Senior Quality Assurance Director, Biotech (Remote)

Jobgether; United States; Remote; USD 117,000 - 189,000; Full time

Benefits offered by this job

Remote work within US

Competitive salary

Annual bonus

401(k) plan

Healthcare coverage

Paid time off

Well-being programs

Job summary

Jobgether is seeking a senior Quality Assurance leader to design and oversee a scalable QMS aligned with our development stage, product pipeline, and regulatory obligations. You will drive GxP oversight across internal teams and external partners, and lead CAPAs, deviation management, change control, and training.

You will support regulatory submissions, inspections, and health authority interactions, while partnering with technical operations on CMC activities, tech transfers, and manufacturing

Qualifications

• Bachelor’s degree or higher in Life Sciences, Chemistry, Pharmacy, or a related scientific discipline.
• 8+ years in pharmaceutical quality roles, including leadership experience.
• Strong knowledge of FDA/EMA/ICH GxP requirements and life‑cycle quality standards.
• Hands‑on with document control and QMS tools (ZenQMS/Veeva Vault/MasterControl).

Responsibilities

• Design, implement, and continuously improve a scalable Quality Management System.
• Provide GxP quality oversight across internal and external partners.
• Lead deviation management, CAPA, change control, document control, and training.
• Support regulatory submissions, inspections, and health authority interactions.
• Partner with operations and development on CMC activities and tech transfers.
• Oversee batch record reviews, product release, and QA documentation.
• Coordinate audits and build a small QA team through cross‑functional collaboration.
• Support ongoing quality initiatives as business needs evolve.

Skills

GxP oversight

Leadership

Cross-functional teamwork

Regulatory knowledge

Education

Bachelor's degree in Life Sciences or related

Tools

ZenQMS

Veeva Vault

MasterControl

Job description

Jobgether is seeking a senior Quality Assurance leader to design and oversee a scalable QMS aligned with our development stage, product pipeline, and regulatory obligations. You will drive GxP oversight across internal teams and external partners, and lead CAPAs, deviation management, change control, and training.

You will support regulatory submissions, inspections, and health authority interactions, while partnering with technical operations on CMC activities, tech transfers, and manufacturing