strong analytical, problem-solving, and decision-making skills.

Excellent written and verbal communication.

Detail-oriented with strong organizational skills.

Ability to manage multiple priorities and work in a fast-paced environment.

The anticipated annual salary range (listed above) 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.