Associate Director, Product Quality & Compliance

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

Benefits offered by this job

Competitive base salary

Performance bonus

401(k) and pension

Healthcare coverage

Paid time off

Remote work within US

Job summary

Jobgether is listing an Associate Director, Product Quality based in the United States through a partner company. The role focuses on building and scaling QA systems to ensure GxP compliance across development, manufacturing, and regulatory submissions.

You will lead a small QA team, work with CDMOs/CROs, and mentor staff in a fast-paced biopharma environment. Remote within the United States with up to 20% travel, this position offers a competitive base salary and performance bonuses, plus

Qualifications

• Bachelor's degree or higher in Life Sciences, Chemistry, Pharmacy, or related discipline.
• 8+ years in pharmaceutical quality roles, including 3+ years in leadership.
• Deep knowledge of FDA/EMA/ICH GxP guidelines.
• Experience with quality systems and document control.
• Experience with external CDMOs and different dosage forms.

Responsibilities

• Design and implement scalable QMS aligned with development stage and regulatory obligations.
• Provide GxP quality oversight across internal and external partners.
• Lead deviation management, CAPAs, change control, document control, and training.
• Support regulatory submissions and product release activities.
• Collaborate with CMC teams on tech transfers, scale-up, and process readiness.
• Oversee batch record reviews and product release decisions.
• Coordinate regulatory inspections and third-party audits.
• Recruit and lead a small QA team; foster cross-functional relationships.
• Support additional quality initiatives.

Skills

Leadership

Cross-functional collaboration

GxP regulations

Quality management systems

Regulatory submissions

Documentation control

External partner management

Strategic thinking

Education

Bachelor's degree or higher in Life Sciences, Chemistry, Pharmacy, or related

Tools

ZenQMS

Veeva Vault

MasterControl

Job description

Jobgether is listing an Associate Director, Product Quality based in the United States through a partner company. The role focuses on building and scaling QA systems to ensure GxP compliance across development, manufacturing, and regulatory submissions.

You will lead a small QA team, work with CDMOs/CROs, and mentor staff in a fast-paced biopharma environment. Remote within the United States with up to 20% travel, this position offers a competitive base salary and performance bonuses, plus