Associate Director, Product Quality

Ladders; États-Unis; À distance; USD 117 000 - 189 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Vacation benefits

Medical insurance

Dental plan

Vision plan

Life insurance

Well-being programs

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GxP compliance

Quality management

Regulatory submissions

Vendor management

CAPA leadership

Document control

CDMO knowledge

Formation

BS in Life Sciences or related

Outils

ZenQMS

Veeva Vault

MasterControl

Description du poste

For our client, we are seeking an Associate Director, Product Quality to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will oversee product quality strategy and execution across development-stage programs, with a strong focus on GxP compliance and outsourced manufacturing partners. The Associate Director will help build scalable quality systems, guide release readiness, and support regulatory-facing activities that are critical to advancing products through the development lifecycle. This position will also partner closely with internal teams and external vendors to strengthen quality oversight, inspection preparedness, and overall product integrity.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $117,000 – $189,200 annually

Responsibilities

• Design, implement, and scale a Quality Management System (QMS) for the development stage
• Provide GxP compliance oversight for internal functions and outsourced partners, ensuring robust supplier management
• Lead quality function activities, including deviations, CAPAs, change control, and document control
• Serve as quality lead for regulatory submissions and clinical trial material release
• Drive quality input for tech transfers, CMC activities, and scale-up plans
• Oversee batch record review and product release processes
• Prepare the organization for regulatory inspections and audits, serving as a primary quality representative

Qualifications

• BS or higher in Life Sciences, Chemistry, Pharmacy, or a related field
• 8+ years of experience in pharmaceutical quality roles, including 3+ years in a leadership position
• Experience with document control software such as ZenQMS, Veeva Vault, or MasterControl
• Strong knowledge of GxP regulations, including FDA, EMA, and ICH guidance, and quality best practices across the product lifecycle
• Familiarity with multiple dosage forms and CDMO-based manufacturing

Benefits

• Eligibility to participate in a company-sponsored 401(k) and pension plan
• Vacation benefits and flexible spending accounts for healthcare and dependent care
• Comprehensive medical, dental, vision, and prescription drug benefits
• Life insurance and death benefits
• Well-being benefits including employee assistance programs and fitness benefits

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.