The Sr. QA Specialist – Supplier Quality leads the qualification and ongoing quality oversight of third parties, including suppliers, service providers, and contract development and manufacturing organizations (CDMOs), and supports key quality system functions to ensure compliance with cGMP and regulatory standards in a biotech environment. With over five years of experience, this role manages complex investigations, oversees change control and CAPA processes, supports regulatory inspections, and mentors junior QA staff. The specialist drives continuous improvement and cross-functional collaboration to uphold product quality and operational excellence.
Duties and Responsibilities (Responsibilities include but are not limited to):- Lead risk-based qualification and requalification of third parties, including suppliers and service providers, through assessments, audits, and documented recommendations for approval.
- Manage ongoing third-party quality oversight, including performance monitoring, quality agreements, change notifications, and follow-up on quality issues and corrective actions.
- Maintain third-party qualification records and approved status, ensuring timely periodic reviews and escalation of quality and compliance risks.
- Manage contractors and consultants performing third-party audits, including audit scope, scheduling, and deliverable review; independently plan and conduct audits, prepare reports, and follow up on corrective actions.
- Lead and execute quality oversight of manufacturing and QC operations, including executed batch record review, deviations, investigations, risk assessments, change control, SOPs and cross-functional liaison to ensure compliance with cGMP and internal quality standards.
- Independently lead quality-driven projects and present key quality metrics, training initiatives, and validation documentation reviews to leadership and cross-functional teams.
- Drive ownership of quality systems, including change control, CAPA, and document management, with accountability for process improvement and regulatory alignment.
- Author, review, and approve controlled documentation, including SOPs, batch records, and work instructions, ensuring accuracy, completeness, and adherence to applicable regulatory standards.
- Perform batch disposition activities by reviewing batch records, in-process and release testing results, environmental monitoring records, Certificates of Analysis (CoAs), deviation investigations, and quality event closures to determine and document batch approval or rejection decisions.
- Inspect and approve raw materials, packaging components, and in-process materials against approved specifications and/or CoAs, ensuring compliance with internal standards, regulatory expectations, and release criteria prior to use in manufacturing operations.
- Provide QA floor support during manufacturing process as needed
- Other duties/responsibilities as assigned.
Supervisory Responsibilities:This position does not have supervisory responsibilities. Mentors junior QA staff as needed.
Education/Experience/Skills:- BS/BA in life sciences
- 5+ years of quality assurance experience in a regulated manufacturing environment required (FDA, EMA, MHRA, Health Canada). Pharmaceutical or related industry experience is highly preferred.
- Hands-on experience qualifying, auditing, and overseeing GMP suppliers and service providers required, including risk assessments, quality agreements, and corrective-action follow-up.
- Experience qualifying and overseeing GLP and GCP service providers, including nonclinical laboratories and clinical research organizations, preferred.
- Must have strong communication skills. Demonstrated proficiency in Microsoft Office software (Word, Excel, PowerPoint and Outlook).
- Ability to effectively present information in one-on-one, small groups and company meetings.
- Must be able to aseptically gown, as needed, to support QA on the floor activities in clean rooms and practice aseptic behavior in controlled areas.
- Utilizes established mathematical and scientific techniques to compile and analyze data.
- Familiar with eQMS functionality. Experience implementing an eQMS is highly desirable.
- Demonstrates self-motivation, initiative, and accountability in managing priorities, completing assignments, and proactively identifying opportunities for process improvement.
Working Environment and Travel:While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must regularly lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus.
Normal office environment with some exposure to lab areas. The noise level in the working environment is usually moderate.
Domestic and international travel to supplier locations, CDMOs, and SAB company locations is a regular component of this position. Travel is expected to be ~50%.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
This job description will be reviewed periodically as duties and responsibilities change with business necessity. Primary and additional duties and responsibilities are subject to modification.
SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
This is a Remote role.