AD/Director, Quality Assurance

AdeptSource (Adeptsource Inc); Redwood City (CA); On-site; USD 181,000 - 214,000; Full time

Job summary

An innovative company in the pharmaceutical sector is on the lookout for a dedicated Associate Director / Director of Quality Assurance. This pivotal role involves developing and implementing GXP quality systems, ensuring compliance with global regulations, and overseeing audit activities. The ideal candidate will possess extensive experience in quality assurance within a fast-paced environment and will have a proven track record in managing inspections and quality systems. If you are passionate about quality assurance and eager to make a significant impact in a dynamic organization, this opportunity is perfect for you.

Qualifications

• 10+ years in pharmaceutical quality assurance.
• Extensive knowledge of GXP regulatory requirements.

Responsibilities

• Develop and implement GXP quality systems.
• Conduct audits and ensure compliance oversight.
• Manage quality systems and vendor relationships.

Skills

GXP quality systems

GMP regulations

Quality systems design

Risk management tools

Inspection readiness

Interpersonal communication

Organizational skills

Education

Bachelor’s degree in biological sciences

Job description

Title: AD/Director, Quality Assurance, Pharma

Location: Redwood City, CA

Type of role: FTE, Full time Salary: 181K - 214K plus bonus and equity

Our direct client is seeking an Associate Director / Director of Quality Assurance to join their growing company.

Job Description

• Develop and implement GXP including GMP quality systems in accordance with ICH, FDA, EMA, and global competent authority regulations and industry guidance.
• Review all GXP documents/reports, especially those related to method development, validation activities, and PPQ generation results.
• Provide compliance oversight for internal and contracted external GXP activities.
• Coordinate and implement audit plans and reports for CROs, CDMOs, GMP vendors, and internal departments.
• Conduct virtual or on-site audits as needed.
• Oversee GMP CDMOs, including quality agreements, and manage GMP batch record review and disposition.
• Lead inspection readiness activities for internal and external entities.
• Host GMP inspections and follow up with responses and CAPAs.
• Develop and manage quality systems including vendor management, change control, product label review, risk management, GXP computer systems, deviations, and CAPA systems.
• Develop and implement GXP strategy, performance metrics, analytics, and reports.
• Ensure periodic SOP trainings for all employees, including onboarding FTEs and contractors.

Qualifications

• Bachelor’s degree in biological sciences or related field with at least 10 years’ experience in a pharmaceutical setting.
• Extensive knowledge of worldwide GXP regulatory requirements, industry practices, and application skills. Experience with GMP regulations and current standards.
• Experience designing and implementing quality systems and risk management tools.
• Experience managing CMOs for DS and DP, especially for biological products.
• Experience leading US and international health authority inspections.
• Excellent interpersonal, verbal, and written communication skills.
• Strong organizational, prioritization, and management skills.
• Ability to work effectively in a fast-paced small company environment and adapt to changing priorities.