Sr. QA Specialist, Supplier Quality
About The Position
The Sr. QA Specialist – Supplier Quality leads qualification and ongoing quality oversight of third parties, including suppliers, service providers, and contract development and manufacturing organizations (CDMOs), and supports quality system functions to ensure compliance with cGMP and regulatory standards in a biotech environment. The role manages complex investigations, change control, and CAPA processes; supports regulatory inspections; and mentors junior QA staff. It drives continuous improvement and cross-functional collaboration to uphold product quality and operational excellence. The position leads risk-based third-party qualification and requalification, manages third-party performance and quality issues, and maintains qualification records and approved status. It also oversees audits, manufacturing and QC quality activities, quality systems, controlled documentation, and batch disposition. The role provides QA floor support as needed and includes regular domestic and international travel, expected to be approximately 50%. This is a remote role.
Requirements
- BS/BA in life sciences.
- At least 5 years of quality assurance experience in a regulated manufacturing environment, such as FDA-, EMA-, MHRA-, or Health Canada-regulated environments.
- Hands-on experience qualifying, auditing, and overseeing GMP suppliers and service providers, including risk assessments, quality agreements, and corrective-action follow-up.
- Strong communication skills.
- Proficiency with Microsoft Office software, including Word, Excel, PowerPoint, and Outlook.
- Ability to present information effectively one-on-one, in small groups, and at company meetings.
- Ability to aseptically gown as needed to support QA floor activities in clean rooms and to practice aseptic behavior in controlled areas.
- Ability to use established mathematical and scientific techniques to compile and analyze data.
- Familiarity with eQMS functionality.
- Self-motivation, initiative, and accountability in managing priorities, completing assignments, and proactively identifying process-improvement opportunities.
Nice To Haves
- Pharmaceutical or related industry experience.
- Experience qualifying and overseeing GLP and GCP service providers, including nonclinical laboratories and clinical research organizations.
- Experience implementing an eQMS.
Responsibilities
- Lead risk-based qualification and requalification of third parties, including suppliers and service providers, through assessments, audits, and documented approval recommendations.
- 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, ensure timely periodic reviews, and escalate 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 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.
- Perform batch disposition by reviewing batch records, in-process and release testing results, environmental monitoring records, Certificates of Analysis, deviation investigations, and quality event closures to determine and document batch approval or rejection.
- Inspect and approve raw materials, packaging components, and in-process materials against approved specifications and/or Certificates of Analysis before use in manufacturing.
- Provide QA floor support during manufacturing as needed.
- Mentor junior QA staff as needed.
- Perform other duties and responsibilities as assigned.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
