The Manager, Quality Assurance - East Coast is responsible for leading and overseeing Quality Assurance (QA) and Quality Control (QC) activities at the East coast manufacturing site. This role provides day-to-day quality leadership and oversight to ensure manufacturing activities, materials, testing, documentation and product release are performed in accordance with cGMP regulations, approved procedures, internal quality standards, and applicable regulatory requirements. This manager will overseen the site QC and QA teams and serve as a key quality partner to Manufacturing, Supply Chain, MSAT and other cross functional stakeholders.
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.
Essential Duties & Key Responsibilities:- Provide operational leadership of the site Quality function, including QA Operations, Quality Systems, QC, and Compliance.
- Ensure site Quality activities are conducted in compliance with cGMP requirements, applicable regulatory expectations, approved procedures and Orca Bio quality standards.
- Serve as the primary site Quality partner to Manufacturing and other cross functional teams, providing timely quality guidance and escalation when needed.
- Maintain a strong state of inspection readiness and promote a culture of quality, compliance and continuous improvement.
- Oversee batch record review and disposition of products and materials, ensuring timely and compliant release.
- Lead and manage deviation investigations, change control, CAPA, and complaint management systems.
- Partner with Manufacturing, MSAT, Supply Chain, Regulatory, and R&D to support production timelines, tech transfers, and product development milestones.
- Ensure robust quality oversight of raw materials, in-process materials, and finished goods, including oversight of QC laboratory operations and testing.
- Lead and oversee QC activities supporting site manufacturing operations to ensure QC testing activities are appropriately planned and scheduled to support manufacturing and product release timelines.
- Provide oversight of laboratory investigations, atypical results, out of specification results and other QC related events.
- Support assay transfer, validation, qualification and implementation activities as applicable.
- Develop and implement site quality metrics and dashboards to monitor performance and drive continuous improvement initiatives.
- Participate in global Quality leadership forums to align site practices with corporate standards and strategy.
Minimum Qualifications:- Bachelor's degree in a scientific or engineering discipline required; advanced degree (MS, PhD, PharmD) preferred.
- 7+ years of experience in pharmaceutical or biotech manufacturing quality, with at least 5 years in a leadership role or proven excellent in role.
- Strong background in cGMP regulations and clinical manufacturing (Phase I-III); experience with biologics, cell & gene therapies, or sterile manufacturing is highly desirable.
- Deep knowledge of GMP and global regulatory standards (FDA, EMA, ICH, etc.).
- Proven ability to lead cross-functional teams in a dynamic, fast-paced clinical environment.
- Excellent problem-solving, communication, and decision-making skills.
- Experience managing regulatory inspections and building compliant quality systems from the ground up is a plus.
- Strong interpersonal skills and the ability to influence at all levels of the organization.
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.
$120,000 - $150,000 a year
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.
