Job Description

Title: Director, Quality Assurance, Pharma
Location: Redwood City, CA (hybrid model)
Type of role: FTE, Full time Salary: plus bonus and equity
Our start-up Biotech client is seeking an Associate Director / Director Quality Assurance to join their growing company. Ideal candidate will be a hands-on Director who brings broad QA experience in the biologics industry.
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 as they relate 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 audit reports for all CROs, CDMOs, and GMP vendors and internal departments.
Coordinate and perform virtual or on-site audits as needed
Provide quality oversight for GMP CDMOs (including quality agreements) and manage GMP product batch record review and disposition.
Lead and ensure inspection readiness activities for all internal and external entities
Host GMP inspections. Follow up to any responses and CAPAs
Develop, implement, and manage the quality management systems including vendor management, change control, product label review, risk management, GXP computer systems, deviation and CAPA systems
Develop and implement overall GXP strategy, performance metrics, analytics, and reports
Ensure and record periodic SOP trainings for all employees including onboarding FTEs and contractors in the GXP system as applicable
Qualifications
Bachelors degree in biological sciences or related field with minimum of 10 years experience in a pharmaceutical setting.
Proven, extensive knowledge of worldwide GXP regulatory requirements, industry practices, and ability to apply concepts. Experience with GMP regulations and current industry standards.
Experience in designing and implementing quality systems and risk management tools
Experience interacting with and managing CMOs for DS and DP especially biological products
Experience leading/hosting US and international health authority inspections/interactions
Excellent interpersonal, verbal, and written communication skills are critical in our collaborative work environment
Must demonstrate high organizational, prioritization and management proficiencies
Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities
#J-18808-Ljbffr

Job Tags

Full time, For contractors, Worldwide,

Similar Jobs

Zobility

Financial Analyst Job at Zobility

...Job Description Job Description Job Title: Financial Analyst Product Development (California) Location: Newark California (Remote not available; local candidates only) Type: 2 Months Contract (Possible Extension) About the Role: Join our Product...

LeaderStat

Travel Psychiatric Adolescent Registered Nurse Job at LeaderStat

...Job Description LeaderStat is seeking a travel nurse RN Psychiatric for a travel nursing job in Holyoke, Massachusetts. Job Description & Requirements ~ Specialty: Psychiatric ~ Discipline: RN ~ Start Date: ASAP ~ Duration: 13 weeks ~40 hours per week...

Boyne Resorts

Lift Attendant (Winter) | Part Time Job at Boyne Resorts

...be energetic, outgoing, and able to interact with guests in a friendly and fun manner. As a customer focused organization, a crucial part of each employee's job is to get and keep guests. Responsibilities Assists with the shoveling and raking of snow and ice...

Equinox

Personal Trainer, High Line Job at Equinox

...Job Description Job Description What makes Personal Training with Equinox stand out? Equinox is proudly recognized as the industry leader in Personal Training expertise, with the first in-house education of its kind through the Equinox Fitness Training Institute...

Disability Solutions

Summer 2026 Intern - Statistics Data Management Analyst - IT Job at Disability Solutions

...to, economics, finance and accounting, information systems, and data analysis. The Board believes that by combining academic endeavors... ...About This Role As a Statistics Data Management Analyst intern, you will work in the Statistics area of the Information...

Director, Quality Assurance (Pharma) (Redwood City) Job at AdeptSource (Adeptsource Inc), Redwood City, CA

dGp4Skh3OGlpRWhmdkVvWFZPQzc5eUU2RlE9PQ==