Remote! Associate Director, Product Quality

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

Benefits offered by this job

401(k) plan

Vacation benefits

Medical insurance

Dental plan

Vision plan

Life insurance

Well-being programs

Job summary

Ladders is seeking an Associate Director, Product Quality to lead GxP quality strategy across development programs in the Pharmaceuticals & Biotech space. This role oversees QMS design, release readiness, and regulatory-facing activities while coordinating with internal teams and outsourced manufacturing partners.

The ideal candidate has 8+ years of pharma quality experience, including leadership, and hands-on knowledge of document control systems, CDMOs, and regulatory expectations from

Qualifications

• BS or higher in Life Sciences, Chemistry, Pharmacy, or related field.
• 8+ years in pharmaceutical quality roles, including 3+ years in leadership.
• Experience with document control software such as ZenQMS, Veeva Vault, or MasterControl.
• Strong knowledge of GxP regulations (FDA/EMA/ICH) and product lifecycle quality practices.

Responsibilities

• Design, implement, and scale a QMS for development-stage programs.
• Provide GxP compliance oversight for internal functions and outsourced partners.
• Lead quality function activities: deviations, CAPAs, change control, document control.
• Serve as quality lead for regulatory submissions and clinical material release.
• Drive quality input for tech transfers, CMC activities, scale-up plans.
• Oversee batch record review and product release processes.
• Prepare the organization for regulatory inspections and audits.

Skills

GxP compliance

Quality management

Regulatory submissions

Vendor management

CAPA leadership

Document control

CDMO knowledge

Education

BS in Life Sciences or related

Tools

ZenQMS

Veeva Vault

MasterControl

Job description

Ladders is seeking an Associate Director, Product Quality to lead GxP quality strategy across development programs in the Pharmaceuticals & Biotech space. This role oversees QMS design, release readiness, and regulatory-facing activities while coordinating with internal teams and outsourced manufacturing partners.

The ideal candidate has 8+ years of pharma quality experience, including leadership, and hands-on knowledge of document control systems, CDMOs, and regulatory expectations from